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Investing.com -- Biohaven Ltd. (NYSE:BHVN) stock rose 3% Friday morning after the company announced that the U.S. Food and Drug Administration (FDA) no longer plans to hold an advisory committee meeting for its troriluzole drug application.
The FDA had previously informed Biohaven that it would convene an advisory committee to discuss the New Drug Application (NDA) for troriluzole, which is being developed to treat adult patients with Spinocerebellar Ataxia (SCA). However, on August 21, the regulatory agency communicated that such a meeting "is no longer needed for regulatory decision making," according to a company SEC filing.
Despite this change, the FDA’s timeline for making a decision on the application remains unchanged, with an expected ruling during the fourth quarter of 2025. The agency had previously extended the Prescription Drug User Fee Act (PDUFA) date by three months to allow for a full review of Biohaven’s recent submissions related to information requests.
The PDUFA extension was announced in May 2025, when the FDA’s Division of Neurology 1 indicated it needed additional time to review information submitted by Biohaven. At that time, the agency had also informed the company of its intention to hold the advisory committee meeting that has now been deemed unnecessary.
Troriluzole represents an important potential treatment option for patients with Spinocerebellar Ataxia, a rare genetic disorder that affects movement and can cause progressive problems with coordination and balance.
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