Biohaven Stock Surges 20% as FDA Cancels Key Meeting

Biohaven Pharmaceutical Holdings Ltd. (Biohaven) experienced a significant pre-market surge following the cancellation of a scheduled advisory committee meeting by the U.S. Food and Drug Administration (FDA) regarding its core drug, troriluzole. The FDA had initially planned to convene an advisory committee to discuss Biohaven's New Drug Application (NDA) for troriluzole, which is intended to treat spinocerebellar ataxia, a rare neurodegenerative disease. The cancellation of this meeting suggests a positive development in the regulatory review process for troriluzole.

The FDA had granted Biohaven's NDA for troriluzole priority review status at the beginning of the year. This designation is typically reserved for drugs that address unmet medical needs or offer significant improvements over existing treatments. In May, the FDA's Neuroscience Office extended the review period to assess additional materials submitted by Biohaven in response to regulatory queries. The decision to hold an advisory committee meeting was part of this extended review process.

However, in a filing with the U.S. Securities and Exchange Commission (SEC) on Friday, Biohaven disclosed that the FDA had notified the company on August 21 that an advisory committee meeting was no longer necessary. This notification indicates that the FDA may have sufficient information to make a decision on the NDA without the need for further advisory input. Biohaven remains optimistic about the regulatory timeline, expecting the FDA to make a final decision on the NDA by the fourth quarter of 2025.

Biohaven is an independent entity that was spun off from Biohaven Pharmaceutical after the latter was acquired by Pfizer in 2022. The spin-off allowed Biohaven to focus on its core pipeline, including troriluzole, which has shown promise in treating spinocerebellar ataxia. The cancellation of the advisory committee meeting is a positive development for Biohaven, as it suggests that the regulatory review process is progressing smoothly. Investors have responded positively to this news, driving up the stock price in pre-market trading.