The FDA has placed Biohaven’s epilepsy candidate opakalim on a partial clinical hold, affecting a study that some observers see as important for establishing a path to approval after the company sold off rights to the therapy. Separately, Biohaven disclosed another FDA partial hold on an ion channel program, BHV-7000, pausing enrollment after the agency asked for additional information related to rodent preclinical safety findings. Together, the actions show regulators tightening scrutiny across multiple programs. For investors and clinicians watching Biohaven, the holds increase timeline uncertainty and raise the importance of aligning preclinical safety packages with FDA expectations before resuming trials.