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Biohaven drops after FDA extends review period for genetic disease drug

ReutersMay 15, 2025 9:21 AM

Drugmaker Biohaven's BHVN.N shares fall 11.6% to $17.39 premarket

Co says the US FDA has extended review period of its 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 3 months, as well

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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