Biohaven stock remains under pressure after FDA partial hold on opakalim epilepsy program
Biohaven’s opakalim program faces an FDA partial hold over a rodent metabolite, while a fully enrolled pivotal epilepsy study remains on track.
Biohaven’s opakalim program faces an FDA partial hold over a rodent metabolite, while a fully enrolled pivotal epilepsy study remains on track.
SK Biopharmaceuticals is acquiring worldwide rights to opakalim and Biohaven’s Kv7 platform, providing $400 million in near-term cash and assuming additional obligations while pivotal RISE3 data remain due in the second half of 2026.
Biohaven Ltd. has reported that BHV-7000, its experimental Kv7 ion channel modulator, failed to meet the primary endpoint in a Phase 2 proof-of-concept trial evaluating the drug in patients with major depressive disorder. The trial assessed changes in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale over six weeks compared to placebo. Although some numerical