[REVISION HISTORY]

SK Biopharm Opakalim licensing and clinical development

Updated 1 time since CLSTR started tracking revisions of this situation.

What changed

2026-09-11 01:11 UTC → 2026-09-12 01:46 UTC · added ~~removed~~

SK Biopharm entered an exclusive worldwide licensing agreement with Biohaven Bioscience Ireland for the epilepsy drug candidate Opakalim (BHV-7000) and its Kv7 Discovery Platform. The deal, valued at up to $795 million, includes a $400 million upfront payment and potential milestone payments of up to $395 million. Under the agreement, Biohaven manages ongoing Phase 2 and Phase 3 clinical trials while SK Biopharm covers the costs. Following the deal, the US Food and Drug Administration (FDA) issued a partial clinical hold on the RISE2 and RISE3 trials for Opakalim. The hold was prompted by non-clinical toxicity tests in mice that showed toxicity in a specific metabolite. The FDA has requested further data to determine if this risk extends to ~~humans.~~ humans or is a “species-specific phenomenon limited to rodents.” The partial hold restricts the enrollment of new patients, though current patients may continue treatment. The RISE3 trial, which has completed enrollment, is expected to proceed with top-line results anticipated in the second half of 2026. SK Biopharm stated that these toxicity findings were reviewed during their due diligence process prior to the licensing agreement. Following the FDA announcement, Biohaven Ltd. experienced a significant drop in its share price, falling approximately 15%. Consequently, the company is facing a new securities investigation by Levi & Korsinsky LLP. Biohaven expects to provide additional animal study data to the FDA in the coming weeks to address the concerns regarding the metabolite.

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