Biohaven

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Sponsor of BHV-7000 trials;under partial FDA hold

Nine days after Biohaven signed a licensing deal worth up to $795 million with SK Biopharmaceuticals for its epilepsy drug platform, the FDA halted new enrollment in the drug's two late-stage trials. The hold came not because BHV-7000 (opakalim) showed safety problems in humans—over 1,200 people have taken it and tolerability has been generally clean—but because a metabolite found in rat studies raised questions the agency couldn't fully assess. Biohaven says the finding's significance to people is uncertain and may be rodent-specific.

Updated 2 hours ago