SK Biopharm's Opakalim faces partial FDA clinical hold

The US Food and Drug Administration (FDA) has issued a partial clinical hold on the Phase 2 and 3 clinical trials for Opakalim (BHV-7000), an epilepsy drug candidate being developed by Biohaven Bioscience. SK Biopharm, which recently signed a licensing agreement with Biohaven for the global development and commercialization rights of Opakalim, was notified of the decision.

The hold was triggered after non-clinical toxicity tests showed toxicity in a specific metabolite when administered to mice. The FDA has requested additional non-clinical data to determine if this toxicity is a species-specific phenomenon limited to rodents or if it poses a risk to humans.

As a partial hold, the restriction applies only to the enrollment of new patients in the RISE2 and RISE3 trials; current patients already receiving the drug may continue their treatment. The RISE3 trial, which has already completed patient enrollment and randomization, is expected to remain unaffected, with top-line results still anticipated in the second half of 2026.

SK Biopharm noted that the toxicity findings were reviewed during their due diligence process prior to the licensing agreement, which is valued at up to $795 million. The company is currently coordinating with Biohaven as they prepare to submit the requested data to the FDA to lift the hold.