2023-05-24 08:22:51 ET
- Sarepta Therapeutics ( NASDAQ: SRPT ) announced Wednesday that the FDA would require additional time to review its marketing application for SRP-9001, a gene therapy targeted at certain patients with Duchenne muscular dystrophy (DMD).
- The announcement comes days after an FDA advisory committee endorsed the accelerated approval for SRP-9001, for which Sarepta ( SRPT ) has partnered with Catalent ( CTLT ) for production.
- While the FDA is not required to follow the recommendation of experts, the regulator usually considers their opinion before making a final decision which, in the case of the Biologics License Application (BLA) for SRP-9001, was due before May 29, 2023.
- SRPT said the FDA has required “modest additional time” to complete the review regarding requirements such as certain labeling and post-marketing commitment discussions. The company added that the regulator expects to complete the review by June 22, 2023.
- Sarepta ( SRPT ) shares lost ~14% in the pre-market, while Catalent ( CTLT ) has shed ~2% . Roche ( OTCQX:RHHBY ) ( OTCQX:RHHBF ), which has partnered with Sarepta ( SRPT ) for the commercialization of SRP-9001 in overseas markets, is trading flat.
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Sarepta says FDA needs more time to review muscular dystrophy drug