Company: SRPT
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001193125-25-269436
Chunk: 12

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 4
Chunk 12
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The commercial success of our products continues to depend on, and the commercial success of any future products would depend on, a number of factors attributable to our products or the products of our competitors, including, but not limited to:  

•the effectiveness of our sales, managed markets, marketing efforts and support for our products;

•the generation and dissemination of new data and analyses and the consistency of any new data and analyses with prior results, whether they support a favorable safety, efficacy and effectiveness profile of our products and any potential impact on our FDA approval status and/or FDA package insert for our products, including our ongoing discussions with FDA for ELEVIDYS in response to incidents of ALF resulting in patient death;

•the effectiveness of our ongoing commercialization activities, including negotiating and entering into any additional commercial, supply and distribution contracts, ongoing manufacturing efforts and hiring any additional personnel as needed to support commercial efforts;

•our ability to timely comply with FDA post-marketing requirements and commitments, including through successfully conducting additional studies that confirm clinical efficacy, effectiveness and safety of our products, including our