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New CEOMichael Severino, MD, brings extensive biopharma leadership and a proven track record of advancing innovation, building franchises, and delivering growth
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Net product revenues for the second quarter 2026 totaled$328.7 million, consisting of$230.6 millionof PMO net product revenue and$98.1 millionof ELEVIDYS net product revenue
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Achieved GAAP and non-GAAP operating income of$13.3 millionand$86.5 millionfor the second quarter 2026, respectively
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 5, 2026--Sarepta Therapeutics, Inc.(NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the second quarter of 2026.
“As I begin my tenure as CEO, I am excited by the strength of Sarepta's foundation, the impact our therapies are having for patients, and the significant opportunities ahead,” saidMichael Severino, MD, chief executive officer,Sarepta Therapeutics. “Our second quarter results, including$328.7 millionin total net product revenue and both GAAP and non-GAAP operating profitability, reflect the strength and resilience of our business. With important data readouts expected in DM1 and FSHD, continued progress across our broader pipeline, and a talented team dedicated to transforming the lives of patients with rare diseases, we have significant opportunities ahead and remain committed to delivering sustainable long-term value. Our priorities are clear: execute our commercial strategy, advance our promising siRNA pipeline, and continue allocating capital with discipline. With a strong balance sheet, an innovative pipeline, and an experienced leadership team, I believe Sarepta is well positioned to deliver on its long-term potential.”
Corporate Highlights:
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Leadership transition positions Sarepta for continued execution and next phase of growth: Appointed Michael Severino, MD, as Chief Executive Officer and member of the Board of Directors, effective July 28, 2026.Dr. Severino brings more than 25 years of biopharmaceutical leadership experience, including senior executive roles at AbbVie, Amgen and Merck, and a proven track record of advancing innovation, building leading franchises and executing across the full development and commercialization continuum. Doug Ingram retired from Sarepta and will serve in an advisory capacity through the end of 2026 to support a seamless leadership transition.
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Key 2H 2026 milestones update: Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026. For ELEVIDYS, full enrollment of ENDEAVOR Cohort 8 expected by year-end 2026 and 12-week data from the full cohort in Q1 2027.
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Huntington’s disease program advances: Dosing underway in INSIGHTT, the first-in-human Phase 1 study of SRP-1005, Sarepta’s investigational siRNA candidate for Huntington’s disease.
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Regulatory progress for PMO therapies: FDA has accepted for review Sarepta’s supplemental New Drug Applications (sNDAs) seeking conversion of AMONDYS 45 and VYONDYS 53 from accelerated to traditional approval. The applications are supported by data from the ESSENCE confirmatory study, substantial published real-world evidence, and the favorable, consistent safety profiles of both exon-skipping therapies.
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Narrowed FY 2026 Guidance: With six months remaining for the year and consistent with prior expectations toward the lower end of the $1.2-$1.4 billion range, Company narrowed its 2026 total net product revenue guidance to $1.2-$1.3 billion while also narrowing combined non-GAAP R&D and SG&A expense guidance from $800.0-$900.0 million to $800.0-$850.0 million.
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Strong financial position supports advancement of our pipeline and funding of medium-term liabilities: Delivered another quarter of operating profitability and ended with approximately $945.0 million of cash, cash equivalents, restricted cash and investments, an increase of approximately $197.0 million in the quarter. Company is well-positioned to advance DM1 and FSHD programs with commercial cash flows while maintaining disciplined capital allocation.
About EXONDYS 51
EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion, or “skipping”, of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
EXONDYS 51 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
About VYONDYS 53
VYONDYS 53 (golodirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 53 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
VYONDYS 53 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
About AMONDYS 45
AMONDYS 45 (casimersen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 45 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
AMONDYS 45 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
