Biohaven drops after FDA extends review period for genetic disease drug

Biohaven

15/05/2025 15:26

Updates

** Shares of drugmaker Biohaven BHVN.N fall 15.3% to a near 2-year low of $16.58

** Late on Wednesday, co said the US FDA extended the review period of the marketing application for its genetic disease drug, troriluzole, by three months

** FDA's decision is now expected in fourth quarter of the year, co says

** No new safety concerns were raised by the FDA - BHVN

** FDA planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled, co says

** Earlier this month, the FDA extended review date of Cytokinetics's CYTK.O heart disease drug aficamten by three months, as well

** Brokerage RBC said that the extension could be due to "staffing shortages at the agency" or FDA reviewers being "more skeptical" of BHVN's application

** The Trump administration's mass firings at the FDA, totaling 3,500 employees, have raised concerns about the agency's ability to review new medicines

** As of last close, stock down 47.4% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com))