FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure

FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies.

The pause follows the drug's failure to demonstrate efficacy in a mid-stage depression trial last year, adding to a series of setbacks for the company.

Biohaven previously saw the FDA reject its spinocerebellar ataxia therapy, troriluzole, in November 2025, prompting a 60% cut to its R&D budget and a sharp share decline.

The agency requires additional non-clinical data on a metabolite identified in rodent studies before enrollment can resume, while the company continues dosing existing participants.