SK Biopharmaceuticals announced that it has received a 'Partial Clinical Hold' notification from the U.S. Food and Drug Administration (FDA) concerning the Phase 2/3 clinical trials of its epilepsy drug candidate Opakalim (BHV-7000). The company received this notification from its partner Biohaven (Biohaven Bioscience Ireland Limited, hereinafter Biohaven) on September 10, 2026.

The Hold Applies to RISE2 and RISE3

According to the regulatory filing, the FDA notified Biohaven of a partial clinical hold on the multinational, randomized, double-blind, placebo-controlled Phase 2/3 clinical trials (RISE2, RISE3) evaluating the efficacy, safety, and tolerability of BHV-7000 in patients with drug-resistant partial-onset epilepsy.

The FDA requested additional nonclinical data to determine whether the toxicity observed in nonclinical toxicity studies, in which a specific metabolite of BHV-7000 was administered to rats, is species-specific (rodent).

Dosing Continues for Enrolled Patients…RISE3 Unaffected

Under this hold, patients currently receiving the drug may continue dosing. However, the enrollment of new patients is temporarily suspended until the additional nonclinical studies are completed.

In particular, the company stated that RISE3 has already completed patient enrollment and randomization, and is therefore unaffected by this notification.

Biohaven to Seek Lift of Hold Through Additional Nonclinical Studies

Biohaven is conducting additional nonclinical studies in response to the FDA's request. After obtaining the study results and supporting data, it plans to submit them to the FDA to pursue the lifting of the partial clinical hold. Whether and when the hold will be lifted is expected to depend on the FDA's review of the additional data submitted by Biohaven.

Contract Deal-Closing Not Yet Completed

This disclosure relates to the in-licensing agreement SK Biopharmaceuticals signed with Biohaven covering BHV-7000 and other potassium channel (Kv7) activator compounds, as well as the Kv7 Discovery Platform. As of the filing date on the 10th, the deal-closing of the contract has not been completed.

SK Biopharmaceuticals stated that it will promptly disclose any changes, such as the lifting of this partial clinical hold.