SK Biopharmaceuticals

New Capabilities

Worldwide licensee of Biohaven's Kv7 platform;deal not yet closed as of hold date

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