Egetis Wins FDA Priority Review for Emcitate as EU Launch Gathers Pace
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Egetis Therapeutics AB has received FDA Priority Review for its New Drug Application for Emcitate (tiratricol) to treat MCT8 deficiency, with a target action date of September 28, 2026. The company is also advancing its EU commercialization efforts, reporting a 9% revenue increase in Europe. Egetis has strengthened its intellectual property with a U.S. composition patent expected to be valid through 2045. Despite a quarterly loss, the company raised SEK 350 million through a share issue and is focusing on pricing and reimbursement processes in Germany, Italy, and France.
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