Shares of Biohaven Pharmaceutical Holding Co Ltd. (BHVN) tumbled 5.90% in after-hours trading on Wednesday, following an announcement that the U.S. Food and Drug Administration (FDA) has extended the review period for the company's New Drug Application (NDA) for troriluzole.
The FDA has pushed back the Prescription Drug User Fee Act (PDUFA) date for troriluzole, Biohaven's investigational treatment for spinocerebellar ataxia, a rare genetic disease. This extension shifts the expected decision timeline, with the FDA's ruling now anticipated in the fourth quarter of 2025, rather than the previously expected earlier date.
This delay in the regulatory process for troriluzole, a key drug in Biohaven's pipeline, has clearly rattled investors. The extended review period not only pushes back potential revenue from the drug but also introduces additional uncertainty into the approval process. For a pharmaceutical company, delays in drug approvals can significantly impact financial projections and market confidence, which is reflected in the sharp after-hours stock decline.
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