Aug. 27 Quick Takes: Priority Review for casimersen in DMD, tepotinib in NSCLC; plus asciminib meets in CML and a farewell to digital pioneer Proteus

Priority Review for Sarepta’s casimersen

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA granted Priority Review to its BLA for Amondys 45 casimersen to treat Duchenne muscular dystrophy amenable to exon 45 skipping. Its PDUFA date is Feb. 25, 2021. The company said FDA does not currently plan to convene an advisory committee meeting to discuss the application. About 8% of DMD patients are exon 45-amenable; Sarepta’s marketed exon-skipping therapies Exondys 51 eteplirsen and Vyondys 53 golodirsen are intended for populations that account for about 13% and 8% of DMD patients, respectively...