Biohaven rises as FDA cancels AdCom on lead drug

[FDA headquarters in Washington DC.]
JHVEPhoto

Biohaven (NYSE:BHVN [https://seekingalpha.com/symbol/BHVN]) shares spiked in the premarket on Friday after the FDA revoked an advisory committee meeting scheduled in connection with its marketing application for lead drug troriluzole.

Early this year, the New Haven, Connecticut-based biotech received the FDA’s priority review for its new drug application (NDA) for troriluzole targeted at spinocerebellar ataxia, a group of rare neurodegenerative disorders.

In May, the FDA’s Office of Neuroscience extended its review period to evaluate additional submissions made by the company in response to the agency’s requests and decided to hold an advisory committee meeting to discuss the NDA. [https://seekingalpha.com/news/4448631-biohaven-stock-slides-fda-delays-drug-review]

In an SEC filing on Friday, the company noted that the FDA informed it on Aug. 21 that an AdCom meeting is no longer required for the review.

Biohaven (NYSE:BHVN [https://seekingalpha.com/symbol/BHVN]), a spinout of Biohaven Pharmaceutical formed when Pfizer (PFE [https://seekingalpha.com/symbol/PFE]) acquired the migraine therapy maker in 2022, continues to expect a decision on the NDA in Q4 2025.

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* Seeking Alpha’s Quant Rating on Biohaven [https://seekingalpha.com/symbol/BHVN/ratings/quant-ratings]
* Historical earnings data for Biohaven [https://seekingalpha.com/symbol/BHVN/earnings]
* Financial information for Biohaven [https://seekingalpha.com/symbol/BHVN/income-statement]