The FDA placed a partial clinical hold on Biohaven’s epilepsy drug opakalim shortly after the company sold rights to the therapy, according to the report. The halt affects a study analysts say may be important for supporting a potential approval. Separate reporting also describes an FDA partial clinical hold on Biohaven’s ion channel program BHV-7000, where regulators requested additional preclinical safety information. In both cases, the near-term consequence for investors and competitors is schedule uncertainty—especially for development plans that depend on enrolling and completing additional cohorts to close regulatory evidence gaps. Teams will be watching how quickly Biohaven can respond with the requested safety package and whether the holds broaden to additional studies.