Company: SRPT
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0000950170-25-103971
Chunk: 6

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Part I, Item 2
Chunk 6
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 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 seeking to discuss with the FDA in 2025 a SRP-9003 biologics license application (“BLA");

•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; 

•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 molecular targets or selected disease indications and our ability to selectively pursue opportunities to access certain intellectual property rights that complement our internal portfolio through license agreements or other arrangements;