Biohaven Stock Hits 52-Week Low, Cuts R&D Spending After FDA Rejection

Core Viewpoint - Biohaven Ltd. (NYSE:BHVN) experienced a significant decline in stock price, reaching a 52-week low following the FDA's Complete Response Letter regarding its New Drug Application for Vyglxia (troriluzole) for spinocerebellar ataxia [1][7]. Group 1: FDA Response and Study Findings - The FDA issued a Complete Response Letter (CRL) citing concerns related to real-world evidence and external control studies, including potential biases and design flaws [2]. - Biohaven believes that the statistical significance and clinical meaningfulness achieved in their study met the criteria for a "large and robust treatment effect," despite the FDA's concerns [4]. Group 2: Strategic Adjustments and Financial Outlook - Biohaven is implementing a strategic portfolio and cost optimization plan, aiming for a 60% reduction in annual direct R&D expenses and may pause non-priority programs to extend its cash runway [5]. - Analysts have downgraded Biohaven from Outperform to Market Perform, highlighting risks related to funding the development of its prioritized pipeline and the need for additional capital [6][7].