Company: SRPT
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001193125-25-269436
Chunk: 4

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 4
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 coverage by insurance company;

•the estimated impacts of the strategic restructuring plan announced in July 2025;

•our expectation that our partnership with Catalent, Inc. (“Catalent”) will support our clinical and commercial manufacturing demand for our Duchenne gene therapy program and SRP-9003 LGMD program, while also acting as a manufacturing platform for potential future gene therapy programs;

•our expectation that Aldevron LLC (“Aldevron”) will provide Good Manufacturing Processes (“GMP”)-grade plasmid for our Duchenne gene therapy program and our SRP-9003 LGMD program, as well as plasmid source material for any future gene therapy programs;

•the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business as well as the development of our product candidates and our financial and contractual obligations;

•estimated timelines and milestones for the remainder of 2025 and beyond, including discussions with the FDA regarding ELEVIDYS, VYONDYS, AMONDYS and SRP-9003, and sharing data for certain of the Company's siRNA product candidates, SRP-1001 and SRP-1003, in 2026;

•our engagement with regulatory authorities outside of the U.S. including the European Medicines Agency (the “EMA”); 

•our plan to continue building out our network for commercial distribution in jurisdictions in which our products are approved or in which we are seeking approval for our products; 

•our plan to expand our pipeline through internal research and development and through strategic transactions; 

•the timely completion and satisfactory outcome of our post-marketing requirements and commitments, including verification of a clinical benefit for our products in confirmatory trials;

•our ability to further secure long-term supply of our commercial products and our product candidates to satisfy our planned commercial, early access programs (“EAP”) and clinical needs; 

•the possible impact of any executive, legislative or regulatory action and competing products on the commercial success of our products and our product candidates and our ability to compete against such products; 

•our ability to enter into research, development or commercialization alliances with universities, hospitals, independent research centers, non-profit organizations, pharmaceutical and biotechnology companies and other entities for specific