Biohaven falls as US FDA rejects rare nerve disease drug application

Biohaven

05/11/2025 10:14

** Shares of drugmaker Biohaven BHVN.N fall 45% to $7.72 premarket

** Co says U.S. FDA has rejected its application to approve troriluzole, a drug for spinocerebellar ataxia (SCA), a rare inherited brain disorder that causes loss of movement and has no approved treatments

** The FDA in its so-called complete response letter (CRL) said it was concerned about the design and reliability of co's main study for troriluzole, citing bias and flaws in real-world data used instead of standard trial methods

** BHVN says troriluzole slowed disease progression and reduced fall risk in trials

** BHVN to meet U.S. FDA to discuss future path for approval, co says

** Up to last close, stock down ~63% YTD

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))