FDA Places Partial Hold on Biohaven’s Epilepsy Drug After $350 Million Licensing Deal

Biohaven said the FDA placed a partial clinical hold on trials of opakalim (BHV-7000), its experimental treatment for focal-onset epilepsy, on September 10, 2026.

The hold pauses enrollment of new participants while the FDA reviews safety information. Existing participants may continue under the agency’s conditions; available reports did not indicate that the drug’s development had been terminated.

The announcement came roughly two weeks after Biohaven agreed to license opakalim and its broader Kv7 platform to SK Biopharmaceuticals.

Under the deal, Biohaven is due $350 million at closing and another $50 million one year later. The agreement could be worth up to $795 million, including development and regulatory milestones, plus royalties.

Opakalim is being tested in Phase 2/3 studies, with pivotal RISE3 results previously expected in the second half of 2026. The FDA hold creates uncertainty around the trial timeline and the drug’s eventual approval prospects.