Why Is Biohaven Stock Soaring Today? - Biohaven (NYSE:BHVN)

Biohaven Ltd. shares jumped on Thursday, rising 31.36% to $15.43 at publication, after the company received an FDA update tied to its rare-disease program for spinocerebellar ataxia (SCA). Trading volume was 10.293 million shares versus an average of 2.585 million. The FDA accepted Biohaven’s resubmission of its new drug application for Vyglxia (troriluzole) in SCA for review, setting a user fee goal date in the first quarter of 2027. Biohaven said the resubmission included new supportive analyses and that the FDA considers it a complete response to a November 2025 action letter. The company also said the FDA plans an advisory committee meeting with a date to be announced, citing concerns that can be inherent to real-world evidence and external control studies. Earlier in September, the FDA issued a partial clinical hold on new patient enrollment for BHV-7000.