Biohaven Shares Surge After FDA Drops Advisory Committee Meeting, Analysts Expect Significant Upside

Biohaven (BHVN) shares surged after the FDA canceled an advisory committee meeting regarding its lead drug, troriluzole, for spinocerebellar ataxia. Analyst consensus gives BHVN an "Outperform" rating, with a significant average target price of $45.92, suggesting a 212.83% upside potential. The FDA decision is expected in Q4 2025.

Biohaven Ltd. (NYSE: BHVN) stock experienced a significant increase on Friday, following the U.S. Food and Drug Administration (FDA) decision to cancel an advisory committee meeting regarding its lead drug, troriluzole, for spinocerebellar ataxia (SCA). The FDA previously planned to hold the meeting to discuss the New Drug Application (NDA) for troriluzole, but it has since determined that such a meeting is no longer necessary for regulatory decision-making [1].

The FDA's decision to cancel the advisory committee meeting comes after Biohaven announced in May 2025 that the agency had extended the Prescription Drug User Fee Act (PDUFA) date by three months to allow for a comprehensive review of the company’s recent data submissions [2]. This extension was initially intended to facilitate a full review of Biohaven’s submissions and the subsequent advisory committee meeting.

Despite the cancellation of the advisory committee meeting, the FDA’s timeline for making a decision on the troriluzole NDA remains unchanged. The FDA expects to make a ruling on the application during the fourth quarter of 2025. If approved, troriluzole would represent the first and only FDA-approved treatment for SCA, a rare genetic disorder that affects approximately 15,000 people in the United States and 24,000 in Europe and the United Kingdom [1].

The cancellation of the advisory committee meeting has been well-received by investors, with Biohaven’s stock price surging by 11.65% to $16.40 premarket on Friday. Analyst consensus gives Biohaven an "Outperform" rating, with a significant average target price of $45.92, suggesting a 212.83% upside potential [1].

References:
[1] https://finance.yahoo.com/news/biohaven-advances-toward-potential-first-131412222.html
[2] https://www.investing.com/news/stock-market-news/biohaven-stock-rises-after-fda-drops-advisory-committee-plan-for-troriluzole-93CH-4206561