[{"id":6476,"date":"2026-09-28T21:45:00","date_gmt":"2026-09-28T21:45:00","guid":{"rendered":"https:\/\/egetiscorpostg.wpenginepowered.com\/news\/egetis-therapeutics-announces-u-s-fda-approval-of-emcitate-tiratricol-for-patients-with-mct8-deficiency-2\/"},"modified":"2026-09-29T08:53:40","modified_gmt":"2026-09-29T08:53:40","slug":"egetis-therapeutics-announces-u-s-fda-approval-of-emcitate-tiratricol-for-patients-with-mct8-deficiency","status":"publish","type":"mfn_news","link":"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-announces-u-s-fda-approval-of-emcitate-tiratricol-for-patients-with-mct8-deficiency\/","title":{"rendered":"Egetis Therapeutics Announces U.S. FDA Approval of EMCITATE\u00ae (tiratricol) for Patients with MCT8 Deficiency"},"content":{"rendered":"<div class=\"mfn-body\">\n<ul>\n<li><strong>First and only FDA-approved treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency in the United States<\/strong><\/li>\n<li><strong>Egetis launches Egetis RareLink\u2122, the EMCITATE patient support program, in partnership with PANTHERx\u00ae Rare<\/strong><\/li>\n<li><strong>FDA granted Egetis a Rare Pediatric Disease Priority Review Voucher (PRV) in connection with the approval<\/strong><\/li>\n<li><strong>Egetis to host a conference call and webcast for analysts and investors on Tuesday September 29 at 8:00 am CEST (2:00 am EDT)<\/strong><\/li>\n<\/ul>\n<p><strong>STOCKHOLM, SWEDEN, September 28, 2026. <\/strong>\u2013 Egetis Therapeutics AB (publ) (&#34;Egetis&#34; or the &#34;Company&#34;) (Nasdaq Stockholm: EGTX) today announced that the U.S. Food and Drug Administration (FDA) has approved EMCITATE\u00ae (tiratricol), a thyroid hormone receptor agonist, for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan\u2013Herndon\u2013Dudley syndrome). EMCITATE is not recommended for the treatment of primary hypothyroidism. EMCITATE is the first FDA-approved treatment option for patients with MCT8 deficiency in the United States.<\/p>\n<p>MCT8 deficiency is a rare, devastating, life-limiting, X-linked disorder caused by pathogenic mutations in the <em>SLC16A2<\/em> gene. These mutations impair the function of MCT8, a critical cell-surface thyroid-hormone transporter responsible for thyroid hormone transport in specific cells, including in the brain. As a result, patients experience disrupted thyroid hormone signaling, characterized by insufficient thyroid hormone activity in the central nervous system and excessive exposure to the active thyroid hormone triiodothyronine (T3) in peripheral tissues. This leads to a complex disorder characterized by severe neurodevelopmental impairment and persistent peripheral thyrotoxicosis. Patients with MCT8 deficiency have a reported median life expectancy of approximately 35 years. For further details, please see \u2018About MCT8 deficiency\u2019 below.<\/p>\n<p>The FDA approval of EMCITATE was supported by a comprehensive clinical development program evaluating EMCITATE in patients with MCT8 deficiency, including ReTRIACt, Triac Trial I, Triac Trial II, Erasmus Medical Center (EMC) Cohort Study, EMC Survival Study and the U.S. Expanded Access Program.<\/p>\n<p>\u201c<em>Today marks a turning point for patients living with MCT8 deficiency and their caregivers, who have waited long for an approved treatment in the United States. Our immediate focus is ensuring that eligible patients can access EMCITATE as quickly as possible,\u201d<\/em> <strong>said Nicklas Westerholm, Chief Executive Officer of Egetis Therapeutics.<\/strong><br \/><em>\u201cWe are deeply grateful to the patients, caregivers, investigators, clinicians, and advocacy organizations whose partnership and determination made this achievement possible as well as all Egetis employees and collaborators for their dedicated and hard work. Today also marks a defining milestone for Egetis as we take steps forward in developing medicines that address serious unmet medical needs for patients with rare diseases.\u201d<\/em><\/p>\n<p>&#34;<em>Through my experience caring for patients with MCT8 deficiency, I have seen firsthand the profound impact this complex and life-limiting disorder can have on patients and their families. Early diagnosis is critical so that patients can be appropriately evaluated, connected with specialists and receive coordinated multidisciplinary care. The FDA approval of EMCITATE provides physicians in the United States with the first approved treatment option for patients and represents an important advance for the MCT8 deficiency community<\/em><em><strong>,\u201d<\/strong><\/em><strong> said Andrew J. Bauer, M.D.<\/strong>, a pediatric endocrinologist and expert in thyroid hormone disorders and Principal Investigator in ReTRIACt trial and Triac Trial II, evaluating EMCITATE in MCT8 deficiency.<\/p>\n<p><em>\u201cThe FDA approval of EMCITATE is a historic milestone for the MCT8 deficiency community and an important step toward ensuring patients have access to a treatment. We are grateful to Egetis and to the researchers, clinicians, patients, families, and advocates whose dedication helped bring this treatment to patients. This approval is a testament to what is possible when a community comes together with a shared commitment to advancing care. We look forward to continuing to advocate for patients and supporting efforts to expand awareness, access and treatment options for the worldwide MCT8 community.\u201d <\/em><strong>said the MCT8-AHDS Foundation<\/strong>.<\/p>\n<p><strong>Launch of Egetis RareLink\u2122: EMCITATE\u00ae comprehensive patient support program<\/strong><br \/>Egetis is committed to helping eligible patients gain timely access to EMCITATE. The Company expects EMCITATE to be commercially available in the United States in eight to ten weeks post approval. Through <strong>Egetis<\/strong> <strong>RareLink<\/strong>, its dedicated patient support program, Egetis has established the access infrastructure\u2014including specialty distribution and dedicated support resources\u2014to help ensure a seamless experience for patients, caregivers, and healthcare professionals from day one. As part of its U.S. commercialization strategy, Egetis has partnered with PANTHERx\u00ae Rare to support medication access, education, care coordination and ongoing treatment services. For more information about Egetis RareLink, call 1-844-4EGETIS (1-844-434-3847).<\/p>\n<p><strong>Priority review voucher granted<\/strong><br \/>In connection with the approval of EMCITATE, the FDA granted Egetis a Rare Pediatric Disease Priority Review Voucher (PRV). The Company currently expects to explore monetization of the PRV, which could potentially occur in the fourth quarter of 2026, subject to market conditions.<\/p>\n<p><strong>Conference call and webcast information<\/strong><br \/>Egetis will host a conference call and webcast for analysts and investors to discuss the FDA approval of EMCITATE beginning at 8:00 am CEST (2:00 am EDT) on Tuesday September 29, 2026.<br \/>Webcast link: <a href=\"https:\/\/live.events.inderes.com\/fda-approval-sep-2026\" rel=\"noopener\" target=\"_blank\">https:\/\/live.events.inderes.com\/fda-approval-sep-2026<\/a><br \/>Teleconference link: <a href=\"https:\/\/events.inderes.com\/live\/fda-approval-sep-2026\/dial-in\" rel=\"noopener\" target=\"_blank\">https:\/\/events.inderes.com\/live\/fda-approval-sep-2026\/dial-in<\/a><\/p>\n<p>After registration to the teleconference you will be provided phone numbers and a conference ID to access the call. You can ask questions verbally via the teleconference. A replay of the webcast can be accessed via the webcast link above.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-49727cfc9233\">\n<p><strong class=\"mfn-heading-1\">About MCT8 Deficiency<\/strong><\/p>\n<hr\/>\n<p>Monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan\u2013Herndon\u2013Dudley syndrome (AHDS), is a rare, devastating, life-limiting, X-linked disorder caused by pathogenic mutations in the <em>SLC16A2<\/em> gene. These mutations impair the function of MCT8, a critical cell-surface thyroid hormone transporter responsible for thyroid hormone transport in specific cells, including in the brain. As a result, patients experience disrupted thyroid hormone signaling, characterized by insufficient thyroid hormone activity in the central nervous system and excessive exposure to the active thyroid hormone triiodothyronine (T3) in peripheral tissues. This leads to a complex disorder characterized by severe neurodevelopmental impairment and persistent peripheral thyrotoxicosis.<\/p>\n<p>The elevated T3 concentrations in peripheral tissues can result in a chronic hypermetabolic state affecting multiple organs, including the heart, muscles, liver, and kidneys. Clinical manifestations may include failure to thrive, cardiovascular strain, muscle wasting, metabolic imbalance, and increased susceptibility to infections. These systemic consequences of persistent thyrotoxicosis are believed to contribute significantly to the increased morbidity and premature mortality associated with the disorder. Patients with MCT8 deficiency have a reported median life expectancy of approximately 35 years.<\/p>\n<p>For more information about MCT8 deficiency, please visit MCT8deficiency.com or LifewithMCT8deficiency.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-187dc5d37350\">\n<p><strong class=\"mfn-heading-1\">INDICATION AND USAGE<\/strong><\/p>\n<hr\/>\n<p>EMCITATE is a thyroid hormone receptor agonist indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan\u2013Herndon\u2013Dudley syndrome).<\/p>\n<p>Limitation of use: EMCITATE is not recommended for the treatment of primary hypothyroidism.  <\/p>\n<\/div>\n<div class=\"mfn-footer mfn-d3ec9c09c941\">\n<p><strong class=\"mfn-heading-1\">IMPORTANT SAFETY INFORMATION<\/strong><\/p>\n<hr\/>\n<p><strong>BOXED WARNING<\/strong><br \/>NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS<br \/><strong>\u00a0<\/strong><br \/><strong>CONTRAINDICATIONS<\/strong><br \/>Primary hyperthyroidism<br \/><strong>\u00a0<\/strong><br \/><strong>WARNINGS AND PRECAUTIONS<\/strong><br \/>Thyrotoxicosis: Signs and symptoms of thyrotoxicosis (e.g., increased heart rate, elevated blood pressure, diarrhea, hyperhidrosis, irritability, insomnia, nightmares) have occurred with EMCITATE during treatment initiation and dose titration. Monitor and adjust the EMCITATE dose as indicated.<br \/>Laboratory Test Interference for T3 Measurement: Tiratricol can cross-react with immunoassays for T3 leading to unreliable T3 results and cause an overestimation of T3.<br \/><strong>\u00a0<\/strong><br \/><strong>ADVERSE REACTIONS<\/strong><br \/>Most common adverse reactions (\u2265 5%): diarrhea, vomiting, rash, and hyperhidrosis.<br \/>To report SUSPECTED ADVERSE REACTIONS, contact Egetis Therapeutics US Inc. at 1-844-4EGETIS (1-844-434-3847) or FDA at 1-800-FDA-1088 or <a href=\"http:\/\/www.fda.gov\/medwatch\" rel=\"noopener\" target=\"_blank\">www.fda.gov\/medwatch<\/a>.<br \/>\u00a0<br \/><strong>Please see full Prescribing Information here:<\/strong><br \/><a href=\"https:\/\/www.egetis.com\/wp-content\/uploads\/emcitate-full-prescribing-information.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/www.egetis.com\/wp-content\/uploads\/emcitate-full-prescribing-information.pdf<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-cef580f51688\">\n<p><strong class=\"mfn-heading-1\">About Egetis Therapeutics<\/strong><\/p>\n<hr\/>\n<p>Egetis Therapeutics is a commercial-stage pharmaceutical company focused on developing and delivering innovative therapies for patients with rare diseases with significant unmet medical need. Combining scientific and clinical expertise with integrated late-stage development, regulatory and commercial capabilities and manufacturing expertise, Egetis is committed to delivering treatments and dedicated support to underserved patient communities.<br \/>The Company&#39;s lead product, EMCITATE\u00ae (tiratricol), is the first and only approved treatment for MCT8 deficiency, a rare and life-shortening genetic disorder, with marketing authorizations in the European Union and in the United States.<br \/>Headquartered in Stockholm, Sweden, with operations in the U.S. and Europe, Egetis is building a sustainable global rare disease company.<br \/>For more information, visit egetis.com and follow the Company on LinkedIn.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-21ce51984900\">\n<p><strong class=\"mfn-heading-1\">About PANTHERx Rare<\/strong><\/p>\n<hr\/>\n<p>  PANTHERx Rare makes rare disease care more hyper-personalized and less overwhelming by focusing relentlessly on each patient and each therapy. PANTHERx experts develop deep personal relationships with patients, prescribers, and pharmaceutical partners, serving as trusted advocates to ensure seamless collaboration and exceptional care. Since its founding in a garage in Pittsburgh, PA in 2011, PANTHERx has grown into the largest independent rare pharmacy in the U.S., leveraging established-company resources while maintaining small-company responsiveness, innovation, and attention to detail.<br \/>PANTHERx is licensed in all 50 states and U.S. territories and was the first national pharmacy to achieve dual accreditations in rare disease from the Accreditation Commission for Health Care (ACHC) and Utilization Review Accreditation Commission (URAC). PANTHERx is also the nine-time winner of the prestigious MMIT Patient Choice Award for patient satisfaction, including the 2026 honor.<br \/>For more information, please email\u202fTheRareSP@pantherxrare.com\u202for visit www.pantherxrare.com  <\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">For further information, please contact:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, CEO<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com\u00a0<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-regulatory mfn-regulatory-mar\">\n<p><em>This information is information that Egetis Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-09-28 23:45 CEST.<\/em><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Forward-looking statements<\/strong><\/p>\n<hr\/>\n<p>This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the commercialization and availability of Emcitate\u00ae (tiratricol) in the United States, the timing and outcome of potential monetization of the Rare Pediatric Disease Priority Review Voucher, the expected capabilities of the Company\u2019s patient access and distribution infrastructure, the anticipated benefits of Emcitate for patients with MCT8 deficiency, and the Company\u2019s broader strategic plans for the development and commercialization of therapies for rare diseases. Forward-looking statements can generally be identified by words such as \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cpotential,\u201d or similar expressions, although not all forward-looking statements contain these words.<br \/>These statements are based on the Company\u2019s current expectations, assumptions, and assessments as of the date of this press release and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to: risks related to the commercial launch and market acceptance of Emcitate in the United States; the ability to establish and maintain adequate commercial infrastructure, including distribution, patient support, and reimbursement arrangements; the timing and terms of any monetization of the Priority Review Voucher, which is subject to market conditions and the availability of interested purchasers; potential post-marketing requirements or restrictions imposed by the FDA; the ability to maintain regulatory approvals in the United States and the European Union; competition from existing or future therapies; the Company\u2019s ability to secure adequate funding for its operations and commercial activities; and general economic, market, and business conditions.<br \/>For a further description of risks and uncertainties that could affect the Company\u2019s business and results, reference is made to the Company\u2019s most recent annual report and other filings with relevant regulatory authorities available at <a href=\"http:\/\/www.egetis.com\/\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or regulation.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Attachments<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/fa731366-5bfc-4eda-8864-82bc41da6196\/egetis-therapeutics-announces-u-s-fda-approval-of-emcitate-r-tiratricol-for-patients-with-mct8-deficiency.pdf\" rel=\"noopener\" target=\"_blank\">Egetis Therapeutics Announces U.S. FDA Approval of EMCITATE\u00ae (tiratricol) for Patients with MCT8 Deficiency<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"First and only FDA-approved treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency in the United States Egetis launches Egetis RareLink\u2122, the EMCITATE patient support program, in partnership with PANTHERx\u00ae Rare FDA granted Egetis a Rare Pediatric Disease Priority Review Voucher (PRV) in connection with the approval Egetis to [&hellip;]","protected":false},"template":"","class_list":["post-6476","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn-regulatory"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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EMCITATE rekommenderas inte f\u00f6r behandling av prim\u00e4r hypotyreos. EMCITATE \u00e4r den f\u00f6rsta FDA-godk\u00e4nda behandlingen f\u00f6r patienter med MCT8-brist i USA.<\/p>\n<p>MCT8-brist \u00e4r en s\u00e4llsynt, allvarlig och livsbegr\u00e4nsande sjukdom som framf\u00f6r allt drabbar pojkar (X-kromosombunden) och som orsakas av mutationer i <em>SLC16A2<\/em>-genen. Dessa mutationer f\u00f6rs\u00e4mrar funktionen hos MCT8, ett viktigt transportprotein p\u00e5 cellytan som ansvarar f\u00f6r transport av sk\u00f6ldk\u00f6rtelhormoner i vissa celler, inklusive hj\u00e4rnans celler. Som en f\u00f6ljd av detta f\u00e5r patienterna en st\u00f6rd signalering av sk\u00f6ldk\u00f6rtelhormoner, k\u00e4nnetecknad av otillr\u00e4cklig sk\u00f6ldk\u00f6rtelhormonaktivitet i centrala nervsystemet och en \u00f6verexponering f\u00f6r det aktiva sk\u00f6ldk\u00f6rtelhormonet trijodtyronin (T3) i perifera v\u00e4vnader. Detta leder till en komplex sjukdomsbild som k\u00e4nnetecknas av sv\u00e5r neurologisk p\u00e5verkan och kvarst\u00e5ende perifer tyreotoxikos. Patienter med MCT8-brist har en rapporterad medianlivsl\u00e4ngd p\u00e5 cirka 35 \u00e5r. F\u00f6r ytterligare information, se avsnittet \u201dOm MCT8-brist\u201d nedan.<\/p>\n<p>FDA:s godk\u00e4nnande av EMCITATE baserades p\u00e5 ett omfattande kliniskt utvecklingsprogram som utv\u00e4rderade EMCITATE hos patienter med MCT8-brist, i ReTRIACt, Triac Trial I, Triac Trial II, Erasmus Medical Center (EMC) Cohort Study, EMC Survival Study, samt det amerikanska Expanded Access-programmet<\/p>\n<p><em>&#34;Godk\u00e4nnandet markerar en v\u00e4ndpunkt f\u00f6r patienter som lever med MCT8-brist och deras n\u00e4rst\u00e5ende, som l\u00e4nge v\u00e4ntat p\u00e5 ett godk\u00e4nt behandlingsalternativ i USA. V\u00e5rt fr\u00e4msta fokus \u00e4r att s\u00e4kerst\u00e4lla att patienter f\u00e5r tillg\u00e5ng till EMCITATE s\u00e5 snabbt som m\u00f6jligt,&#34; <\/em><strong>s\u00e4ger Nicklas Westerholm, vd f\u00f6r Egetis Therapeutics<\/strong>.<em> &#34;Vi \u00e4r mycket tacksamma mot de patienter, anh\u00f6rigv\u00e5rdare, pr\u00f6vare, kliniker och patientorganisationer vars samarbete och m\u00e5lmedvetenhet m\u00f6jliggjort denna framg\u00e5ng. Jag vill ocks\u00e5 tacka alla Egetis medarbetare och v\u00e5ra samarbetspartners f\u00f6r deras f\u00f6rtr\u00e4ffliga engagemang och h\u00e5rda arbete. Godk\u00e4nnandet markerar ocks\u00e5 en avg\u00f6rande milstolpe f\u00f6r Egetis n\u00e4r vi nu tar n\u00e4sta steg i utvecklingen av l\u00e4kemedel som adresserar allvarliga medicinska behov f\u00f6r patienter med s\u00e4llsynta sjukdomar&#34;.<\/em><\/p>\n<p><em>&#34;Genom min erfarenhet av att v\u00e5rda patienter med MCT8-brist har jag p\u00e5 n\u00e4ra h\u00e5ll sett den djupg\u00e5ende p\u00e5verkan som denna komplexa och livsbegr\u00e4nsande sjukdom kan ha p\u00e5 patienter och deras familjer. Tidig diagnos \u00e4r avg\u00f6rande f\u00f6r att patienterna ska kunna utredas p\u00e5 ett korrekt s\u00e4tt, f\u00e5 kontakt med specialister och f\u00e5 en samordnad multidisciplin\u00e4r v\u00e5rd. FDA:s godk\u00e4nnande av EMCITATE ger l\u00e4kare i USA det f\u00f6rsta godk\u00e4nda behandlingsalternativet f\u00f6r ber\u00e4ttigade patienter och utg\u00f6r ett viktigt framsteg f\u00f6r dem som drabbats,&#34;<\/em> <strong>s\u00e4ger Andrew J. Bauer, M.D.<\/strong>,<strong> <\/strong>pediatrisk endokrinolog, expert p\u00e5 sk\u00f6ldk\u00f6rtelhormonrelaterade sjukdomar samt huvudpr\u00f6vare i ReTRIACt och Triac Trial II, d\u00e4r EMCITATE utv\u00e4rderades i patienter med MCT8-brist.<\/p>\n<p><em>&#34;FDA:s godk\u00e4nnande av EMCITATE \u00e4r en historisk milstolpe f\u00f6r dem som lever med MCT8-brist och ett viktigt steg f\u00f6r att s\u00e4kerst\u00e4lla att patienter f\u00e5r tillg\u00e5ng till behandling. Vi \u00e4r tacksamma mot Egetis samt de forskare, kliniker, patienter, familjer och patientf\u00f6respr\u00e5kare vars engagemang bidrog till att g\u00f6ra denna behandling m\u00f6jlig. Godk\u00e4nnandet \u00e4r ett bevis p\u00e5 vad som \u00e4r m\u00f6jligt n\u00e4r m\u00e4nniskor samlas kring ett gemensamt m\u00e5l om att f\u00f6rb\u00e4ttra v\u00e5rden. Vi ser fram emot att forts\u00e4tta verka f\u00f6r patienternas b\u00e4sta och st\u00f6dja insatser som \u00f6kar medvetenheten om MCT8-brist, f\u00f6rb\u00e4ttrar tillg\u00e5ngen till behandling och ut\u00f6kar behandlingsm\u00f6jligheterna f\u00f6r m\u00e4nniskor som lever med sjukdomen v\u00e4rlden \u00f6ver&#34;, <\/em><strong>s\u00e4ger patientorganisation MCT8-AHDS Foundation i ett uttalande.<\/strong><\/p>\n<p><strong>Lansering av Egetis RareLink\u2122: omfattande patientst\u00f6dsprogram f\u00f6r EMCITATE<\/strong><strong><br \/><\/strong>Egetis \u00e4r engagerat i att hj\u00e4lpa patienter att f\u00e5 snabb tillg\u00e5ng till EMCITATE. Bolaget f\u00f6rv\u00e4ntar sig att EMCITATE blir kommersiellt tillg\u00e4ngligt i USA inom \u00e5tta till tio veckor efter godk\u00e4nnandet. Genom <strong>Egetis RareLink<\/strong>, bolagets dedikerade patientst\u00f6dsprogram, har Egetis etablerat den infrastruktur som kr\u00e4vs f\u00f6r patienttillg\u00e5ng, inklusive specialiserad distribution och dedikerade st\u00f6dresurser, f\u00f6r att s\u00e4kerst\u00e4lla en smidig upplevelse f\u00f6r patienter, anh\u00f6riga och h\u00e4lso- och sjukv\u00e5rdspersonal fr\u00e5n dag ett. Som en del av kommersialiseringsstrategin i USA har Egetis ing\u00e5tt ett samarbete med PANTHERx\u00ae Rare f\u00f6r att st\u00f6dja tillg\u00e5ngen till l\u00e4kemedel, utbildning, v\u00e5rdkoordinering och kontinuerlig behandling.<br \/>F\u00f6r mer information om Egetis RareLink, ring 1-844-4EGETIS (1-844-434-3847).<\/p>\n<p><strong>Priority Review Voucher beviljad<\/strong><strong><br \/><\/strong>I samband med godk\u00e4nnandet av EMCITATE beviljade FDA Egetis en Rare Pediatric Disease Priority Review Voucher (PRV). Bolaget avser att utv\u00e4rdera m\u00f6jligheter att monetarisera PRV:n, vilket potentiellt skulle kunna ske under det fj\u00e4rde kvartalet 2026, f\u00f6rutsatt r\u00e5dande marknadsf\u00f6rh\u00e5llanden.<\/p>\n<p><strong>Telefonkonferens och webbs\u00e4ndning<\/strong><strong><br \/><\/strong>Egetis kommer att h\u00e5lla en telefonkonferens och webbs\u00e4ndning f\u00f6r analytiker och investerare tisdagen den 29 september klockan 8:00 CEST.<br \/>L\u00e4nk till webbs\u00e4ndningen: <a href=\"https:\/\/live.events.inderes.com\/fda-approval-sep-2026\" rel=\"noopener\" target=\"_blank\">https:\/\/live.events.inderes.com\/fda-approval-sep-2026<\/a><br \/>L\u00e4nk till telefonkonferensen: <a href=\"https:\/\/events.inderes.com\/live\/fda-approval-sep-2026\/dial-in\" rel=\"noopener\" target=\"_blank\">https:\/\/events.inderes.com\/live\/fda-approval-sep-2026\/dial-in<\/a><\/p>\n<p>Efter registrering till telefonkonferensen erh\u00e5lls telefonnummer och konferens-ID som ger tillg\u00e5ng till konferensen. Fr\u00e5gor kan st\u00e4llas muntligt via telefonkonferensen. En inspelning av webbs\u00e4ndningen kommer att finnas tillg\u00e4nglig via l\u00e4nken till webbs\u00e4ndningen ovan.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-49727cfc9233\">\n<p><strong class=\"mfn-heading-1\">Om MCT8-brist<\/strong><\/p>\n<hr\/>\n<p>MCT8-brist, \u00e4ven k\u00e4nd som Allan-Herndon-Dudleys syndrom (AHDS), \u00e4r en s\u00e4llsynt, allvarlig och livsf\u00f6rkortande X-kromosombunden sjukdom som orsakas av sjukdomsframkallande mutationer i SLC16A2-genen. Dessa mutationer f\u00f6rs\u00e4mrar funktionen hos MCT8, en viktig transport\u00f6r p\u00e5 cellernas yta som ansvarar f\u00f6r transport av sk\u00f6ldk\u00f6rtelhormon i vissa celler, inklusive i hj\u00e4rnan.<br \/> Som en f\u00f6ljd av detta f\u00e5r patienterna en st\u00f6rd signalering av sk\u00f6ldk\u00f6rtelhormon, k\u00e4nnetecknad av otillr\u00e4cklig aktivitet av sk\u00f6ldk\u00f6rtelhormon i det centrala nervsystemet och \u00f6verexponering f\u00f6r det aktiva sk\u00f6ldk\u00f6rtelhormonet trijodtyronin (T3) i perifera v\u00e4vnader. Detta leder till en komplex sjukdomsbild som pr\u00e4glas av sv\u00e5r neurologisk utvecklingsst\u00f6rning och kvarst\u00e5ende perifer tyreotoxikos.<br \/>De f\u00f6rh\u00f6jda T3-niv\u00e5erna i perifera v\u00e4vnader kan orsaka ett kroniskt hypermetaboliskt tillst\u00e5nd som p\u00e5verkar flera organ, inklusive hj\u00e4rta, muskler, lever och njurar. Kliniska manifestationer kan omfatta otillr\u00e4cklig tillv\u00e4xt, kardiovaskul\u00e4r belastning, muskelf\u00f6rtvining, metabol obalans samt \u00f6kad mottaglighet f\u00f6r infektioner. Dessa systemiska konsekvenser av ih\u00e5llande tyreotoxikos anses bidra v\u00e4sentligt till den \u00f6kade sjukligheten och den f\u00f6rkortade livsl\u00e4ngden som \u00e4r f\u00f6rknippad med sjukdomen. Patienter med MCT8-brist har en rapporterad median\u00f6verlevnad p\u00e5 cirka 35 \u00e5r.<br \/>F\u00f6r mer information om MCT8-brist, bes\u00f6k <a href=\"https:\/\/www.mct8deficiency.eu\/\" rel=\"noopener\" target=\"_blank\">https:\/\/www.mct8deficiency.com<\/a> eller <a href=\"https:\/\/www.lifewithmct8deficiency.com\/\" rel=\"noopener\" target=\"_blank\">https:\/\/www.lifewithmct8deficiency.com\/<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-187dc5d37350\">\n<p><strong class=\"mfn-heading-1\">INDICATION AND USAGE<\/strong><\/p>\n<hr\/>\n<p>EMCITATE is a thyroid hormone receptor agonist indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan\u2013Herndon\u2013Dudley syndrome).<\/p>\n<p>Limitation of use: EMCITATE is not recommended for the treatment of primary hypothyroidism.  <\/p>\n<\/div>\n<div class=\"mfn-footer mfn-d3ec9c09c941\">\n<p><strong class=\"mfn-heading-1\">IMPORTANT SAFETY INFORMATION<\/strong><\/p>\n<hr\/>\n<p><strong>BOXED WARNING<\/strong><br \/>NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS<br \/><strong>\u00a0<\/strong><br \/><strong>CONTRAINDICATIONS<\/strong><br \/>Primary hyperthyroidism<br \/><strong>\u00a0<\/strong><br \/><strong>WARNINGS AND PRECAUTIONS<\/strong><br \/>Thyrotoxicosis: Signs and symptoms of thyrotoxicosis (e.g., increased heart rate, elevated blood pressure, diarrhea, hyperhidrosis, irritability, insomnia, nightmares) have occurred with EMCITATE during treatment initiation and dose titration. Monitor and adjust the EMCITATE dose as indicated.<br \/>Laboratory Test Interference for T3 Measurement: Tiratricol can cross-react with immunoassays for T3 leading to unreliable T3 results and cause an overestimation of T3.<br \/><strong>\u00a0<\/strong><br \/><strong>ADVERSE REACTIONS<\/strong><br \/>Most common adverse reactions (\u2265 5%): diarrhea, vomiting, rash, and hyperhidrosis.<br \/>To report SUSPECTED ADVERSE REACTIONS, contact Egetis Therapeutics US Inc. at 1-844-4EGETIS (1-844-434-3847) or FDA at 1-800-FDA-1088 or <a href=\"http:\/\/www.fda.gov\/medwatch\" rel=\"noopener\" target=\"_blank\">www.fda.gov\/medwatch<\/a>.<br \/>\u00a0<br \/><strong>Please see full Prescribing Information here:<\/strong><br \/><a href=\"https:\/\/www.egetis.com\/wp-content\/uploads\/emcitate-full-prescribing-information.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/www.egetis.com\/wp-content\/uploads\/emcitate-full-prescribing-information.pdf<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-cef580f51688\">\n<p><strong class=\"mfn-heading-1\">Om Egetis Therapeutics<\/strong><\/p>\n<hr\/>\n<p>Egetis Therapeutics \u00e4r ett l\u00e4kemedelsbolag i kommersiell fas med fokus p\u00e5 att utveckla och tillhandah\u00e5lla innovativa behandlingar f\u00f6r patienter med s\u00e4llsynta sjukdomar d\u00e4r det finns betydande medicinska behov. <br \/>Genom att kombinera vetenskaplig och klinisk expertis med integrerade kompetenser inom sen klinisk utveckling, regulatoriska processer, kommersialisering och tillverkning \u00e4r Egetis engagerat i att tillhandah\u00e5lla behandlingar och dedikerat st\u00f6d till patientgrupper med stora medicinska behov och begr\u00e4nsade behandlingsalternativ. <br \/>Bolagets ledande produkt, EMCITATE\u00ae (tiratricol), \u00e4r den f\u00f6rsta och enda godk\u00e4nda behandlingen f\u00f6r MCT8-brist, en s\u00e4llsynt och livsf\u00f6rkortande genetisk sjukdom, med marknadsgodk\u00e4nnande i EU och i USA. <br \/>Med huvudkontor i Stockholm och verksamhet i USA och Europa bygger Egetis ett h\u00e5llbart globalt l\u00e4kemedelsbolag inom s\u00e4llsynta sjukdomar.<br \/>F\u00f6r mer information, bes\u00f6k egetis.com och f\u00f6lj bolaget p\u00e5 LinkedIn.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-21ce51984900\">\n<p><strong class=\"mfn-heading-1\">About PANTHERx Rare<\/strong><\/p>\n<hr\/>\n<p>PANTHERx Rare makes rare disease care more hyper-personalized and less overwhelming by focusing relentlessly on each patient and each therapy. PANTHERx experts develop deep personal relationships with patients, prescribers, and pharmaceutical partners, serving as trusted advocates to ensure seamless collaboration and exceptional care. Since its founding in a garage in Pittsburgh, PA in 2011, PANTHERx has grown into the largest independent rare pharmacy in the U.S., leveraging established-company resources while maintaining small-company responsiveness, innovation, and attention to detail.<br \/> PANTHERx is licensed in all 50 states and U.S. territories and was the first national pharmacy to achieve dual accreditations in rare disease from the Accreditation Commission for Health Care (ACHC) and Utilization Review Accreditation Commission (URAC). PANTHERx is also the nine-time winner of the prestigious MMIT Patient Choice Award for patient satisfaction, including the 2026 honor.<br \/>For more information, please email\u202fTheRareSP@pantherxrare.com\u202for visit www.pantherxrare.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, vd<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<br \/>\u00a0<br \/>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-regulatory mfn-regulatory-mar\">\n<p><em>Denna information \u00e4r s\u00e5dan information som Egetis Therapeutics \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersoners f\u00f6rsorg, f\u00f6r offentligg\u00f6rande den 2026-09-28 23:45 CEST.<\/em><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Fram\u00e5tblickande uttalanden<\/strong><\/p>\n<hr\/>\n<p>Detta pressmeddelande inneh\u00e5ller fram\u00e5tblickande uttalanden i den mening som avses i till\u00e4mplig v\u00e4rdepapperslagstiftning, inklusive uttalanden avseende kommersialiseringen och tillg\u00e4ngligheten av Emcitate\u00ae (tiratricol) i USA, tidpunkten f\u00f6r och utfallet av en eventuell monetisering av Priority Review Voucher f\u00f6r s\u00e4llsynta pediatriska sjukdomar (Rare Pediatric Disease Priority Review Voucher), den f\u00f6rv\u00e4ntade kapaciteten i Bolagets infrastruktur f\u00f6r patient\u00e5tkomst och distribution, de f\u00f6rv\u00e4ntade f\u00f6rdelarna med Emcitate f\u00f6r patienter med MCT8-brist samt Bolagets \u00f6vergripande strategiska planer f\u00f6r utveckling och kommersialisering av behandlingar f\u00f6r s\u00e4llsynta sjukdomar. Fram\u00e5tblickande uttalanden kan i allm\u00e4nhet identifieras genom ord s\u00e5som \u201df\u00f6rv\u00e4ntar\u201d, \u201dbed\u00f6mer\u201d, \u201davser\u201d, \u201danser\u201d, \u201duppskattar\u201d, \u201dplanerar\u201d, \u201dkommer att\u201d, \u201dkan\u201d, \u201dskulle kunna\u201d, \u201dpotentiell\u201d eller liknande uttryck, \u00e4ven om inte alla fram\u00e5tblickande uttalanden inneh\u00e5ller s\u00e5dana ord.<br \/>Dessa uttalanden baseras p\u00e5 Bolagets nuvarande f\u00f6rv\u00e4ntningar, antaganden och bed\u00f6mningar per dagen f\u00f6r detta pressmeddelande och \u00e4r f\u00f6rem\u00e5l f\u00f6r risker, os\u00e4kerhetsfaktorer och andra omst\u00e4ndigheter som kan medf\u00f6ra att faktiska resultat avviker v\u00e4sentligt fr\u00e5n dem som uttryckligen eller underf\u00f6rst\u00e5tt anges i uttalandena. S\u00e5dana faktorer omfattar, men \u00e4r inte begr\u00e4nsade till, risker relaterade till den kommersiella lanseringen av och marknadsacceptansen f\u00f6r Emcitate i USA, Bolagets f\u00f6rm\u00e5ga att etablera och uppr\u00e4tth\u00e5lla en \u00e4ndam\u00e5lsenlig kommersiell infrastruktur, inklusive distributions-, patientst\u00f6ds- och ers\u00e4ttningsl\u00f6sningar, tidpunkten f\u00f6r och villkoren f\u00f6r en eventuell monetisering av Priority Review Voucher, vilken \u00e4r beroende av marknadsf\u00f6rh\u00e5llanden och tillg\u00e5ngen p\u00e5 intresserade k\u00f6pare, eventuella krav eller begr\u00e4nsningar efter marknadsgodk\u00e4nnande som kan komma att inf\u00f6ras av den amerikanska l\u00e4kemedelsmyndigheten FDA, Bolagets f\u00f6rm\u00e5ga att uppr\u00e4tth\u00e5lla regulatoriska godk\u00e4nnanden i USA och Europeiska unionen, konkurrens fr\u00e5n befintliga eller framtida behandlingar, Bolagets m\u00f6jlighet att s\u00e4kerst\u00e4lla tillr\u00e4cklig finansiering f\u00f6r sin verksamhet och sina kommersiella aktiviteter samt allm\u00e4nna ekonomiska, marknadsm\u00e4ssiga och aff\u00e4rsm\u00e4ssiga f\u00f6rh\u00e5llanden.<br \/>F\u00f6r en n\u00e4rmare beskrivning av risker och os\u00e4kerhetsfaktorer som kan p\u00e5verka Bolagets verksamhet och resultat h\u00e4nvisas till Bolagets senaste \u00e5rsredovisning samt \u00f6vriga handlingar som getts in till relevanta tillsynsmyndigheter och som finns tillg\u00e4ngliga p\u00e5 www.egetis.com.<br \/>Bolaget \u00e5tar sig inte n\u00e5gon skyldighet att offentligt uppdatera eller revidera fram\u00e5tblickande uttalanden, vare sig till f\u00f6ljd av ny information, framtida h\u00e4ndelser eller av andra sk\u00e4l, annat \u00e4n vad som f\u00f6ljer av till\u00e4mplig lag eller regelverk.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/e461be8d-a6a9-4939-b4e5-5a9c3324db7c\/egetis-therapeutics-meddelar-att-amerikanska-fda-har-godkant-emcitate-r-tiratricol-for-patienter-med-mct8-brist.pdf\" rel=\"noopener\" target=\"_blank\">Egetis Therapeutics meddelar att amerikanska FDA har godk\u00e4nt EMCITATE\u00ae (tiratricol) f\u00f6r patienter med MCT8-brist<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"F\u00f6rsta och enda FDA-godk\u00e4nda behandlingen av perifer tyreotoxikos hos vuxna och pediatriska patienter med MCT8-brist i USA Egetis lanserar Egetis RareLink\u2122, ett patientst\u00f6dsprogram f\u00f6r EMCITATE, i samarbete med PANTHERx\u00ae Rare FDA har tilldelat Egetis en Rare Pediatric Disease Priority Review Voucher (PRV) i samband med godk\u00e4nnandet Egetis kommer att h\u00e5lla en telefonkonferens och webbs\u00e4ndning f\u00f6r [&hellip;]","protected":false},"template":"","class_list":["post-6477","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-lang-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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The presentations include results from the Triac Trial II and ReTRIACt studies.<\/p>\n<p><strong>ETA Annual Meeting, September 5-8, Porto, Portugal<\/strong><br \/><strong>Title:<\/strong> Effectiveness of early Triac treatment on neurocognitive outcomes in young paediatric male patients with MCT8 deficiency: TRIAC TRIAL II<br \/><strong>Presenter:<\/strong> Floor van der Most, Erasmus Medical Center, Rotterdam, The Netherlands<br \/><strong>Poster presentation:<\/strong> Saturday, September 5, 2026<\/p>\n<p><strong>Title:<\/strong> Effectiveness of early treatment with thyroid hormone analogue TRIAC on neurocognitive outcomes in young paediatric male patients with MCT8 deficiency: an international single arm trial <br \/><strong>Presenter:<\/strong> Floor van der Most, Erasmus Medical Center, Rotterdam, The Netherlands<br \/><strong>Oral presentation:<\/strong> Monday, September 7, 2026, Oral Session 11 (Luis Hall)<br \/><strong><br \/><\/strong><strong>Title<\/strong>: Effects of tiratricol treatment withdrawal in monocarboxylate transporter 8 (MCT8) deficiency: the ReTRIACt trial<br \/><strong>Presenter:<\/strong> Matthijs Freund, Erasmus Medical Center, Rotterdam, The Netherlands<br \/><strong>Oral presentation:<\/strong> Sunday, September 6, 2026, Oral Session 3 (Archive Hall)<\/p>\n<p><strong><br \/><\/strong><strong>ESPE Annual Meeting, September 8-11, Marseille, France<\/strong><br \/><strong>Title:<\/strong> Effects of tiratricol treatment withdrawal in monocarboxylate transporter 8 (MCT8) deficiency: the ReTRIACt trial <br \/><strong>Presenter:<\/strong> Henna Oittinen Corbinelli, Head of Global Medical Affairs, Egetis Therapeutics, Stockholm, Sweden<strong><br \/><\/strong><strong>Poster presentation<\/strong>: Tuesday, September 8, 2026 (Poster ID P1508)<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">For further information, please contact:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, CEO<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com\u00a0<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">About Egetis Therapeutics<\/strong><\/p>\n<hr\/>\n<p>Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.<\/p>\n<p>The Company\u2019s lead drug candidate Emcitate\u00ae (tiratricol) is developed for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate\u00ae as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate\u00ae in Germany on May 1, 2025. EU product information can be accessed via the Summary of Product Characteristics\u00a0found <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/emcitate-epar-product-information_en.pdf\" rel=\"noopener\" target=\"_blank\">here<\/a>.<\/p>\n<p>On March 27, 2026, Egetis announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date, or FDA decision date, of September 28, 2026. Emcitate\u00ae (tiratricol) is not approved in the USA.<\/p>\n<p>The NDA for Emcitate\u00ae (tiratricol) for treatment of MCT8 deficiency is based on clinical data from Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study and the US Expanded Access Program.<\/p>\n<p>Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.<\/p>\n<p>The drug candidate Aladote\u00ae (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb\/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote\u00ae has been parked. Aladote\u00ae has been granted ODD in the US and in the EU.<\/p>\n<p>Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).<br \/>For more information, see <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Forward-looking statements<\/strong><\/p>\n<hr\/>\n<p>This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the commercialization and availability of Emcitate\u00ae (tiratricol) in the United States, the timing and outcome of potential monetization of the Rare Pediatric Disease Priority Review Voucher, the expected capabilities of the Company\u2019s patient access and distribution infrastructure, the anticipated benefits of Emcitate for patients with MCT8 deficiency, and the Company\u2019s broader strategic plans for the development and commercialization of therapies for rare diseases. Forward-looking statements can generally be identified by words such as \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cpotential,\u201d or similar expressions, although not all forward-looking statements contain these words.<br \/>These statements are based on the Company\u2019s current expectations, assumptions, and assessments as of the date of this press release and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to: risks related to the commercial launch and market acceptance of Emcitate in the United States; the ability to establish and maintain adequate commercial infrastructure, including distribution, patient support, and reimbursement arrangements; the timing and terms of any monetization of the Priority Review Voucher, which is subject to market conditions and the availability of interested purchasers; potential post-marketing requirements or restrictions imposed by the FDA; the ability to maintain regulatory approvals in the United States and the European Union; competition from existing or future therapies; the Company\u2019s ability to secure adequate funding for its operations and commercial activities; and general economic, market, and business conditions.<br \/>For a further description of risks and uncertainties that could affect the Company\u2019s business and results, reference is made to the Company\u2019s most recent annual report and other filings with relevant regulatory authorities available at <a href=\"http:\/\/www.egetis.com\/\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or regulation.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Attachments<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/289901fe-d266-4a0f-b797-357722d64413\/emcitate-r-tiratricol-presentations-at-eta-and-espe-congresses-in-september-2026.pdf\" rel=\"noopener\" target=\"_blank\">Emcitate\u00ae (tiratricol) Presentations at ETA and ESPE Congresses in September 2026<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, Sweden, September 4, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that clinical data relating to Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency will be presented at the upcoming 47th Annual Meeting of the European Thyroid Association (ETA) in Porto, Portugal, and at the European Society for [&hellip;]","protected":false},"template":"","class_list":["post-5736","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Emcitate\u00ae (tiratricol) Presentations at ETA and ESPE Congresses in September 2026 - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/emcitate-tiratricol-presentations-at-eta-and-espe-congresses-in-september-2026\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Emcitate\u00ae (tiratricol) Presentations at ETA and ESPE Congresses in September 2026 - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, Sweden, September 4, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that clinical data relating to Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency will be presented at the upcoming 47th Annual Meeting of the European Thyroid Association (ETA) in Porto, Portugal, and at the European Society for [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/emcitate-tiratricol-presentations-at-eta-and-espe-congresses-in-september-2026\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:44+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/emcitate-tiratricol-presentations-at-eta-and-espe-congresses-in-september-2026\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/emcitate-tiratricol-presentations-at-eta-and-espe-congresses-in-september-2026\\\/\",\"name\":\"Emcitate\u00ae (tiratricol) Presentations at ETA and ESPE Congresses in September 2026 - 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Presentationerna inkluderar resultat fr\u00e5n studierna Triac Trial II och ReTRIACt.<\/p>\n<p><strong class=\"mfn-heading-2\">ETA:s \u00e5rskongress, 5\u20138 september, Porto, Portugal<\/strong><\/p>\n<p><strong>Titel:<\/strong> Effectiveness of early Triac treatment on neurocognitive outcomes in young paediatric male patients with MCT8 deficiency: TRIAC TRIAL II<br \/><strong>Presentat\u00f6r:<\/strong> Floor van der Most, Erasmus Medical Center, Rotterdam, Nederl\u00e4nderna<br \/><strong>Posterpresentation:<\/strong> L\u00f6rdag den 5 september 2026<\/p>\n<p><strong>Titel:<\/strong> Effectiveness of early treatment with thyroid hormone analogue TRIAC on neurocognitive outcomes in young paediatric male patients with MCT8 deficiency: an international single arm trial<br \/><strong>Presentat\u00f6r:<\/strong> Floor van der Most, Erasmus Medical Center, Rotterdam, Nederl\u00e4nderna<br \/><strong>Muntlig presentation:<\/strong> M\u00e5ndag den 7 september 2026, Oral Session 11 (Luis Hall)<\/p>\n<p><strong>Titel:<\/strong> Effects of tiratricol treatment withdrawal in monocarboxylate transporter 8 (MCT8) deficiency: the ReTRIACt trial<br \/><strong>Presentat\u00f6r:<\/strong> Matthijs Freund, Erasmus Medical Center, Rotterdam, Nederl\u00e4nderna<br \/><strong>Muntlig presentation:<\/strong> S\u00f6ndag den 6 september 2026, Oral Session 3 (Archive Hall)<\/p>\n<p><strong class=\"mfn-heading-2\">ESPE:s \u00e5rskongress, 8\u201311 september, Marseille, Frankrike<\/strong><\/p>\n<p><strong>Titel:<\/strong> Effects of tiratricol treatment withdrawal in monocarboxylate transporter 8 (MCT8) deficiency: the ReTRIACt trial<br \/><strong>Presentat\u00f6r:<\/strong> Henna Oittinen Corbinelli, Head of Global Medical Affairs, Egetis Therapeutics, Stockholm, Sverige<br \/><strong>Posterpresentation:<\/strong> Tisdag den 8 september 2026 (Poster-ID P1508)<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, vd<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<br \/>\u00a0<br \/>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">Om Egetis Therapeutics AB<\/strong><\/p>\n<hr\/>\n<p>Egetis \u00e4r ett innovativt och integrerat l\u00e4kemedelsbolag, fokuserat p\u00e5 projekt i sen klinisk utvecklingsfas och kommersialisering inom s\u00e4rl\u00e4kemedelsomr\u00e5det f\u00f6r behandling av allvarliga och s\u00e4llsynta sjukdomar med betydande medicinska behov.<\/p>\n<p>Bolagets ledande l\u00e4kemedelskandidat Emcitate\u00ae (tiratrikol) har utvecklats som den f\u00f6rsta och enda godk\u00e4nda behandlingen f\u00f6r patienter med MCT8-brist, en s\u00e4llsynt sjukdom med ett stort medicinskt behov. Egetis erh\u00f6ll marknadsgodk\u00e4nnande f\u00f6r Emcitate\u00ae \u00a0i EU i februari 2025 som den f\u00f6rsta och enda behandlingen f\u00f6r MCT8-brist. Egetis inledde lanseringen av Emcitate\u00ae \u00a0i Tyskland den 1 maj 2025. EU produktinformation kan f\u00e5s via produktresum\u00e9n <a href=\"https:\/\/www.ema.europa.eu\/sv\/documents\/product-information\/emcitate-epar-product-information_sv.pdf\" rel=\"noopener\" target=\"_blank\">h\u00e4r<\/a>.<\/p>\n<p>Den 27 mars 2026 meddelade Egetis att FDA har accepterat Bolagets NDA f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8\u2011brist. Ans\u00f6kan har beviljats prioriterad granskning (Priority Review) och tilldelats ett m\u00e5ldatum enligt Prescription Drug User Fee Act (PDUFA), vilket utg\u00f6r FDA:s beslutsdatum, den 28 september 2026. Emcitate\u00ae (tiratricol) \u00e4r inte godk\u00e4nd i USA.<\/p>\n<p>NDA:n f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist baseras p\u00e5 kliniska data fr\u00e5n Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study och det amerikanska Expanded Access-programmet.<\/p>\n<p>Tiratrikol har s\u00e4rl\u00e4kemedelsstatus (\u2019orphan drug designation\u2019, ODD) i USA och EU f\u00f6r MCT8-brist och RTH-beta. MCT8-brist och RTH-beta \u00e4r separata indikationer med distinkta patientpopulationer. I USA har Emcitate \u00e4ven beviljats Breakthrough Therapy Designation och Rare Pediatric Disease Designation (RPDD), vilket ger Egetis m\u00f6jligheten att erh\u00e5lla en Priority Review Voucher (PRV), efter marknadsgodk\u00e4nnande. I UK har Emcitate erh\u00e5llit Promising Innovative Medicine status av den brittiska l\u00e4kemedelsmyndigheten MHRA.<\/p>\n<p>Aladote\u00ae (calmangafodipir) \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att reducera risken f\u00f6r akuta leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. En \u201dproof of principle\u201d-studie har framg\u00e5ngsrikt avslutats och utformningen av en registreringsgrundande fas 2\/3 studie, Albatross, med syfte att ans\u00f6ka om marknadsgodk\u00e4nnande i USA och Europa har slutf\u00f6rts efter diskussioner med l\u00e4kemedelsmyndigheterna i USA, EU och Storbritannien. Utvecklingsprogrammet f\u00f6r Aladote\u00ae \u00a0har parkerats. Aladote\u00ae \u00a0har beviljats ODD i USA och EU.<\/p>\n<p>Egetis Therapeutics \u00e4r noterad p\u00e5 Nasdaq Stockholms huvudlista (Nasdaq Stockholm: EGTX) .<br \/>F\u00f6r mer information, se <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Fram\u00e5tblickande uttalanden<\/strong><\/p>\n<hr\/>\n<p>Detta pressmeddelande inneh\u00e5ller fram\u00e5tblickande uttalanden i den mening som avses i till\u00e4mplig v\u00e4rdepapperslagstiftning, inklusive uttalanden avseende kommersialiseringen och tillg\u00e4ngligheten av Emcitate\u00ae (tiratricol) i USA, tidpunkten f\u00f6r och utfallet av en eventuell monetisering av Priority Review Voucher f\u00f6r s\u00e4llsynta pediatriska sjukdomar (Rare Pediatric Disease Priority Review Voucher), den f\u00f6rv\u00e4ntade kapaciteten i Bolagets infrastruktur f\u00f6r patient\u00e5tkomst och distribution, de f\u00f6rv\u00e4ntade f\u00f6rdelarna med Emcitate f\u00f6r patienter med MCT8-brist samt Bolagets \u00f6vergripande strategiska planer f\u00f6r utveckling och kommersialisering av behandlingar f\u00f6r s\u00e4llsynta sjukdomar. Fram\u00e5tblickande uttalanden kan i allm\u00e4nhet identifieras genom ord s\u00e5som \u201df\u00f6rv\u00e4ntar\u201d, \u201dbed\u00f6mer\u201d, \u201davser\u201d, \u201danser\u201d, \u201duppskattar\u201d, \u201dplanerar\u201d, \u201dkommer att\u201d, \u201dkan\u201d, \u201dskulle kunna\u201d, \u201dpotentiell\u201d eller liknande uttryck, \u00e4ven om inte alla fram\u00e5tblickande uttalanden inneh\u00e5ller s\u00e5dana ord.<br \/>Dessa uttalanden baseras p\u00e5 Bolagets nuvarande f\u00f6rv\u00e4ntningar, antaganden och bed\u00f6mningar per dagen f\u00f6r detta pressmeddelande och \u00e4r f\u00f6rem\u00e5l f\u00f6r risker, os\u00e4kerhetsfaktorer och andra omst\u00e4ndigheter som kan medf\u00f6ra att faktiska resultat avviker v\u00e4sentligt fr\u00e5n dem som uttryckligen eller underf\u00f6rst\u00e5tt anges i uttalandena. S\u00e5dana faktorer omfattar, men \u00e4r inte begr\u00e4nsade till, risker relaterade till den kommersiella lanseringen av och marknadsacceptansen f\u00f6r Emcitate i USA, Bolagets f\u00f6rm\u00e5ga att etablera och uppr\u00e4tth\u00e5lla en \u00e4ndam\u00e5lsenlig kommersiell infrastruktur, inklusive distributions-, patientst\u00f6ds- och ers\u00e4ttningsl\u00f6sningar, tidpunkten f\u00f6r och villkoren f\u00f6r en eventuell monetisering av Priority Review Voucher, vilken \u00e4r beroende av marknadsf\u00f6rh\u00e5llanden och tillg\u00e5ngen p\u00e5 intresserade k\u00f6pare, eventuella krav eller begr\u00e4nsningar efter marknadsgodk\u00e4nnande som kan komma att inf\u00f6ras av den amerikanska l\u00e4kemedelsmyndigheten FDA, Bolagets f\u00f6rm\u00e5ga att uppr\u00e4tth\u00e5lla regulatoriska godk\u00e4nnanden i USA och Europeiska unionen, konkurrens fr\u00e5n befintliga eller framtida behandlingar, Bolagets m\u00f6jlighet att s\u00e4kerst\u00e4lla tillr\u00e4cklig finansiering f\u00f6r sin verksamhet och sina kommersiella aktiviteter samt allm\u00e4nna ekonomiska, marknadsm\u00e4ssiga och aff\u00e4rsm\u00e4ssiga f\u00f6rh\u00e5llanden.<br \/>F\u00f6r en n\u00e4rmare beskrivning av risker och os\u00e4kerhetsfaktorer som kan p\u00e5verka Bolagets verksamhet och resultat h\u00e4nvisas till Bolagets senaste \u00e5rsredovisning samt \u00f6vriga handlingar som getts in till relevanta tillsynsmyndigheter och som finns tillg\u00e4ngliga p\u00e5 www.egetis.com.<br \/>Bolaget \u00e5tar sig inte n\u00e5gon skyldighet att offentligt uppdatera eller revidera fram\u00e5tblickande uttalanden, vare sig till f\u00f6ljd av ny information, framtida h\u00e4ndelser eller av andra sk\u00e4l, annat \u00e4n vad som f\u00f6ljer av till\u00e4mplig lag eller regelverk.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/da04f985-9729-49a4-9481-0c046faaf054\/presentationer-om-emcitate-r-tiratrikol-vid-eta-s-och-espe-s-kongresser-i-september-2026.pdf\" rel=\"noopener\" target=\"_blank\">Presentationer om Emcitate\u00ae (tiratrikol) vid ETA:s och ESPE:s kongresser i september 2026<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, den 4 september 2026. Egetis Therapeutics AB (publ) (\u201dEgetis\u201d eller \u201dBolaget\u201d) (Nasdaq Stockholm: EGTX) meddelade idag att kliniska data avseende Emcitate\u00ae (tiratrikol) f\u00f6r behandling av MCT8-brist kommer att presenteras vid den kommande 47:e \u00e5rskongressen f\u00f6r European Thyroid Association (ETA) i Porto, Portugal, samt vid European Society for Paediatric Endocrinologys (ESPE) 64:e \u00e5rskongress i Marseille, [&hellip;]","protected":false},"template":"","class_list":["post-5737","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn-lang-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Presentationer om Emcitate\u00ae (tiratrikol) vid ETA:s och ESPE:s kongresser i september 2026 - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/presentationer-om-emcitate-tiratrikol-vid-etas-och-espes-kongresser-i-september-2026\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Presentationer om Emcitate\u00ae (tiratrikol) vid ETA:s och ESPE:s kongresser i september 2026 - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, den 4 september 2026. Egetis Therapeutics AB (publ) (\u201dEgetis\u201d eller \u201dBolaget\u201d) (Nasdaq Stockholm: EGTX) meddelade idag att kliniska data avseende Emcitate\u00ae (tiratrikol) f\u00f6r behandling av MCT8-brist kommer att presenteras vid den kommande 47:e \u00e5rskongressen f\u00f6r European Thyroid Association (ETA) i Porto, Portugal, samt vid European Society for Paediatric Endocrinologys (ESPE) 64:e \u00e5rskongress i Marseille, [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/presentationer-om-emcitate-tiratrikol-vid-etas-och-espes-kongresser-i-september-2026\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:44+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/presentationer-om-emcitate-tiratrikol-vid-etas-och-espes-kongresser-i-september-2026\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/presentationer-om-emcitate-tiratrikol-vid-etas-och-espes-kongresser-i-september-2026\\\/\",\"name\":\"Presentationer om Emcitate\u00ae (tiratrikol) vid ETA:s och ESPE:s kongresser i september 2026 - 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(GLOBE NEWSWIRE) <\/strong>Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX) today announced that it will participate in upcoming investor conferences in September.\u00a0<\/p>\n<p><strong>Cantor Global Healthcare Conference 2026<\/strong><br \/>Date: Friday, September 11, 2026<br \/>Location: Waldorf Astoria, New York<br \/>Format: Fireside chat and 1-1 meetings <br \/>Nicklas Westerholm, CEO, will participate in a fireside chat, 9:10-9:40 a.m. EDT (15:10-15:40 CEST).<\/p>\n<p>A live webcast and replay will be available via this <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=YmgIuWQJP1ggrYgZu_HFfqWg9dd4yaETaGXqd1ujA9jA7JreK0wEKhzCebAp9CHWKF6M-_iCIgSjix8yQSNinqTp2BscwKjGr2R6XnhyU0_v_BpuCFhaTI3snJjq9rdobE7rk04seC7SHPlTChLk4VtPQQ7odicWab6Ou_D2pNrBO8ZduHS3J5hUneS22aL96f1Ll64t905E4hTBgNgx7xQGcsXNMUV0SuUsZbVK0RiJ7p6f90uva5qpDpIWAwXr\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>LINK<\/b><\/a>.<\/p>\n<p><strong>Morgan Stanley 24th Annual Global Healthcare Conference\u00a02026<\/strong><br \/>Date: Wednesday, September 16, 2026<br \/>Location: New York Marriott Marquis, New York<br \/>Format: Fireside chat and 1-1 meetings <br \/>Nicklas Westerholm, CEO, will participate in a fireside chat, 1:50-2:20 p.m. EDT (19:50-20:20 CEST).<\/p>\n<p>A live webcast and replay will be available via this <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=YmgIuWQJP1ggrYgZu_HFfutUXdqgnMC55KDTA4MLaoCLhDiwEmnFEQau4-vKci6n8oMjZhVFCla47LAMyuztHcKcy1r6aUgdA_iZAoAEnWWm-ML7U7O3u-e7NuakWDc5\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>LINK<\/b><\/a><b>.<\/b><\/p>\n<hr\/>\n<p><strong>For further information, please contact:<\/strong><\/p>\n<p>Nicklas Westerholm, CEO<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com\u00a0<\/p>\n<hr\/>\n<p><strong>About Egetis Therapeutics<\/strong><\/p>\n<p>Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.<\/p>\n<p>The Company\u2019s lead drug candidate Emcitate\u00ae (tiratricol) is developed for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate\u00ae as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate\u00ae in Germany on May 1, 2025. EU product information can be accessed via the Summary of Product Characteristics\u00a0found\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=cAqHr5k9Pw3nVsgNrUshSF0fZyk2_fOktYdYizW1odKfwdzNtQquO3BBbrZxbNZwQuUqP8F01rotwiTW_vA6M8ZIhHpdglV1If41GHQfZNt0U7oord_4Zc-rjuMrCWFwsLSwJjbecfvJi144xyTq0tdY6G2xcINmiTNYTN0WGbjtFj8VyhRX1-t00j6XjsBo\" rel=\"nofollow noopener\" target=\"_blank\" title=\"here\">here<\/a>.<\/p>\n<p>On March 27, 2026, Egetis announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date, or FDA decision date, of September 28, 2026. Emcitate\u00ae (tiratricol) is not approved in the USA.<\/p>\n<p>The NDA for Emcitate\u00ae (tiratricol) for treatment of MCT8 deficiency is based on clinical data from Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study and the US Expanded Access Program.<\/p>\n<p>Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.<\/p>\n<p>The drug candidate Aladote\u00ae (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb\/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote\u00ae has been parked. Aladote\u00ae has been granted ODD in the US and in the EU.<\/p>\n<p>Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).<br \/>For more information, see\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gl7lHbEF-oleZA6--g8pmiWBwK3oLtlIBsYVFF_z-2FChOgho9O71Pgg_CCv7Gqgi_mnAThomZLj6b2QNDwgbkHvDraJphhn5jbqmVRUxWY=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"www.egetis.com\">www.egetis.com<\/a><\/p>\n<hr\/>\n<p><strong>Forward-looking statements<\/strong><\/p>\n<p>This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the commercialization and availability of Emcitate\u00ae (tiratricol) in the United States, the timing and outcome of potential monetization of the Rare Pediatric Disease Priority Review Voucher, the expected capabilities of the Company\u2019s patient access and distribution infrastructure, the anticipated benefits of Emcitate for patients with MCT8 deficiency, and the Company\u2019s broader strategic plans for the development and commercialization of therapies for rare diseases. Forward-looking statements can generally be identified by words such as \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cpotential,\u201d or similar expressions, although not all forward-looking statements contain these words.<br \/>These statements are based on the Company\u2019s current expectations, assumptions, and assessments as of the date of this press release and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to: risks related to the commercial launch and market acceptance of Emcitate in the United States; the ability to establish and maintain adequate commercial infrastructure, including distribution, patient support, and reimbursement arrangements; the timing and terms of any monetization of the Priority Review Voucher, which is subject to market conditions and the availability of interested purchasers; potential post-marketing requirements or restrictions imposed by the FDA; the ability to maintain regulatory approvals in the United States and the European Union; competition from existing or future therapies; the Company\u2019s ability to secure adequate funding for its operations and commercial activities; and general economic, market, and business conditions.<br \/>For a further description of risks and uncertainties that could affect the Company\u2019s business and results, reference is made to the Company\u2019s most recent annual report and other filings with relevant regulatory authorities available at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gl7lHbEF-oleZA6--g8pmji5OXmjLZXZ5cY4UrRws8rK8rIuU6yOixPU8mhMVVQyOmNvHto4HLUDXdBAcExNXXp3L3apfJteXmWKOmWxeFQ=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"www.egetis.com\">www.egetis.com<\/a>. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or regulation.<\/p>\n<p>\n            <\/div>\n","protected":false},"excerpt":{"rendered":"STOCKHOLM, SWEDEN, Sept. 03, 2026. (GLOBE NEWSWIRE) Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX) today announced that it will participate in upcoming investor conferences in September.\u00a0 Cantor Global Healthcare Conference 2026Date: Friday, September 11, 2026Location: Waldorf Astoria, New YorkFormat: Fireside chat and 1-1 meetings Nicklas Westerholm, CEO, will participate in a [&hellip;]","protected":false},"template":"","class_list":["post-5738","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-ci-calendar","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"STOCKHOLM, SWEDEN, Sept. 03, 2026. (GLOBE NEWSWIRE) Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX) today announced that it will participate in upcoming investor conferences in September.\u00a0 Cantor Global Healthcare Conference 2026Date: Friday, September 11, 2026Location: Waldorf Astoria, New YorkFormat: Fireside chat and 1-1 meetings Nicklas Westerholm, CEO, will participate in a [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:44+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september\\\/\",\"name\":\"Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - 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Therapeutics to Participate in Upcoming Investor Conferences in September"},"content":{"rendered":"<div class=\"mfn-body\">\n<p><strong>Stockholm, Sweden, September 3, 2026.<\/strong> Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that it will participate in upcoming investor conferences in September.<\/p>\n<p><em>Cantor Global Healthcare Conference 2026<\/em><br \/>Date: Friday, September 11, 2026<br \/>Location: Waldorf Astoria, New York<br \/>Format: Fireside chat and 1-1 meetings <br \/>Nicklas Westerholm, CEO, will participate in a fireside chat, 9:10-9:40 a.m. EDT (15:10-15:40 CEST).<\/p>\n<p>A live webcast and replay will be available via this <strong><a href=\"https:\/\/sqps.onstreamsecure.com\/origin\/enliven\/players\/EnlivenPlayer.html?customerId=22&amp;eventId=98105418&amp;checkCompany=1&amp;checkEmail=1&amp;checkName=1\" rel=\"noopener\" target=\"_blank\">LINK<\/a><\/strong>.<\/p>\n<p><em>Morgan Stanley 24th Annual Global Healthcare Conference\u00a02026<\/em><br \/>Date: Wednesday, September 16, 2026<br \/>Location: New York Marriott Marquis, New York<br \/>Format: Fireside chat and 1-1 meetings <br \/>Nicklas Westerholm, CEO, will participate in a fireside chat, 1:50-2:20 p.m. EDT (19:50-20:20 CEST).<\/p>\n<p>A live webcast and replay will be available via this <strong><a href=\"https:\/\/cc.webcasts.com\/morg007\/091426a_js\/?entity=168_STD28LB\" rel=\"noopener\" target=\"_blank\">LINK<\/a><\/strong><strong>.<\/strong><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">For further information, please contact:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, CEO<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com\u00a0<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">About Egetis Therapeutics<\/strong><\/p>\n<hr\/>\n<p>Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.<\/p>\n<p>The Company\u2019s lead drug candidate Emcitate\u00ae (tiratricol) is developed for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate\u00ae as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate\u00ae in Germany on May 1, 2025. EU product information can be accessed via the Summary of Product Characteristics\u00a0found <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/emcitate-epar-product-information_en.pdf\" rel=\"noopener\" target=\"_blank\">here<\/a>.<\/p>\n<p>On March 27, 2026, Egetis announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date, or FDA decision date, of September 28, 2026. Emcitate\u00ae (tiratricol) is not approved in the USA.<\/p>\n<p>The NDA for Emcitate\u00ae (tiratricol) for treatment of MCT8 deficiency is based on clinical data from Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study and the US Expanded Access Program.<\/p>\n<p>Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.<\/p>\n<p>The drug candidate Aladote\u00ae (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb\/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote\u00ae has been parked. Aladote\u00ae has been granted ODD in the US and in the EU.<\/p>\n<p>Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).<br \/>For more information, see <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Forward-looking statements<\/strong><\/p>\n<hr\/>\n<p>This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the commercialization and availability of Emcitate\u00ae (tiratricol) in the United States, the timing and outcome of potential monetization of the Rare Pediatric Disease Priority Review Voucher, the expected capabilities of the Company\u2019s patient access and distribution infrastructure, the anticipated benefits of Emcitate for patients with MCT8 deficiency, and the Company\u2019s broader strategic plans for the development and commercialization of therapies for rare diseases. Forward-looking statements can generally be identified by words such as \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cpotential,\u201d or similar expressions, although not all forward-looking statements contain these words.<br \/>These statements are based on the Company\u2019s current expectations, assumptions, and assessments as of the date of this press release and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to: risks related to the commercial launch and market acceptance of Emcitate in the United States; the ability to establish and maintain adequate commercial infrastructure, including distribution, patient support, and reimbursement arrangements; the timing and terms of any monetization of the Priority Review Voucher, which is subject to market conditions and the availability of interested purchasers; potential post-marketing requirements or restrictions imposed by the FDA; the ability to maintain regulatory approvals in the United States and the European Union; competition from existing or future therapies; the Company\u2019s ability to secure adequate funding for its operations and commercial activities; and general economic, market, and business conditions.<br \/>For a further description of risks and uncertainties that could affect the Company\u2019s business and results, reference is made to the Company\u2019s most recent annual report and other filings with relevant regulatory authorities available at <a href=\"http:\/\/www.egetis.com\/\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or regulation.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Attachments<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/32f7abde-1bf0-455d-9fdc-30e895249a8f\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september.pdf\" rel=\"noopener\" target=\"_blank\">Egetis Therapeutics to Participate in Upcoming Investor Conferences in September<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, Sweden, September 3, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that it will participate in upcoming investor conferences in September. Cantor Global Healthcare Conference 2026Date: Friday, September 11, 2026Location: Waldorf Astoria, New YorkFormat: Fireside chat and 1-1 meetings Nicklas Westerholm, CEO, will participate in a fireside chat, [&hellip;]","protected":false},"template":"","class_list":["post-5739","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september-2\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, Sweden, September 3, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that it will participate in upcoming investor conferences in September. Cantor Global Healthcare Conference 2026Date: Friday, September 11, 2026Location: Waldorf Astoria, New YorkFormat: Fireside chat and 1-1 meetings Nicklas Westerholm, CEO, will participate in a fireside chat, [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september-2\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:45+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september-2\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/egetis-therapeutics-to-participate-in-upcoming-investor-conferences-in-september-2\\\/\",\"name\":\"Egetis Therapeutics to Participate in Upcoming Investor Conferences in September - 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eller &#34;Bolaget&#34;) (Nasdaq Stockholm: EGTX) meddelade idag att Bolaget kommer att delta vid kommande investerarkonferenser i september.<\/p>\n<p><em>Cantor Global Healthcare Conference 2026<\/em><br \/>Datum: Fredag den 11 september 2026<br \/>Plats: Waldorf Astoria, New York<br \/>Format: Fireside chat och enskilda investerarm\u00f6ten (1-on-1)<br \/>Nicklas Westerholm, vd, kommer att delta i en fireside chat mellan kl. 09:10 och 09.40 EDT (15:10\u201315:40 CEST).<\/p>\n<p>En direkts\u00e4nd webbs\u00e4ndning samt en inspelad version kommer att finnas tillg\u00e4ngliga via denna <strong><a href=\"https:\/\/sqps.onstreamsecure.com\/origin\/enliven\/players\/EnlivenPlayer.html?customerId=22&amp;eventId=98105418&amp;checkCompany=1&amp;checkEmail=1&amp;checkName=1\" rel=\"noopener\" target=\"_blank\">L\u00c4NK.<\/a><\/strong><\/p>\n<p><em>Morgan Stanley 24th Annual Global Healthcare Conference 2026<\/em><br \/>Datum: Onsdag den 16 september 2026<br \/>Plats: New York Marriott Marquis, New York<br \/>Format: Fireside chat och enskilda investerarm\u00f6ten (1-on-1)<br \/>Nicklas Westerholm, vd, kommer att delta i en fireside chat mellan kl. 13:50 och 14:20 EDT (19:50\u201320:20 CEST).<\/p>\n<p>En direkts\u00e4nd webbs\u00e4ndning samt en inspelad version kommer att finnas tillg\u00e4ngliga via denna <strong><a href=\"https:\/\/cc.webcasts.com\/morg007\/091426a_js\/?entity=168_STD28LB\" rel=\"noopener\" target=\"_blank\">L\u00c4NK<\/a><\/strong><strong>.<\/strong><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, vd<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<br \/>\u00a0<br \/>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">Om Egetis Therapeutics AB<\/strong><\/p>\n<hr\/>\n<p>Egetis \u00e4r ett innovativt och integrerat l\u00e4kemedelsbolag, fokuserat p\u00e5 projekt i sen klinisk utvecklingsfas och kommersialisering inom s\u00e4rl\u00e4kemedelsomr\u00e5det f\u00f6r behandling av allvarliga och s\u00e4llsynta sjukdomar med betydande medicinska behov.<\/p>\n<p>Bolagets ledande l\u00e4kemedelskandidat Emcitate\u00ae (tiratrikol) har utvecklats som den f\u00f6rsta och enda godk\u00e4nda behandlingen f\u00f6r patienter med MCT8-brist, en s\u00e4llsynt sjukdom med ett stort medicinskt behov. Egetis erh\u00f6ll marknadsgodk\u00e4nnande f\u00f6r Emcitate\u00ae \u00a0i EU i februari 2025 som den f\u00f6rsta och enda behandlingen f\u00f6r MCT8-brist. Egetis inledde lanseringen av Emcitate\u00ae \u00a0i Tyskland den 1 maj 2025. EU produktinformation kan f\u00e5s via produktresum\u00e9n <a href=\"https:\/\/www.ema.europa.eu\/sv\/documents\/product-information\/emcitate-epar-product-information_sv.pdf\" rel=\"noopener\" target=\"_blank\">h\u00e4r<\/a>.<\/p>\n<p>Den 27 mars 2026 meddelade Egetis att FDA har accepterat Bolagets NDA f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8\u2011brist. Ans\u00f6kan har beviljats prioriterad granskning (Priority Review) och tilldelats ett m\u00e5ldatum enligt Prescription Drug User Fee Act (PDUFA), vilket utg\u00f6r FDA:s beslutsdatum, den 28 september 2026. Emcitate\u00ae (tiratricol) \u00e4r inte godk\u00e4nd i USA.<\/p>\n<p>NDA:n f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist baseras p\u00e5 kliniska data fr\u00e5n Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study och det amerikanska Expanded Access-programmet.<\/p>\n<p>Tiratrikol har s\u00e4rl\u00e4kemedelsstatus (\u2019orphan drug designation\u2019, ODD) i USA och EU f\u00f6r MCT8-brist och RTH-beta. MCT8-brist och RTH-beta \u00e4r separata indikationer med distinkta patientpopulationer. I USA har Emcitate \u00e4ven beviljats Breakthrough Therapy Designation och Rare Pediatric Disease Designation (RPDD), vilket ger Egetis m\u00f6jligheten att erh\u00e5lla en Priority Review Voucher (PRV), efter marknadsgodk\u00e4nnande. I UK har Emcitate erh\u00e5llit Promising Innovative Medicine status av den brittiska l\u00e4kemedelsmyndigheten MHRA.<\/p>\n<p>Aladote\u00ae (calmangafodipir) \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att reducera risken f\u00f6r akuta leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. En \u201dproof of principle\u201d-studie har framg\u00e5ngsrikt avslutats och utformningen av en registreringsgrundande fas 2\/3 studie, Albatross, med syfte att ans\u00f6ka om marknadsgodk\u00e4nnande i USA och Europa har slutf\u00f6rts efter diskussioner med l\u00e4kemedelsmyndigheterna i USA, EU och Storbritannien. Utvecklingsprogrammet f\u00f6r Aladote\u00ae \u00a0har parkerats. Aladote\u00ae \u00a0har beviljats ODD i USA och EU.<\/p>\n<p>Egetis Therapeutics \u00e4r noterad p\u00e5 Nasdaq Stockholms huvudlista (Nasdaq Stockholm: EGTX) .<br \/>F\u00f6r mer information, se <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Fram\u00e5tblickande uttalanden<\/strong><\/p>\n<hr\/>\n<p>Detta pressmeddelande inneh\u00e5ller fram\u00e5tblickande uttalanden i den mening som avses i till\u00e4mplig v\u00e4rdepapperslagstiftning, inklusive uttalanden avseende kommersialiseringen och tillg\u00e4ngligheten av Emcitate\u00ae (tiratricol) i USA, tidpunkten f\u00f6r och utfallet av en eventuell monetisering av Priority Review Voucher f\u00f6r s\u00e4llsynta pediatriska sjukdomar (Rare Pediatric Disease Priority Review Voucher), den f\u00f6rv\u00e4ntade kapaciteten i Bolagets infrastruktur f\u00f6r patient\u00e5tkomst och distribution, de f\u00f6rv\u00e4ntade f\u00f6rdelarna med Emcitate f\u00f6r patienter med MCT8-brist samt Bolagets \u00f6vergripande strategiska planer f\u00f6r utveckling och kommersialisering av behandlingar f\u00f6r s\u00e4llsynta sjukdomar. Fram\u00e5tblickande uttalanden kan i allm\u00e4nhet identifieras genom ord s\u00e5som \u201df\u00f6rv\u00e4ntar\u201d, \u201dbed\u00f6mer\u201d, \u201davser\u201d, \u201danser\u201d, \u201duppskattar\u201d, \u201dplanerar\u201d, \u201dkommer att\u201d, \u201dkan\u201d, \u201dskulle kunna\u201d, \u201dpotentiell\u201d eller liknande uttryck, \u00e4ven om inte alla fram\u00e5tblickande uttalanden inneh\u00e5ller s\u00e5dana ord.<br \/>Dessa uttalanden baseras p\u00e5 Bolagets nuvarande f\u00f6rv\u00e4ntningar, antaganden och bed\u00f6mningar per dagen f\u00f6r detta pressmeddelande och \u00e4r f\u00f6rem\u00e5l f\u00f6r risker, os\u00e4kerhetsfaktorer och andra omst\u00e4ndigheter som kan medf\u00f6ra att faktiska resultat avviker v\u00e4sentligt fr\u00e5n dem som uttryckligen eller underf\u00f6rst\u00e5tt anges i uttalandena. S\u00e5dana faktorer omfattar, men \u00e4r inte begr\u00e4nsade till, risker relaterade till den kommersiella lanseringen av och marknadsacceptansen f\u00f6r Emcitate i USA, Bolagets f\u00f6rm\u00e5ga att etablera och uppr\u00e4tth\u00e5lla en \u00e4ndam\u00e5lsenlig kommersiell infrastruktur, inklusive distributions-, patientst\u00f6ds- och ers\u00e4ttningsl\u00f6sningar, tidpunkten f\u00f6r och villkoren f\u00f6r en eventuell monetisering av Priority Review Voucher, vilken \u00e4r beroende av marknadsf\u00f6rh\u00e5llanden och tillg\u00e5ngen p\u00e5 intresserade k\u00f6pare, eventuella krav eller begr\u00e4nsningar efter marknadsgodk\u00e4nnande som kan komma att inf\u00f6ras av den amerikanska l\u00e4kemedelsmyndigheten FDA, Bolagets f\u00f6rm\u00e5ga att uppr\u00e4tth\u00e5lla regulatoriska godk\u00e4nnanden i USA och Europeiska unionen, konkurrens fr\u00e5n befintliga eller framtida behandlingar, Bolagets m\u00f6jlighet att s\u00e4kerst\u00e4lla tillr\u00e4cklig finansiering f\u00f6r sin verksamhet och sina kommersiella aktiviteter samt allm\u00e4nna ekonomiska, marknadsm\u00e4ssiga och aff\u00e4rsm\u00e4ssiga f\u00f6rh\u00e5llanden.<br \/>F\u00f6r en n\u00e4rmare beskrivning av risker och os\u00e4kerhetsfaktorer som kan p\u00e5verka Bolagets verksamhet och resultat h\u00e4nvisas till Bolagets senaste \u00e5rsredovisning samt \u00f6vriga handlingar som getts in till relevanta tillsynsmyndigheter och som finns tillg\u00e4ngliga p\u00e5 www.egetis.com.<br \/>Bolaget \u00e5tar sig inte n\u00e5gon skyldighet att offentligt uppdatera eller revidera fram\u00e5tblickande uttalanden, vare sig till f\u00f6ljd av ny information, framtida h\u00e4ndelser eller av andra sk\u00e4l, annat \u00e4n vad som f\u00f6ljer av till\u00e4mplig lag eller regelverk.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/4ddc4177-58a2-46f8-949c-4fbb43431729\/egetis-therapeutics-deltar-i-kommande-investerarkonferenser-i-september.pdf\" rel=\"noopener\" target=\"_blank\">Egetis Therapeutics deltar i kommande investerarkonferenser i september<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, 3 september, 2026. Egetis Therapeutics AB (publ) (&#34;Egetis&#34; eller &#34;Bolaget&#34;) (Nasdaq Stockholm: EGTX) meddelade idag att Bolaget kommer att delta vid kommande investerarkonferenser i september. Cantor Global Healthcare Conference 2026Datum: Fredag den 11 september 2026Plats: Waldorf Astoria, New YorkFormat: Fireside chat och enskilda investerarm\u00f6ten (1-on-1)Nicklas Westerholm, vd, kommer att delta i en fireside chat [&hellip;]","protected":false},"template":"","class_list":["post-5740","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn-lang-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Egetis Therapeutics deltar i kommande investerarkonferenser i september - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/egetis-therapeutics-deltar-i-kommande-investerarkonferenser-i-september\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Egetis Therapeutics deltar i kommande investerarkonferenser i september - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 3 september, 2026. 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Granted Orphan Drug Designation for MCT8 Deficiency in Japan"},"content":{"rendered":"<div class=\"mfn-body\">\n<p><strong>Stockholm, Sweden, August 31, 2026.<\/strong> Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency in Japan, has been granted Orphan Drug Designation (ODD) for tiratricol for MCT8 deficiency by the Ministry of Health, Labour and Welfare (MHLW).<\/p>\n<p>One of the benefits of ODD in Japan is that a marketing authorization application is eligible for Priority Review, reducing the review time from approximately twelve to nine months and an extension of the market exclusivity period to ten years.<\/p>\n<p>Emcitate (tiratricol) also holds ODD for MCT8 deficiency in the US and EU.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">For further information, please contact:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, CEO<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com\u00a0<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">About Egetis Therapeutics<\/strong><\/p>\n<hr\/>\n<p>Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.<\/p>\n<p>The Company\u2019s lead drug candidate Emcitate\u00ae (tiratricol) is developed for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate\u00ae as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate\u00ae in Germany on May 1, 2025. EU product information can be accessed via the Summary of Product Characteristics\u00a0found <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/emcitate-epar-product-information_en.pdf\" rel=\"noopener\" target=\"_blank\">here<\/a>.<\/p>\n<p>On March 27, 2026, Egetis announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date, or FDA decision date, of September 28, 2026. Emcitate\u00ae (tiratricol) is not approved in the USA.<\/p>\n<p>The NDA for Emcitate\u00ae (tiratricol) for treatment of MCT8 deficiency is based on clinical data from Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study and the US Expanded Access Program.<\/p>\n<p>Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.<\/p>\n<p>The drug candidate Aladote\u00ae (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb\/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote\u00ae has been parked. Aladote\u00ae has been granted ODD in the US and in the EU.<\/p>\n<p>Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).<br \/>For more information, see <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Forward-looking statements<\/strong><\/p>\n<hr\/>\n<p>This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the commercialization and availability of Emcitate\u00ae (tiratricol) in the United States, the timing and outcome of potential monetization of the Rare Pediatric Disease Priority Review Voucher, the expected capabilities of the Company\u2019s patient access and distribution infrastructure, the anticipated benefits of Emcitate for patients with MCT8 deficiency, and the Company\u2019s broader strategic plans for the development and commercialization of therapies for rare diseases. Forward-looking statements can generally be identified by words such as \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cpotential,\u201d or similar expressions, although not all forward-looking statements contain these words.<br \/>These statements are based on the Company\u2019s current expectations, assumptions, and assessments as of the date of this press release and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to: risks related to the commercial launch and market acceptance of Emcitate in the United States; the ability to establish and maintain adequate commercial infrastructure, including distribution, patient support, and reimbursement arrangements; the timing and terms of any monetization of the Priority Review Voucher, which is subject to market conditions and the availability of interested purchasers; potential post-marketing requirements or restrictions imposed by the FDA; the ability to maintain regulatory approvals in the United States and the European Union; competition from existing or future therapies; the Company\u2019s ability to secure adequate funding for its operations and commercial activities; and general economic, market, and business conditions.<br \/>For a further description of risks and uncertainties that could affect the Company\u2019s business and results, reference is made to the Company\u2019s most recent annual report and other filings with relevant regulatory authorities available at <a href=\"http:\/\/www.egetis.com\/\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or regulation.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Attachments<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/f83a321f-b9e5-4f35-8bad-417e8d292fb4\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan.pdf\" rel=\"noopener\" target=\"_blank\">Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, Sweden, August 31, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency in Japan, has been granted Orphan Drug Designation (ODD) for tiratricol for MCT8 [&hellip;]","protected":false},"template":"","class_list":["post-5597","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, Sweden, August 31, 2026. Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency in Japan, has been granted Orphan Drug Designation (ODD) for tiratricol for MCT8 [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:45+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\\\/\",\"name\":\"Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan - 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Egetis Therapeutics AB (publ) (\u201cEgetis\u201d or the \u201cCompany\u201d) (NASDAQ Stockholm: EGTX), today announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate\u00ae (tiratricol) for the treatment of MCT8 deficiency in Japan, has been granted Orphan Drug Designation (ODD) for tiratricol for MCT8 [&hellip;]","og_url":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/","og_site_name":"Egetis Therapeutics","article_modified_time":"2026-09-29T07:54:45+00:00","og_image":[{"width":1200,"height":630,"url":"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_site":"@Egetis_EGTX","twitter_misc":{"Ber\u00e4knad l\u00e4stid":"4 minuter"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/","url":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/","name":"Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan - Egetis Therapeutics","isPartOf":{"@id":"https:\/\/www.egetis.com\/sv\/#website"},"datePublished":"2026-08-31T06:00:00+00:00","dateModified":"2026-09-29T07:54:45+00:00","breadcrumb":{"@id":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/#breadcrumb"},"inLanguage":"sv-SE","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-granted-orphan-drug-designation-for-mct8-deficiency-in-japan\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Hem","item":"https:\/\/www.egetis.com\/sv\/"},{"@type":"ListItem","position":2,"name":"MFN-nyheter","item":"https:\/\/www.egetis.com\/sv\/news\/"},{"@type":"ListItem","position":3,"name":"Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan"}]},{"@type":"WebSite","@id":"https:\/\/www.egetis.com\/sv\/#website","url":"https:\/\/www.egetis.com\/sv\/","name":"Egetis Therapeutics","description":"Vi \"tar hand om de s\u00e4llsynta","publisher":{"@id":"https:\/\/www.egetis.com\/sv\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.egetis.com\/sv\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"sv-SE"},{"@type":"Organization","@id":"https:\/\/www.egetis.com\/sv\/#organization","name":"Egetis Therapeutics","url":"https:\/\/www.egetis.com\/sv\/","logo":{"@type":"ImageObject","inLanguage":"sv-SE","@id":"https:\/\/www.egetis.com\/sv\/#\/schema\/logo\/image\/","url":"http:\/\/www.egetis.com\/wp-content\/uploads\/2023\/04\/egetis-logo.svg","contentUrl":"http:\/\/www.egetis.com\/wp-content\/uploads\/2023\/04\/egetis-logo.svg","width":246,"height":54,"caption":"Egetis Therapeutics"},"image":{"@id":"https:\/\/www.egetis.com\/sv\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/x.com\/Egetis_EGTX","https:\/\/www.linkedin.com\/company\/egetis-therapeutics-ab","https:\/\/youtube.com\/@MCT8Deficiency"]}]}},"_links":{"self":[{"href":"https:\/\/www.egetis.com\/sv\/wp-json\/wp\/v2\/mfn_news\/5597","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.egetis.com\/sv\/wp-json\/wp\/v2\/mfn_news"}],"about":[{"href":"https:\/\/www.egetis.com\/sv\/wp-json\/wp\/v2\/types\/mfn_news"}],"wp:attachment":[{"href":"https:\/\/www.egetis.com\/sv\/wp-json\/wp\/v2\/media?parent=5597"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}},{"id":5598,"date":"2026-08-31T06:00:00","date_gmt":"2026-08-31T06:00:00","guid":{"rendered":"http:\/\/localhost:10018\/news\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\/"},"modified":"2026-09-29T07:54:45","modified_gmt":"2026-09-29T07:54:45","slug":"tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan","status":"publish","type":"mfn_news","link":"https:\/\/www.egetis.com\/sv\/news\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\/","title":{"rendered":"Tiratricol beviljas s\u00e4rl\u00e4kemedelsstatus f\u00f6r MCT8-brist i Japan"},"content":{"rendered":"<div class=\"mfn-body\">\n<p><strong>Stockholm, 31 augusti, 2026.<\/strong> Egetis Therapeutics AB (publ) (&#34;Egetis&#34; eller &#34;Bolaget&#34;) (NASDAQ Stockholm: EGTX) meddelade idag att dess partner Fujimoto Pharmaceutical Corporation, som innehar en exklusiv licens f\u00f6r att utveckla och kommersialisera Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist i Japan, har beviljats s\u00e4rl\u00e4kemedelsstatus (Orphan Drug Designation, ODD) f\u00f6r tiratricol vid MCT8-brist av Japans h\u00e4lso-, arbetsmarknads- och v\u00e4lf\u00e4rdsministerium (Ministry of Health, Labour and Welfare).<\/p>\n<p>En av f\u00f6rdelarna med s\u00e4rl\u00e4kemedelsstatus i Japan \u00e4r att en ans\u00f6kan om marknadsgodk\u00e4nnande blir ber\u00e4ttigad till prioriterad granskning, vilket kan f\u00f6rkorta granskningstiden fr\u00e5n cirka tolv till nio m\u00e5nader. S\u00e4rl\u00e4kemedelsstatus medf\u00f6r \u00e4ven en f\u00f6rl\u00e4ngning av marknadsexklusiviteten till tio \u00e5r.<\/p>\n<p>Emcitate (tiratricol) har ocks\u00e5 erh\u00e5llit s\u00e4rl\u00e4kemedelsstatus f\u00f6r behandling av MCT8-brist i USA och EU.<br \/>\u00a0<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-9916b4d0a4f8\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta:<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, vd<br \/>+46 (0) 733 542 062<br \/>nicklas.westerholm@egetis.com<br \/>\u00a0<br \/>Karl H\u00e5rd, Head of Investor Relations, Communications &amp; Business Development<br \/>+46 (0) 733 011 944<br \/>karl.hard@egetis.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">Om Egetis Therapeutics AB<\/strong><\/p>\n<hr\/>\n<p>Egetis \u00e4r ett innovativt och integrerat l\u00e4kemedelsbolag, fokuserat p\u00e5 projekt i sen klinisk utvecklingsfas och kommersialisering inom s\u00e4rl\u00e4kemedelsomr\u00e5det f\u00f6r behandling av allvarliga och s\u00e4llsynta sjukdomar med betydande medicinska behov.<\/p>\n<p>Bolagets ledande l\u00e4kemedelskandidat Emcitate\u00ae (tiratrikol) har utvecklats som den f\u00f6rsta och enda godk\u00e4nda behandlingen f\u00f6r patienter med MCT8-brist, en s\u00e4llsynt sjukdom med ett stort medicinskt behov. Egetis erh\u00f6ll marknadsgodk\u00e4nnande f\u00f6r Emcitate\u00ae \u00a0i EU i februari 2025 som den f\u00f6rsta och enda behandlingen f\u00f6r MCT8-brist. Egetis inledde lanseringen av Emcitate\u00ae \u00a0i Tyskland den 1 maj 2025. EU produktinformation kan f\u00e5s via produktresum\u00e9n <a href=\"https:\/\/www.ema.europa.eu\/sv\/documents\/product-information\/emcitate-epar-product-information_sv.pdf\" rel=\"noopener\" target=\"_blank\">h\u00e4r<\/a>.<\/p>\n<p>Den 27 mars 2026 meddelade Egetis att FDA har accepterat Bolagets NDA f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8\u2011brist. Ans\u00f6kan har beviljats prioriterad granskning (Priority Review) och tilldelats ett m\u00e5ldatum enligt Prescription Drug User Fee Act (PDUFA), vilket utg\u00f6r FDA:s beslutsdatum, den 28 september 2026. Emcitate\u00ae (tiratricol) \u00e4r inte godk\u00e4nd i USA.<\/p>\n<p>NDA:n f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist baseras p\u00e5 kliniska data fr\u00e5n Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study och det amerikanska Expanded Access-programmet.<\/p>\n<p>Tiratrikol har s\u00e4rl\u00e4kemedelsstatus (\u2019orphan drug designation\u2019, ODD) i USA och EU f\u00f6r MCT8-brist och RTH-beta. MCT8-brist och RTH-beta \u00e4r separata indikationer med distinkta patientpopulationer. I USA har Emcitate \u00e4ven beviljats Breakthrough Therapy Designation och Rare Pediatric Disease Designation (RPDD), vilket ger Egetis m\u00f6jligheten att erh\u00e5lla en Priority Review Voucher (PRV), efter marknadsgodk\u00e4nnande. I UK har Emcitate erh\u00e5llit Promising Innovative Medicine status av den brittiska l\u00e4kemedelsmyndigheten MHRA.<\/p>\n<p>Aladote\u00ae (calmangafodipir) \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att reducera risken f\u00f6r akuta leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. En \u201dproof of principle\u201d-studie har framg\u00e5ngsrikt avslutats och utformningen av en registreringsgrundande fas 2\/3 studie, Albatross, med syfte att ans\u00f6ka om marknadsgodk\u00e4nnande i USA och Europa har slutf\u00f6rts efter diskussioner med l\u00e4kemedelsmyndigheterna i USA, EU och Storbritannien. Utvecklingsprogrammet f\u00f6r Aladote\u00ae \u00a0har parkerats. Aladote\u00ae \u00a0har beviljats ODD i USA och EU.<\/p>\n<p>Egetis Therapeutics \u00e4r noterad p\u00e5 Nasdaq Stockholms huvudlista (Nasdaq Stockholm: EGTX) .<br \/>F\u00f6r mer information, se <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-572cac35a41d\">\n<p><strong class=\"mfn-heading-1\">Fram\u00e5tblickande uttalanden<\/strong><\/p>\n<hr\/>\n<p>Detta pressmeddelande inneh\u00e5ller fram\u00e5tblickande uttalanden i den mening som avses i till\u00e4mplig v\u00e4rdepapperslagstiftning, inklusive uttalanden avseende kommersialiseringen och tillg\u00e4ngligheten av Emcitate\u00ae (tiratricol) i USA, tidpunkten f\u00f6r och utfallet av en eventuell monetisering av Priority Review Voucher f\u00f6r s\u00e4llsynta pediatriska sjukdomar (Rare Pediatric Disease Priority Review Voucher), den f\u00f6rv\u00e4ntade kapaciteten i Bolagets infrastruktur f\u00f6r patient\u00e5tkomst och distribution, de f\u00f6rv\u00e4ntade f\u00f6rdelarna med Emcitate f\u00f6r patienter med MCT8-brist samt Bolagets \u00f6vergripande strategiska planer f\u00f6r utveckling och kommersialisering av behandlingar f\u00f6r s\u00e4llsynta sjukdomar. Fram\u00e5tblickande uttalanden kan i allm\u00e4nhet identifieras genom ord s\u00e5som \u201df\u00f6rv\u00e4ntar\u201d, \u201dbed\u00f6mer\u201d, \u201davser\u201d, \u201danser\u201d, \u201duppskattar\u201d, \u201dplanerar\u201d, \u201dkommer att\u201d, \u201dkan\u201d, \u201dskulle kunna\u201d, \u201dpotentiell\u201d eller liknande uttryck, \u00e4ven om inte alla fram\u00e5tblickande uttalanden inneh\u00e5ller s\u00e5dana ord.<br \/>Dessa uttalanden baseras p\u00e5 Bolagets nuvarande f\u00f6rv\u00e4ntningar, antaganden och bed\u00f6mningar per dagen f\u00f6r detta pressmeddelande och \u00e4r f\u00f6rem\u00e5l f\u00f6r risker, os\u00e4kerhetsfaktorer och andra omst\u00e4ndigheter som kan medf\u00f6ra att faktiska resultat avviker v\u00e4sentligt fr\u00e5n dem som uttryckligen eller underf\u00f6rst\u00e5tt anges i uttalandena. S\u00e5dana faktorer omfattar, men \u00e4r inte begr\u00e4nsade till, risker relaterade till den kommersiella lanseringen av och marknadsacceptansen f\u00f6r Emcitate i USA, Bolagets f\u00f6rm\u00e5ga att etablera och uppr\u00e4tth\u00e5lla en \u00e4ndam\u00e5lsenlig kommersiell infrastruktur, inklusive distributions-, patientst\u00f6ds- och ers\u00e4ttningsl\u00f6sningar, tidpunkten f\u00f6r och villkoren f\u00f6r en eventuell monetisering av Priority Review Voucher, vilken \u00e4r beroende av marknadsf\u00f6rh\u00e5llanden och tillg\u00e5ngen p\u00e5 intresserade k\u00f6pare, eventuella krav eller begr\u00e4nsningar efter marknadsgodk\u00e4nnande som kan komma att inf\u00f6ras av den amerikanska l\u00e4kemedelsmyndigheten FDA, Bolagets f\u00f6rm\u00e5ga att uppr\u00e4tth\u00e5lla regulatoriska godk\u00e4nnanden i USA och Europeiska unionen, konkurrens fr\u00e5n befintliga eller framtida behandlingar, Bolagets m\u00f6jlighet att s\u00e4kerst\u00e4lla tillr\u00e4cklig finansiering f\u00f6r sin verksamhet och sina kommersiella aktiviteter samt allm\u00e4nna ekonomiska, marknadsm\u00e4ssiga och aff\u00e4rsm\u00e4ssiga f\u00f6rh\u00e5llanden.<br \/>F\u00f6r en n\u00e4rmare beskrivning av risker och os\u00e4kerhetsfaktorer som kan p\u00e5verka Bolagets verksamhet och resultat h\u00e4nvisas till Bolagets senaste \u00e5rsredovisning samt \u00f6vriga handlingar som getts in till relevanta tillsynsmyndigheter och som finns tillg\u00e4ngliga p\u00e5 www.egetis.com.<br \/>Bolaget \u00e5tar sig inte n\u00e5gon skyldighet att offentligt uppdatera eller revidera fram\u00e5tblickande uttalanden, vare sig till f\u00f6ljd av ny information, framtida h\u00e4ndelser eller av andra sk\u00e4l, annat \u00e4n vad som f\u00f6ljer av till\u00e4mplig lag eller regelverk.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/66db67b5-f228-499e-84ab-02d3a12db9f5\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan.pdf\" rel=\"noopener\" target=\"_blank\">Tiratricol beviljas s\u00e4rl\u00e4kemedelsstatus f\u00f6r MCT8-brist i Japan<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"Stockholm, 31 augusti, 2026. Egetis Therapeutics AB (publ) (&#34;Egetis&#34; eller &#34;Bolaget&#34;) (NASDAQ Stockholm: EGTX) meddelade idag att dess partner Fujimoto Pharmaceutical Corporation, som innehar en exklusiv licens f\u00f6r att utveckla och kommersialisera Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist i Japan, har beviljats s\u00e4rl\u00e4kemedelsstatus (Orphan Drug Designation, ODD) f\u00f6r tiratricol vid MCT8-brist av Japans h\u00e4lso-, arbetsmarknads- [&hellip;]","protected":false},"template":"","class_list":["post-5598","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn-lang-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tiratricol beviljas s\u00e4rl\u00e4kemedelsstatus f\u00f6r MCT8-brist i Japan - Egetis Therapeutics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.egetis.com\/sv\/news\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Tiratricol beviljas s\u00e4rl\u00e4kemedelsstatus f\u00f6r MCT8-brist i Japan - Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 31 augusti, 2026. Egetis Therapeutics AB (publ) (&#034;Egetis&#034; eller &#034;Bolaget&#034;) (NASDAQ Stockholm: EGTX) meddelade idag att dess partner Fujimoto Pharmaceutical Corporation, som innehar en exklusiv licens f\u00f6r att utveckla och kommersialisera Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist i Japan, har beviljats s\u00e4rl\u00e4kemedelsstatus (Orphan Drug Designation, ODD) f\u00f6r tiratricol vid MCT8-brist av Japans h\u00e4lso-, arbetsmarknads- [&hellip;]\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/news\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T07:54:45+00:00\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/2026\/08\/egetis-share-image.png\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:site\" content=\"@Egetis_EGTX\" class=\"yoast-seo-meta-tag\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" class=\"yoast-seo-meta-tag\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minuter\" class=\"yoast-seo-meta-tag\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\\\/\",\"url\":\"https:\\\/\\\/www.egetis.com\\\/sv\\\/news\\\/tiratricol-beviljas-sarlakemedelsstatus-for-mct8-brist-i-japan\\\/\",\"name\":\"Tiratricol beviljas s\u00e4rl\u00e4kemedelsstatus f\u00f6r MCT8-brist i Japan - 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Kvartalsrapport Q2 2026"},"content":{"rendered":"<div class=\"mfn-body\">\n<p><strong>FDA:s granskning av NDA:n f\u00f6r Emcitate\u00ae fortskrider enligt plan inf\u00f6r PDUFA-datumet den 28 september 2026<\/strong><\/p>\n<ul>\n<li><strong>Egetis beviljades patent i USA f\u00f6r sammans\u00e4ttning av tiratrikol f\u00f6r MCT8-brist<\/strong><\/li>\n<li><strong>F\u00f6rs\u00e4ljningen av Emcitate i Europa uppgick till MSEK 17,4 under Q2 2026, en \u00f6kning med 23% vid fasta valutakurser (CER) j\u00e4mf\u00f6rt med Q2 2025<\/strong><\/li>\n<li><strong>Egetis genomf\u00f6rde framg\u00e5ngsrikt en \u00f6vertecknad riktad nyemission om MSEK 350, motsvarande cirka MUSD 38 f\u00f6re emissionskostnader<\/strong><\/li>\n<\/ul>\n<p><strong>Finansiell \u00f6versikt april-juni<\/strong><br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Kvartalets int\u00e4kter uppgick till MSEK 17,4 (14,5), +23% vid fasta valutakurser (CER)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Kvartalets resultat uppgick till MSEK -108,9 (-77,6)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Likvida medel vid kvartalets utg\u00e5ng uppgick till MSEK 378,4 (202,6)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Kassafl\u00f6det f\u00f6r kvartalet uppgick till MSEK 230,2 (-69,2)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Resultat per aktie f\u00f6re och efter utsp\u00e4dning uppgick till SEK -0,2 (-0,2)<\/p>\n<p><strong>Finansiell \u00f6versikt januari-juni<\/strong><br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Int\u00e4kterna f\u00f6r perioden uppgick till MSEK 30,7 (27,1), +13% vid fasta valutakurser (CER)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Periodens nettoresultat uppgick till MSEK -203,4 (-140,5)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Likvida medel uppgick till MSEK 378,4 (202,6) vid periodens utg\u00e5ng<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Kassafl\u00f6det f\u00f6r perioden uppgick till MSEK 157,5 (-143,4)<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Resultat per aktie f\u00f6re och efter utsp\u00e4dning uppgick till SEK -0,5 (-0,4)<\/p>\n<p><strong>V\u00e4sentliga h\u00e4ndelser under kvartalet<\/strong><br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 FDA:s granskning av Emcitates NDA fortskrider enligt plan mot PDUFA-datumet den 28 september 2026<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Egetis genomf\u00f6rde framg\u00e5ngsrikt en \u00f6vertecknad riktad nyemission om MSEK 350, motsvarande cirka MUSD 38 f\u00f6re emissionskostnader<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Egetis beviljades patent i USA f\u00f6r sammans\u00e4ttning av tiratrikol f\u00f6r MCT8-brist<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Egetis erh\u00f6ll villkorat godk\u00e4nnande fr\u00e5n FDA f\u00f6r produktnamnet Emcitate\u00ae<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tiago Nunes uts\u00e5gs till Chief Medical Officer<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Birgitte Volck och Jay Donovan Wu valdes till nya styrelseledam\u00f6ter vid \u00e5rsst\u00e4mman<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Prisf\u00f6rhandlingarna f\u00f6r Emcitate inom ramen f\u00f6r den tyska ers\u00e4ttningsprocessen (AMNOG) slutf\u00f6rdes under Q2 2026 och g\u00e4ller fr\u00e5n den 1 augusti<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Egetis meddelade att Behind the Mystery-avsnittet om MCT8-brist s\u00e4nds i repris p\u00e5 Lifetime-kanalen i USA<br \/>\u00a0<br \/><strong>V\u00e4sentliga h\u00e4ndelser efter kvartalet<\/strong><br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Egetis ingick samarbets- och leveransavtal med Orspec Pharma f\u00f6r Australien och Nya Zeeland<\/p>\n<p><strong class=\"mfn-heading-1\">VD har ordet<\/strong><br \/><strong><br \/><\/strong><strong>Framsteg i FDA:s granskning av Emcitate\u00ae NDA i USA<\/strong><br \/>Den viktigaste h\u00e4ndelsen under f\u00f6rsta halv\u00e5ret 2026 var att v\u00e5r registreringsans\u00f6kan (NDA) f\u00f6r Emcitate\u00ae (tiratrikol) f\u00f6r behandling av MCT8-brist accepterades f\u00f6r granskning av den amerikanska l\u00e4kemedels-myndigheten FDA och dessutom beviljades prioriterad granskning. Ans\u00f6kan tilldelades ett m\u00e5ldatum enligt Prescription Drug User Fee Act (PDUFA), vilket inneb\u00e4r att FDA:s beslut f\u00f6rv\u00e4ntas den 28 september 2026. Granskningsprocessen har hittills varit konstruktiv. B\u00e5de det s\u00e5 kallade mid-cycle-m\u00f6tet och late-cycle-m\u00f6tet har genomf\u00f6rts med FDA, som bekr\u00e4ftat att myndigheten f\u00f6rv\u00e4ntar sig att slutf\u00f6ra sin granskning enligt plan till PDUFA-datumet den 28 september 2026. FDA har ocks\u00e5 meddelat att man inte avser att sammankalla n\u00e5gon extern r\u00e5dgivande expertkommitt\u00e9 (Advisory Committee) som en del av processen.<br \/>\u00a0<br \/><strong>F\u00f6rberedelser inf\u00f6r lanseringen i USA<\/strong><br \/>Vi har intensifierat v\u00e5ra f\u00f6rberedelser inf\u00f6r en kommersiell lansering i USA och fortsatt bygga upp v\u00e5r kommersiella organisation samt v\u00e5r verksamhet inom Medical Affairs. Under perioden har vi \u00e4ven ing\u00e5tt avtal med ett specialistapotek (specialty pharmacy) och en distribut\u00f6r f\u00f6r att s\u00e4kerst\u00e4lla att patienter med MCT8-brist f\u00e5r tillg\u00e5ng till Emcitate efter ett eventuellt godk\u00e4nnande. Som tidigare kommunicerats har vi vidareutvecklat v\u00e5ra informationswebbplatser f\u00f6r v\u00e5rdpersonal respektive anh\u00f6riga, <a href=\"http:\/\/www.mct8deficiency.com\/\" rel=\"noopener\" target=\"_blank\">www.mct8deficiency.com<\/a> respektive <a href=\"http:\/\/www.lifewithmct8deficiency.com\/\" rel=\"noopener\" target=\"_blank\">www.lifewithmct<\/a> <a href=\"http:\/\/www.lifewithmct8deficiency.com\/\" rel=\"noopener\" target=\"_blank\">8deficiency.com,<\/a> med syftet att erbjuda tydlig, omfattande och l\u00e4ttillg\u00e4nglig information om sjukdomen anpassad till respektive m\u00e5lgrupp.<br \/>Vi har ocks\u00e5 meddelat att avsnittet om MCT8-brist i TV-serien <em>Behind the Mystery<\/em>, som tidigare s\u00e4nts inom programmet <em>The Balancing Act\u00ae <\/em>p\u00e5 den amerikanska tv-kanalen Lifetime Network, kommer att s\u00e4ndas nationellt p\u00e5 nytt. Programmet uppm\u00e4rksammar MCT8-brist (Allan-Herndon-Dudleys syndrom), en<br \/>s\u00e4llsynt, allvarlig och livsf\u00f6rkortande genetisk sjukdom som orsakas av mutationer i genen som kodar f\u00f6r MCT8. Programmet kan ses h\u00e4r: <a href=\"http:\/\/www.lifewithmct8deficiency.com\/\" rel=\"noopener\" target=\"_blank\">www.lifewithmct8deficiency.com<\/a><br \/>\u00a0<br \/><strong>Expanded Access Program i USA<\/strong><br \/>P\u00e5 beg\u00e4ran av FDA har Egetis etablerat ett Expanded Access Program (EAP) i USA. Programmet omfattar f\u00f6r n\u00e4rvarande 17 sjukhus och cirka 60 patienter behandlas idag med tiratrikol inom ramen f\u00f6r programmet. EAP ger l\u00e4kare m\u00f6jlighet att erbjuda tiratrikol till patienter som inte \u00e4r ber\u00e4ttigade att delta i kliniska studier innan ett marknadsgodk\u00e4nnande erh\u00e5llits. Programmet m\u00f6jligg\u00f6r \u00e4ven fortsatt behandling f\u00f6r patienter som tidigare deltagit i studierna ReTRIACt och Triac Trial II. F\u00f6r mer information om EAP-programmet, v\u00e4nligen<br \/>se: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05911399\" rel=\"noopener\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT05911399<\/a><br \/>\u00a0<br \/><strong>Priority Review Vouchers forts\u00e4tter att betinga h\u00f6ga v\u00e4rden<\/strong><br \/>Emcitate har Rare Pediatric Disease Designation status fr\u00e5n FDA, vilket inneb\u00e4r att Egetis vid ett eventuellt godk\u00e4nnande \u00e4r ber\u00e4ttigat till en Priority Review Voucher (PRV). En s\u00e5dan voucher kan anv\u00e4ndas f\u00f6r att erh\u00e5lla prioriterad granskning av en framtida registreringsans\u00f6kan, vilket f\u00f6rkortar FDA:s normala granskningstid fr\u00e5n tio m\u00e5nader till cirka sex m\u00e5nader. Eftersom dessa vouchers \u00e4r \u00f6verl\u00e5tbara finns en aktiv andrahandsmarknad. Under 2026 har PRV:er s\u00e5lts f\u00f6r mellan MUSD 180 och 220. Det h\u00f6gsta offentliggjorda priset om MUSD 220 meddelades av Bristol Myers Squibb den 30 juli 2026. Egetis har r\u00e4tt till 50 procent av nettoint\u00e4kterna fr\u00e5n en eventuell f\u00f6rs\u00e4ljning av en Emcitate-relaterad PRV. Resterande del utg\u00e5r som till\u00e4ggsk\u00f6peskilling till s\u00e4ljarna av Rare Thyroid Therapeutics International AB i samband med f\u00f6rv\u00e4rvet av Emcitate 2020.<\/p>\n<p><strong>Patent beviljat f\u00f6r tiratrikol sammans\u00e4ttning f\u00f6r MCT8-brist<\/strong><br \/>Den 5 maj 2026 beviljade det amerikanska patentverket USPTO patent nummer US 12611383B1 f\u00f6r bolagets patentans\u00f6kan Nr. 19\/261,360 avseende en ny tiratrikol sammans\u00e4ttning f\u00f6r behandling av MCT8-brist. Detta \u00e4r det f\u00f6rsta beviljade patentet f\u00f6r Emcitate och ger skydd f\u00f6r en ny sammans\u00e4ttning inneh\u00e5llande tiratrikol som aktiv substans, utvecklad f\u00f6r att korrigera den rubbade sk\u00f6ldk\u00f6rtel-hormonsignalering som k\u00e4nnetecknar MCT8-brist. Patentet omfattar bland annat behandling av MCT8-brist med den patenterade farmaceutiska sammans\u00e4ttningen, doseringsregimer samt sammans\u00e4ttningar av tiratrikol med specifika hj\u00e4lp\u00e4mnen. Patentet utg\u00f6r en viktig milstolpe i arbetet med att st\u00e4rka bolagets immateriella r\u00e4ttigheter. Egetis bed\u00f6mer att patentet kommer att kunna listas i FDA:s Orange Book och har ett utg\u00e5ngsdatum \u00e5r 2045.<br \/>\u00a0<br \/><strong>Kommersialisering av Emcitate i Europa<\/strong> <br \/>Oms\u00e4ttningen fr\u00e5n f\u00f6rs\u00e4ljningen av Emcitate i Europa uppgick under det andra kvartalet 2026 till MSEK 17,4<br \/>vilket motsvarar en \u00f6kning om 23 procent vid konstanta valutakurser j\u00e4mf\u00f6rt med f\u00f6reg\u00e5ende \u00e5r. Lanseringen inleddes i Tyskland i maj 2025. I oktober samma \u00e5r p\u00e5b\u00f6rjade vi prisf\u00f6rhandlingar med den tyska sjukf\u00f6rs\u00e4kringsorganisationen GKV-Spitzenverband. F\u00f6rhandlingarna avslutades framg\u00e5ngsrikt under det andra kvartalet 2026, och vi \u00e4r glada \u00f6ver att de tyska myndigheterna har erk\u00e4nt v\u00e4rdet av v\u00e5rt s\u00e4rl\u00e4kemedel.<br \/>\u00a0<br \/>V\u00e5r kommersiella huvudstrategi \u00e4r fortsatt att utveckla marknaden genom m\u00f6ten med behandlande l\u00e4kare, n\u00e4rvaro vid vetenskapliga kongresser, utbildningsinitiativ och aktiviteter f\u00f6r att \u00f6ka kunskapen om sjukdomen. Fokus ligger fortsatt fr\u00e4mst p\u00e5 barnendokrinologer och barnneurologer.<br \/>\u00a0<br \/>I Spanien har vi nyligen l\u00e4mnat in en nationell ans\u00f6kan om pris och subvention f\u00f6r Emcitate. I Italien och Frankrike planerar vi att ytterligare st\u00e4rka v\u00e5ra v\u00e4rdeunderlag med \u00f6verlevnadsdata f\u00f6r Emcitate n\u00e4r dessa publicerats i en vetenskapligt granskad tidskrift av Erasmus Medical Center.<\/p>\n<p><strong>V\u00e5ra partners forts\u00e4tter att g\u00f6ra framsteg<\/strong><br \/>V\u00e5r japanska partner Fujimoto Pharmaceuticals, som innehar den exklusiva licensen f\u00f6r utveckling och kommersialisering av Emcitate f\u00f6r MCT8-brist i Japan, forts\u00e4tter f\u00f6rberedelserna inf\u00f6r en japansk registreringsans\u00f6kan baserad p\u00e5 data fr\u00e5n det globala kliniska utvecklingsprogrammet. Ans\u00f6kan v\u00e4ntas l\u00e4mnas in i b\u00f6rjan av 2027.<br \/>\u00a0<br \/>V\u00e5ra distributionspartners Er-Kim (Turkiet samt Central-, \u00d6st- och Syd\u00f6steuropa) och Taiba Rare (Gulfregionen) arbetar aktivt med att identifiera patienter inom sina respektive marknader och har initierat finansierad behandling f\u00f6r ytterligare patienter. I Australien har vi nyligen tecknat ett leveransavtal med Orspec Pharma f\u00f6r att kunna n\u00e5 fler patienter med MCT8-brist i Australien och Nya Zeeland.<br \/>\u00a0<br \/><strong>N\u00e4sta steg: Emcitate vid RTH-beta<\/strong><br \/>Arbetet med att f\u00e4rdigst\u00e4lla utvecklingsplanen f\u00f6r Emcitate vid Resistance to Thyroid Hormone (RTH)-beta fortskrider. Vi sammankallar f\u00f6r n\u00e4rvarande en vetenskaplig r\u00e5dgivande expertgrupp och f\u00f6rbereder regulatoriska kontakter f\u00f6r att diskutera den f\u00f6reslagna kliniska utvecklingsplanen.<br \/>\u00a0<br \/><strong>Kassaposition<\/strong><br \/>Per den 30 juni 2026 uppgick koncernens likvida medel till cirka MSEK 378 (203). Den 21 april 2026 genomf\u00f6rde vi framg\u00e5ngsrikt en \u00f6vertecknad riktad nyemission om MSEK 350 (cirka MUSD 38) f\u00f6re emissionskostnader till en teckningskurs om 5,25 kronor per aktie, motsvarande st\u00e4ngningskursen p\u00e5 Nasdaq Stockholm samma dag. Vi \u00e4r s\u00e4rskilt glada \u00f6ver det starka deltagandet fr\u00e5n b\u00e5de befintliga aktie\u00e4gare och flera nya internationella specialistinvesterare inom sektorn, vilket ytterligare breddat v\u00e5r aktie\u00e4garbas.<br \/>\u00a0<br \/>Efter ett eventuellt godk\u00e4nnande av Emcitate i USA den 28 september 2026 avser vi att realisera v\u00e4rdet av den tillh\u00f6rande PRV:n, i f\u00f6rsta hand f\u00f6r att st\u00f6dja v\u00e5ra lanseringsaktiviteter p\u00e5 den amerikanska marknaden.<br \/>\u00a0<br \/><strong>Utsikter<\/strong><br \/>2026 \u00e4r ett \u00e5r pr\u00e4glat av flera viktiga milstolpar f\u00f6r Egetis. V\u00e5rt team fokuserar p\u00e5 fyra prioriterade omr\u00e5den:<br \/>\u00a0<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Framg\u00e5ngsrikt samarbete med FDA under granskningen av Emcitate NDA:n f\u00f6r att erh\u00e5lla marknadsgodk\u00e4nnande senast p\u00e5 PDUFA-datumet den 28 september 2026<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 F\u00f6rberedelser inf\u00f6r lanseringen av Emcitate i USA<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Optimera pris- och ers\u00e4ttningsniv\u00e5er samt forts\u00e4tta lanseringen av Emcitate i Europa<br \/>\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Att f\u00e4rdigst\u00e4lla utvecklingsplanen f\u00f6r Emcitate inom RTH-beta<br \/>\u00a0<br \/>Stockholm, 21 augusti, 2026<br \/>\u00a0<br \/><strong>Nicklas Westerholm<\/strong> <br \/>VD<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-contacts mfn-7a7f51f1d6b7\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta<\/strong><\/p>\n<hr\/>\n<p>Nicklas Westerholm, VD<br \/>nicklas.westerholm@egetis.com<br \/>\u00a0+46\u00a0(0) 733 542 062<\/p>\n<p>Yilmaz Mahshid, CFO<br \/>yilmaz.mahshid@egetis.com<br \/>+46 (0) 722\u00a0316\u00a0800<\/p>\n<p>Karl H\u00e5rd, Head of Investor Relations &amp; Business Development<br \/>karl.hard@egetis.com<br \/>+46 (0) 733 011 944<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-regulatory mfn-regulatory-mar-vpml\">\n<p><em>Denna information \u00e4r s\u00e5dan information som Egetis Therapeutics \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning och lagen om v\u00e4rdepappersmarknaden. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersoners f\u00f6rsorg, f\u00f6r offentligg\u00f6rande den 2026-08-21 07:00 CEST.<\/em><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-15ae610fc15b\">\n<p><strong class=\"mfn-heading-1\">Om Egetis Therapeutics AB<\/strong><\/p>\n<hr\/>\n<p>Egetis \u00e4r ett innovativt och integrerat l\u00e4kemedelsbolag, fokuserat p\u00e5 projekt i sen klinisk utvecklingsfas och kommersialisering inom s\u00e4rl\u00e4kemedelsomr\u00e5det f\u00f6r behandling av allvarliga och s\u00e4llsynta sjukdomar med betydande medicinska behov.<\/p>\n<p>Bolagets ledande l\u00e4kemedelskandidat Emcitate\u00ae (tiratrikol) har utvecklats som den f\u00f6rsta och enda godk\u00e4nda behandlingen f\u00f6r patienter med MCT8-brist, en s\u00e4llsynt sjukdom med ett stort medicinskt behov. Egetis erh\u00f6ll marknadsgodk\u00e4nnande f\u00f6r Emcitate\u00ae \u00a0i EU i februari 2025 som den f\u00f6rsta och enda behandlingen f\u00f6r MCT8-brist. Egetis inledde lanseringen av Emcitate\u00ae \u00a0i Tyskland den 1 maj 2025. Emcitate\u00ae (tiratricol) \u00e4r inte godk\u00e4nd i USA.<\/p>\n<p>Den 27 mars 2026 meddelade Egetis att FDA har accepterat Bolagets NDA f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8\u2011brist. Ans\u00f6kan har beviljats prioriterad granskning (Priority Review) och tilldelats ett m\u00e5ldatum enligt Prescription Drug User Fee Act (PDUFA), vilket utg\u00f6r FDA:s beslutsdatum, den 28 september 2026.<\/p>\n<p>NDA:n f\u00f6r Emcitate\u00ae (tiratricol) f\u00f6r behandling av MCT8-brist baseras p\u00e5 kliniska data fr\u00e5n Triac Trial I, Triac Trial II, ReTRIACt, EMC Cohort Study, EMC Survival Study och det amerikanska Expanded Access-programmet.<\/p>\n<p>Tiratrikol har s\u00e4rl\u00e4kemedelsstatus (\u2019orphan drug designation\u2019, ODD) i USA och EU f\u00f6r MCT8-brist och RTH-beta. MCT8-brist och RTH-beta \u00e4r separata indikationer med distinkta patientpopulationer. I USA har Emcitate \u00e4ven beviljats Breakthrough Therapy Designation och Rare Pediatric Disease Designation (RPDD), vilket ger Egetis m\u00f6jligheten att erh\u00e5lla en Priority Review Voucher (PRV), efter marknadsgodk\u00e4nnande. I UK har Emcitate erh\u00e5llit Promising Innovative Medicine status av den brittiska l\u00e4kemedelsmyndigheten MHRA.<\/p>\n<p>Aladote\u00ae (calmangafodipir) \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att reducera risken f\u00f6r akuta leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. En \u201dproof of principle\u201d-studie har framg\u00e5ngsrikt avslutats och utformningen av en registreringsgrundande fas 2\/3 studie, Albatross, med syfte att ans\u00f6ka om marknadsgodk\u00e4nnande i USA och Europa har slutf\u00f6rts efter diskussioner med l\u00e4kemedelsmyndigheterna i USA, EU och Storbritannien. Utvecklingsprogrammet f\u00f6r Aladote\u00ae \u00a0har parkerats. Aladote\u00ae \u00a0har beviljats ODD i USA och EU.<\/p>\n<p>Egetis Therapeutics \u00e4r noterad p\u00e5 Nasdaq Stockholms huvudlista (Nasdaq Stockholm: EGTX) .<br \/>F\u00f6r mer information, se <a href=\"http:\/\/www.egetis.com\" rel=\"noopener\" target=\"_blank\">www.egetis.com<\/a>.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-primary\" href=\"https:\/\/storage.mfn.se\/886a0205-7283-4b52-8fd0-974f44d23309\/q2-2026-report-swe-20aug26c.pdf\" rel=\"noopener\" target=\"_blank\">Q2 2026 Report SWE 20Aug26c<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"FDA:s granskning av NDA:n f\u00f6r Emcitate\u00ae fortskrider enligt plan inf\u00f6r PDUFA-datumet den 28 september 2026 Egetis beviljades patent i USA f\u00f6r sammans\u00e4ttning av tiratrikol f\u00f6r MCT8-brist F\u00f6rs\u00e4ljningen av Emcitate i Europa uppgick till MSEK 17,4 under Q2 2026, en \u00f6kning med 23% vid fasta valutakurser (CER) j\u00e4mf\u00f6rt med Q2 2025 Egetis genomf\u00f6rde framg\u00e5ngsrikt en \u00f6vertecknad [&hellip;]","protected":false},"template":"","class_list":["post-5581","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-report-interim","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn-arc-event","mfn-news-tag-mfn-arc-event-report","mfn-news-tag-mfn","mfn-news-tag-mfn-report-interim-q2","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-report","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-regulatory-vpml"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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