Stockholm, Sweden, March 9, 2026. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX) today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company’s patent application No. 19/261,360 entitled “Pharmaceutical Compositions for Treating MCT8 Deficiency”. Now that Egetis have paid the issue fee, this Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
The allowed patent provides protection for a novel composition, which contains tiratricol as the active ingredient, designed to correct the disrupted thyroid hormone signaling characteristic of MCT8 deficiency. The allowed claims cover, among other things, a method of treating MCT8 deficiency with a pharmaceutical composition that encompasses tiratricol, including dosing regiments, and tiratricol compositions with specific excipients. This Notice of Allowance represents a significant milestone in strengthening the Company’s intellectual property portfolio supporting its lead investigational therapy. Egetis expects the resulting patent will be Orange Book-listable, with an anticipated expiration date of 2045.
Nicklas Westerholm, CEO, said: “We are very pleased to receive this Notice of Allowance, which reinforces the innovative nature of our therapeutic approach for patients with MCT8 deficiency. This accomplishment supports our commitment to advancing a much‑needed treatment option for this devastating disorder.”
Egetis also intends to seek corresponding patent protection in additional territories around the World, including Europe and Japan, based on a PCT International Patent Application that the Company has filed.
Egetis has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Emcitate® (tiratricol) for the treatment of MCT8 deficiency on January 29, 2026. The FDA is expected to confirm within 60 days that the NDA submission is complete. As a designated Fast Track and Breakthrough Therapy, Egetis has requested Priority Review, and if granted, the FDA review should be completed within six months following the 60-day filing review period. Thus, Egetis anticipates regulatory decision on the NDA application in September 2026.
