NasdaqGS:SRPTBiotechs
Will FDA Liver Warning and Newborn Screening Expansion Change Sarepta Therapeutics' (SRPT) Risk‑Reward Narrative?
Sarepta Therapeutics recently executed a convertible notes exchange to ease near-term refinancing pressure and extend its cash runway, while the FDA updated the label for its gene therapy ELEVIDYS with a boxed warning for acute liver injury and restricted use to ambulatory Duchenne muscular dystrophy patients, and also cleared a new ENDEAVOR study cohort to test an enhanced immunosuppressive regimen.
In parallel, the U.S. Department of Health and Human Services’ decision to add Duchenne...