Sarepta Plans FDA Filings for Full Approval of DMD Therapies

Sarepta Therapeutics plans to submit supplementary new drug applications to the FDA for its RNA-based therapies, Amondys 45 and Vyondys 53, by the end of next month. The filings seek to convert the therapies' accelerated approval into full approvals. The FDA will evaluate the totality of evidence, including clinical and real-world data, to determine whether the therapies meet the requirements for traditional approval. The company's stock has plunged nearly 78% in the past year, and investors are awaiting the outcome of the FDA's evaluation.