Stockholm, Sweden, February 4, 2026. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), today noted that the U.S. Food and Drug Administration’s (FDA’s) Rare Pediatric Disease Priority Review program has been prolonged from its previous sunset deadline on September 30, 2026 until September 30, 2029. This prolongation was part of the Mikaela Naylon Give Kids a Chance Act, which was adopted by Congress as part of the Congressional Bill H.R. 7148 and signed into law on February 3, 2026.
Egetis’ investigational drug Emcitate® (tiratricol) has been granted Rare Pediatric Disease Designation by the FDA, which makes Egetis eligible to receive a Priority Review Voucher (PRV), upon approval. As previously announced, Egetis completed its rolling U.S. New Drug Application (NDA) submission on January 29, 2026 and expects a regulatory decision from the FDA in September 2026.
FDA’s PRV program, established in 2012 and subsequently reauthorized in 2017 and 2020, is designed to stimulate the development of therapies for conditions that typically receive limited research investment, including rare pediatric diseases. Through the program, a company that obtains FDA approval for an eligible therapy is awarded a voucher that can be used to secure priority review for a future NDA or Biologics License Application (BLA). Priority review shortens the FDA’s standard review period from ten months to approximately six months. PRVs are transferable and can be sold to other companies, creating an active secondary market for these vouchers. In 2025 PRVs were sold for $150-$200 million per voucher.
