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Biohaven drops after FDA extends review period for genetic disease drug

ReutersMay 15, 2025 2:26 PM

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

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