Sarepta Says Statistically Significant Results On All Key Pre-specified Secondary Endpoints Demonstrated Evidence Of Clinically Meaningful Treatment Benefit
Portfolio Pulse from Benzinga Newsdesk
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced topline results from EMBARK, a Phase 3 clinical study of ELEVIDYS in patients with Duchenne muscular dystrophy. The results showed statistically significant results on all key pre-specified secondary endpoints, demonstrating evidence of a clinically meaningful treatment benefit. The US FDA has indicated openness to reviewing the data for label expansion. Sarepta plans to host an investor call on October 30.
October 30, 2023 | 8:06 pm
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Sarepta Therapeutics announced positive results from a Phase 3 clinical study of ELEVIDYS, which could lead to label expansion. This could potentially increase the market for the drug, positively impacting the company's revenues.
The positive results from the EMBARK study demonstrate the efficacy of ELEVIDYS, which could lead to label expansion. This would increase the market for the drug, potentially leading to increased revenues for Sarepta. The FDA's openness to reviewing the data also indicates a positive regulatory environment for the company.
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