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- Net product revenues for the first quarter 2026 totaled $330.5 million, consisting of $102.0 million of ELEVIDYS net product revenue and $228.6 million of PMO net product revenues<\/i><\/b><\/li>\n
- Achieved GAAP and non-GAAP operating income of $358.4 million and $397.7 million for the first quarter 2026, respectively<\/i><\/b><\/li>\n
- siRNA pipeline delivers first Phase 1\/2 data for SRP-1001 (FSHD1) and SRP-1003 (DM1) showing dose-dependent drug exposure, early biomarker effects, and favorable tolerability<\/i><\/b><\/li>\n
- Completed submission of sNDA for AMONDYS 45 and VYONDYS 53 to FDA seeking conversion to traditional approval<\/i><\/b><\/li>\n<\/ul>\n
CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nSarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the first quarter 2026.<\/p>\n\n“We entered 2026 with clear priorities\u2014stabilizing the business, restoring growth, maintaining financial strength, and advancing a pipeline that we believe can define Sarepta\u2019s next era. In the first quarter, we made meaningful progress against each,\u201d said Doug Ingram, chief executive officer, Sarepta Therapeutics. \u201cOur commercial portfolio has begun to stabilize, supported by expanded field engagement and a growing body of evidence reinforcing the disease\u2011modifying impact of ELEVIDYS, which we believe is positioned to return to growth. At the same time, we are advancing Cohort 8 of the ENDEAVOR study with sirolimus pretreatment to serve our goal of once again making ELEVIDYS available to the non\u2011ambulatory community. Finally, we remain in a position of financial strength, with positive earnings, and continued cash flow generation that enables us to fully fund our pipeline. Our potentially best\u2011in\u2011class clinical\u2011stage siRNA portfolio continues to advance, with encouraging early signals in DM1 and FSHD and multiple upcoming readouts across high\u2011value programs.\u201d<\/p>\n
Corporate Highlights:<\/i><\/b><\/p>\n
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- First Clinical Data from siRNA Pipeline Targeting FSHD1 and DM1:<\/b> In March 2026, Sarepta shared early clinical results from Phase 1\/2 ascending dose studies of SRP-1001 for facioscapulohumeral muscular dystrophy type 1 (FSHD1) and SRP-1003 for myotonic dystrophy type 1 (DM1). The data demonstrated consistent dose-dependent increases in drug exposure, early biomarker effects, and favorable tolerability without dose-limiting safety signals, reinforcing the potential of the \u03b1v\u03b26 integrin-targeted delivery platform.\n<\/li>\n
- ENDEAVOR Cohort 8 Enrollment and Dosing underway<\/b>: In March 2026, the Company announced that screening and enrollment are underway for approximately 25 non-ambulatory participants in Cohort 8 of the ENDEAVOR study (Study 9001-103), and as of April 2026 dosing has also begun. This cohort will assess prophylactic sirolimus as part of an enhanced immunosuppressive regimen designed to mitigate the risk of acute liver injury associated with AAV gene therapy in older patients with more advanced Duchenne muscular dystrophy.\n<\/li>\n
- ELEVIDYS First commercial sale in Japan<\/b>: In March 2026, following commercial launch of ELEVIDYS in Japan by Chugai Pharmaceuticals, Sarepta earned a $40.0 million milestone payment under the Roche collaboration agreement.\n<\/li>\n
- Regulatory pathway advances for PMO therapies<\/b>: In April 2026, Sarepta submitted sNDAs seeking to convert AMONDYS 45 and VYONDYS 53 from accelerated to traditional approvals, supported by ESSENCE confirmatory study data and substantial real-world evidence.\n<\/li>\n
- Strong first quarter of 2026 financial performance<\/b> deliveringGAAP and Non-GAAP operating profit. Underlying operations were cash flow positive when excluding planned Arrowhead collaboration payments and enables self\u2011funded pipeline advancement.\n<\/li>\n
- Reiterate FY 2026 guidance: <\/b>Total net product revenues of $1.2 – $1.4 billion, and combined non-GAAP R&D and SG&A expenses of $800.0 – $900.0 million.\n<\/li>\n<\/ul>\n
Conference Call<\/i><\/b><\/p>\n
\nThe event will be webcast live under the investor relations section of Sarepta’s website at https:\/\/investorrelations.sarepta.com\/events-presentations<\/b><\/a> and following the event a replay will be archived there for one year. This event can be accessed using this link<\/b><\/a>.<\/b><\/p>\n
Q1 2026 Financial Highlights1<\/sup><\/i><\/b><\/p>\n
- ENDEAVOR Cohort 8 Enrollment and Dosing underway<\/b>: In March 2026, the Company announced that screening and enrollment are underway for approximately 25 non-ambulatory participants in Cohort 8 of the ENDEAVOR study (Study 9001-103), and as of April 2026 dosing has also begun. This cohort will assess prophylactic sirolimus as part of an enhanced immunosuppressive regimen designed to mitigate the risk of acute liver injury associated with AAV gene therapy in older patients with more advanced Duchenne muscular dystrophy.\n<\/li>\n
- Achieved GAAP and non-GAAP operating income of $358.4 million and $397.7 million for the first quarter 2026, respectively<\/i><\/b><\/li>\n
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