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新药上市遭FDA拒批,Biohaven(BHVN.US)股价暴跌40%!美银下调评级至“中性”
智通财经网· 2025-11-06 02:17
Core Viewpoint - Biohaven's stock plummeted by 40.22% to a 52-week low following the FDA's complete response letter (CRL) rejecting the approval of its main asset, Vyglxia (troriluzole) [1] Group 1: FDA Response and Market Reaction - The FDA issued a CRL for Biohaven's new drug application (NDA) for Vyglxia, which targets spinocerebellar ataxia, a rare neurodegenerative disease [1] - The stock downgrade by Bank of America from "Buy" to "Neutral" and the target price reduction from $49 to $10 reflects the negative market sentiment following the FDA's decision [1] - Biohaven's CEO expressed disappointment over the FDA's decision, indicating the company's commitment to continue discussions with the FDA regarding the drug's regulatory pathway [1] Group 2: Company Restructuring and Financial Implications - Biohaven announced a restructuring plan that includes pausing or delaying non-priority R&D projects, aiming for a 60% reduction in annual R&D spending [2] - Analyst Jason Gerberry expressed caution regarding the restructuring plan, suggesting it may limit resource allocation to the company's three core assets, including Kv7 ion channel activator Opakalim [2] - The valuation model has been adjusted to exclude projections related to troriluzole due to the uncertainty surrounding its approval [2]