FDA Places Partial Hold on BHV-7000 Trials

The FDA has placed a partial clinical hold on Biohaven’s and SK Biopharm’s Phase 2/3 trials of BHV-7000, an epilepsy drug candidate also known as opacalim or OPCALIM, after toxicity was observed in a metabolite study involving rodents. Existing participants may continue treatment, but enrollment in the affected studies is paused while Biohaven conducts additional nonclinical work to determine whether the finding is specific to rodents and poses a risk to humans. RISE3 has completed enrollment and randomization, so the companies said they still expect to report topline results in the second half of 2026, while no related adverse events have been identified among more than 1,200 clinical-trial participants. The hold comes shortly after SK Biopharm agreed to license the drug for $350 million upfront, plus additional payments, although both companies said the toxicity data had been disclosed and reviewed during due diligence before the deal.