Annual financial reports and earnings releases from Sarepta Therapeutics

Sarepta's Elevidys Gains FDA Approval, Stock Soars 30%, BofA Raises Target to $213

Jun 21, 2024, 09:43 AM

Sarepta Therapeutics (SRPT) has received FDA approval for the expanded label of its gene therapy drug Elevidys, now approved for patients aged four years and older who are ambulatory and have a mutation in the DMD gene. This approval, which was driven by CBER Director Peter Marks despite opposition from FDA reviewers, has led to a significant increase in Sarepta's stock price, which rose by 30% following the news. Analysts have responded positively, with several firms raising their price targets for Sarepta, including BofA to $213, Baird to $200, Barclays to $226, and Needham to $235. The approval is expected to generate substantial revenue, with projections of $700 million annually by 2025-2026. Sarepta's CEO Doug Ingram highlighted the strong demand anticipated from patients and their families, estimating that 15,000 patients could benefit from the therapy. The decision has been seen as a major win for DMD patients, providing a new treatment option for this debilitating disease.