Sarepta to use commercial process material for next study of DMD gene therapy

Sarepta Therapeutics (NASDAQ:SRPT) reports that it has received a written response from the FDA’s Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies (OTAT) concerning its request to use commercial process material for the next clinical trial for SRP-9001, its investigational gene transfer therapy for Duchenne muscular dystrophy (DMD).

OTAT requested that the company use an additional potency assay for release of SRP-9001 commercial process material prior to dosing in a clinical trial. It has several existing assays and data that it believes could be used to satisfy OTAT, but additional dialogue is needed for division sign-off.

Sarepta will update investors as appropriate.

https://seekingalpha.com/news/3612803-sarepta-to-use-commercial-process-material-for-next-study-of-dmd-gene-therapy-srpominus-9001