Biohaven Ltd. has announced that the FDA is extending the PDUFA date for the new drug application (NDA) of troriluzole, aimed at treating spinocerebellar ataxia $(SCA)$, by three months to allow for a comprehensive review of recent submissions from the company. This decision pushes the expected announcement to the fourth quarter of 2025. Troriluzole, which has already been granted Fast-Track, Orphan Drug Designation, and Priority Review by the FDA, would be the first and only FDA-approved treatment for the rare, genetic, and life-threatening neurodegenerative disease if approved. The FDA has not raised any new concerns and is planning an advisory committee meeting to discuss the application, though the date has not been set.
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