SK Biopharmaceuticals said it will close its licensing transaction for Biohaven's epilepsy candidate Opakalim only after an FDA partial clinical hold is resolved. Yoo Chang-ho, head of strategy at SK Biopharmaceuticals, said Biohaven plans to submit requested data between late September and early October, with a final resolution anticipated between October and November. The hold suspends new enrollment in the Phase 2 RISE2 trial after rodent testing of a specific Opakalim metabolite raised toxicity questions, but more than 600 enrolled patients can remain on treatment. Phase 3 RISE3 enrollment was completed in June, preserving the planned release of topline results in the second half of this year. SK Biopharmaceuticals has signed the Biohaven agreement but has not paid its upfront fee. Separately, Novartis reported that del-desiran missed a Phase 3 endpoint in myotonic dystrophy type 1, while AstraZeneca and Amgen reported improved overall survival for Imfinzi plus Imdelltra in extensive-stage small cell lung cancer.