Biohaven Stock Plunges 11.5% on FDA NDA Delay

On May 15, 2025, Biohaven's stock experienced a significant drop of 11.5% in pre-market trading.

The FDA has extended the PDUFA date for Biohaven's Troriluzole NDA, which is intended for the treatment of Spinocerebellar Ataxia (SCA). This decision has caused uncertainty among investors, leading to a decline in the company's stock price. The FDA's decision regarding the NDA is now expected in the fourth quarter of 2025. Biohaven had previously received Fast-Track, Orphan Drug Designation (ODD), and Priority Review from the FDA for Troriluzole.

This extension has caused a significant decline in Biohaven's stock price, falling by 9%. The broader market session also saw a general downturn in U.S. equity futures. Meanwhile, movements in commodity prices were notable, with WTI Crude Oil decreasing by 1.8% and gold remaining relatively stable, despite both breaking previous trends.