Company: SRPT
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-064412
Chunk: 8

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 2
Chunk 8
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 the remainder of 2025 and beyond, including submitting a SRP-9003 BLA in the second half of 2025;

•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 legislation 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;

•our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our plans and ability to file and progress to issue additional patent applications to enhance and protect our new and existing technologies and programs; 

•the potential benefits of our technologies and programs, including those with strategic partners;

•our estimates regarding how long our currently available cash and cash equivalents will be sufficient to finance our operations and business plans and statements about our future capital needs;