Egetis says FDA sets Sept. 28 PDUFA date for Emcitate in MCT8 deficiency
Reuters2026/08/26 08:05- Egetis Therapeutics spotlighted Emcitate (tiratricol), launched in Germany in May 2025 as the first EU-approved treatment for MCT8 deficiency.
- FDA accepted the Emcitate NDA on March 27, 2026 under Priority Review; PDUFA date set for Sept. 28, 2026.
- U.S. commercial launch targeted for Q4 2026; about 60 patients across 17 sites currently treated via expanded access.
- Cash position at June 30, 2026 was SEK 378 million following a SEK 350 million directed share issue; market cap about SEK 3.5 billion.
- Q2 2026 revenue totaled SEK 17.4 million; operating result was SEK -108.3 million as spending rose for U.S. launch preparation.
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