Sarepta Therapeutics (NASDAQ:SRPT) announced a temporary halt in recruitment and dosing for certain clinical studies of ELEVIDYS, their approved gene therapy for Duchenne muscular dystrophy. This follows a safety update on acute liver failure from March 18.
The independent data monitoring committee (DMC) reviewed the adverse event on April 3 and concluded that the overall benefit-risk profile remains favorable to continue dosing. The affected studies include SRP-9001-302 (ENVOL), SRP-9001-303 (ENVISION), and SRP-9001-104.
Sarepta and Roche will submit their response to EU regulators within a week. The company maintains that monitoring and data collection for already-enrolled participants continues, and they do not anticipate material impact on study timelines.
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