FDA Halts Epilepsy Trials
FDA Places Partial Clinical Hold on Biohaven and SK Biopharm Epilepsy Trials
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Key Points
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The licensing agreement includes an additional $50 million payment due next year, up to $150 million in milestone payments, and requires SK Biopharmaceuticals to assume Biohaven’s obligations to Knopp Biosciences, the drug’s original developer.
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BHV-7000 is being evaluated as a selective activator of the Kv7.2/7.3 potassium channels for patients with focal epilepsy.
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The affected RISE trials are multicenter, randomized, double-blind and placebo-controlled studies designed to evaluate BHV-7000’s efficacy, safety and tolerability in patients with drug-resistant focal seizures.
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Biohaven expected to generate the additional nonclinical data needed to assess the metabolites’ potential human risk within several weeks and plans to submit it to the FDA to seek removal of the partial hold; lifting the hold will depend on the agency’s review.
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Biohaven’s program had selected more than 110 global clinical sites for its focal-epilepsy development program, with enrollment beginning in the first quarter of 2024 after an FDA End-of-Phase 2 meeting in January 2024.
The FDA has placed a partial hold on clinical trials of BHV-7000, an epilepsy drug being developed by Biohaven and SK Biopharm, after rodent studies showed toxicity in a drug metabolite IJR. New patient enrollment is paused, but the roughly 1,200 people already in trials can continue taking the drug. The companies said no adverse events have emerged in patients so far.
Biohaven expects to complete additional safety studies within weeks and submit findings to the FDA GuruFocus. The company still aims to report results from its main Phase 2/3 trial in the second half of 2026, as that study finished enrolling patients before the hold was announced TradingView.
Why the FDA Paused New Enrollments
The hold stems from toxicity findings in nonclinical metabolite studies using rodents IJR. The FDA wants Biohaven to determine whether this toxicity is unique to animals or could threaten human patients. Both companies disclosed this data during their merger discussions, they said, and the issue did not derail SK Biopharm's $350 million licensing deal GuruFocus.
Stock Slides as Investors React to Uncertainty
Biohaven shares dropped 15% to 16% on the news GuruFocus. The partial hold adds risk to a program that was moving quickly — the company had lined up over 110 clinical trial sites and began enrolling patients in early 2024 after an FDA green light GuruFocus.
What BHV-7000 Is Supposed to Do
BHV-7000, also called opacalim, is designed to activate potassium channels in the brain that may stop seizures IJR. It targets patients with drug-resistant focal epilepsy — seizures that don't respond to standard medications. The RISE trials are randomized, double-blind studies comparing the drug to placebo.
Path Forward: Weeks to Resolve the Hold
Biohaven plans to generate and submit the needed nonclinical data within several weeks TradingView. The FDA will then review whether the metabolite poses a real human risk. If the agency agrees the concern is limited to rodents, it can lift the partial hold and let new patients enroll GuruFocus. The main trial, RISE3, already finished enrolling and randomizing patients, so topline results remain on track for late 2026.
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