From Yahoo Finance: 2025-05-15 13:22:00

Biohaven Ltd. (NYSE: BHVN) shares plunged after the FDA delayed the review date for its rare-disease drug troriluzole by three months. Troriluzole could be the first FDA-approved treatment for spinocerebellar ataxia, affecting 15,000 in the U.S. and 24,000 in Europe. Biohaven CEO stated the drug slows disease progression by 50-70%.

The FDA did not raise new concerns but extended the decision date for Biohaven’s NDA to the fourth quarter of 2025. An advisory committee meeting is planned but no date set yet. Biohaven recently secured a $600 million capital agreement to support commercial launch planning and ongoing operations.

Analysts at William Blair find the delay surprising and note the uncertainty in the FDA regulatory landscape. Despite concerns, they reiterate an Outperform rating for Biohaven, expressing confidence in the drug’s approval. BHVN stock is down 14.3% at $16.85 in response to the news.



Read more at Yahoo Finance: Why Is Biohaven Stock Falling On Thursday?