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Egetis says FDA sets Sept. 28 PDUFA date for Emcitate in MCT8 deficiency

PUBT·08/26/2026 08:05:03
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Egetis says FDA sets Sept. 28 PDUFA date for Emcitate in MCT8 deficiency
  • 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.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Egetis Therapeutics AB (publ) published the original content used to generate this news brief on August 26, 2026, and is solely responsible for the information contained therein.