SRPT Stock Soars on Unveiling New Restructuring Plan, Pipeline Pivots
SRPT to Cut Costs & Focus on siRNA Pipeline
Sarepta's restructuring plan aims to save about $400 million annually starting in 2026. To achieve this target, the company has decided to lay off 36% of its workforce — around 500 employees — which is expected to save nearly $120 million per year. SRPT plans to generate around $300 million in annual savings by reprioritizing its pipeline.
Concerning the pipeline, Sarepta has decided to pause development of most of its gene-therapy candidates for limb-girdle muscular dystrophy (LGMD). The company, however, intends to move forward with SRP-9003, its gene therapy candidate for patients with LGMD type 2E/R4 (LGMD2E/R4, or beta sarcoglycanopathy). A regulatory filing with the FDA remains on track for this therapy before year-end.
SRPT has now shifted focus to its siRNA programs, which were acquired as part of a multi-billion-dollar licensing deal with Arrowhead Pharmaceuticals ARWR. After closing the Arrowhead deal in February, Sarepta acquired exclusive rights to four clinical-stage siRNA programs, each being evaluated in separate phase I/II studies. These include SRP-1001 in facioscapulohumeral muscular dystrophy (FSHD), SRP-1002 in idiopathic pulmonary fibrosis (IPF), SRP-1003 in myotonic dystrophy type 1 (DM1) and SRP-1004 in spinocerebellar ataxia 2 (SCA2).
Initial data from studies on SRP-1001 and SRP-1003 are expected before year-end. Sarepta also acquired three preclinical programs from Arrowhead, including SRP-1005 (for Huntington's disease), which is set to enter clinical development early next year.
While Sarepta expects to incur severance and one-time charges of $32 million to $37 million, it still anticipates saving over $100 million in annual costs this year. For full-year 2026, Sarepta expects the combined adjusted R&D and SG&A expenses to be in the range of $800-$900 million.
SRPT Stock Performance
Sarepta's motivation behind these moves is clear — this company-wide reorganization aims to address the setback stemming from safety concerns around Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). The latest surge in stock price reflects investor optimism regarding the restructuring plan's ability to stabilize the company's financial profile and growth trajectory.
Year to date, Sarepta's shares have plunged 85% compared with the industry's 2% decline.
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Sarepta to Update Elevidys Label With Black Box Warning
Investor sentiment toward the stock has worsened significantly after two patient deaths were linked to Elevidys, both caused by acute liver failure (ALF) in non-ambulatory DMD patients. While Sarepta has already suspended both clinical and commercial Elevidys dosing for non-ambulatory patients, the therapy has been mandated by the FDA to carry a black box warning for ALF and acute liver injury.
To address this safety issue, Sarepta is working to create a new protocol with an enhanced immunosuppression regimen to make Elevidys administration safer for non-ambulatory DMD patients. The company plans to submit these findings to the FDA in hopes of resuming dosing in the non-ambulation population.
Sarepta developed Elevidys in partnership with pharma giant Roche RHHBY. In 2019, SRPT and Roche entered into a licensing agreement to develop Elevidys. Per the agreement, Roche has exclusive rights to launch and market the therapy in non-U.S. markets.
Sarepta Provides Q2 Preliminary Numbers
Alongside the restructuring plan, Sarepta also issued preliminary/unaudited figures for the second quarter of 2025. The company reported total net product revenues of $513 million, which beat both the Zacks Consensus Estimate of $506 million and our model estimate of $507 million.
The unaudited revenue numbers include $282 million from Elevidys. The Zacks Consensus Estimate and our model estimate for Elevidys' sales are pegged at $274 million and $280 million, respectively.
Sarepta also reported preliminary combined adjusted R&D and SG&A expenses of around $294 million for the quarter. As of the end of June 2025, unaudited cash and short-term investments totaled approximately $850 million.
The company plans to report full second-quarter results early next month.
Sarepta Therapeutics, Inc. Price
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SRPT's Zacks Rank
Sarepta currently carries a Zacks Rank #4 (Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
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Partner Roche will continue its dialogue with the European Medicines Agency to explore a potential path forward to make ELEVIDYS available to individuals living with Duchenne muscular dystrophy in the EU ELEVIDYS is the first and only disease-modifying gene therapy for Duchenne CAMBRIDGE, Mass., July 25, 2025--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the conditional marketing authorization (CMA) for ELEVIDYS (delandistrogene moxeparvovec) in ambulatory individuals ages three to seven years for the treatment of Duchenne muscular dystrophy (DMD). "While we are disappointed by the CHMP's negative opinion, we understand the urgent need for continued dialogue and collaboration to bring transformative therapies to people with Duchenne who live with a relentless disease that steals their mobility, independence and ultimately life – often by early adulthood," said Louise Rodino-Klapac, Ph.D., president of research & development and technical operations, Sarepta. "Following the initial FDA approval of ELEVIDYS on June 22, 2023, the therapy has subsequently received regulatory approval in several other countries. In the U.S., we are actively working with the FDA to address recent safety questions. We remain committed to working with regulators to address outstanding questions on safety so that people living with Duchenne have access to this important therapy." ELEVIDYS is the first and only approved gene therapy targeting the underlying cause of disease that has consistently demonstrated stabilization or slowing of DMD disease progression, with durable effects on functional and biological outcomes and muscle health. While the primary endpoint was not met in EMBARK after one year, ELEVIDYS showed clinically meaningful and statistically significant improvements across important secondary endpoints of functional outcome measures when compared to placebo. Longer term efficacy data were also submitted to EMA, including two-year results from the EMBARK study and three-year pooled efficacy analysis from three other ELEVIDYS studies that showed clinically meaningful improvements across key measures of motor function. One-year data from part one of the EMBARK study were published in Nature Medicine in October 2024, and results from year two were shared at this year's Muscular Dystrophy Association Clinical & Scientific Conference in Dallas. Quantitative muscle MR (magnetic resonance) outcomes from part 1 of EMBARK were published in JAMA Neurology in May 2025. Sarepta is responsible for regulatory approval and commercialization of ELEVIDYS in the U.S., as well as manufacturing. Roche is responsible for regulatory approvals and bringing ELEVIDYS to patients across the rest of the world. Regulatory approval and commercialization of ELEVIDYS in Japan is through Chugai Pharmaceuticals via its alliance with Roche. About ELEVIDYS (delandistrogene moxeparvovec-rokl)ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated in U.S. for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval in the U.S. based on expression of ELEVIDYS micro-dystrophin (noted hereafter as "micro-dystrophin") in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta TherapeuticsSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of InformationWe routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking StatementsThis statement contains "forward-looking statements." Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "will," "may," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, discussions with regulators and the prospects for approvals or continued approvals, as applicable, of ELEVIDYS and the potential benefits and risks of ELEVIDYS. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences; the possible impact of regulatory decisions by, and any halts imposed by, regulatory agencies on our business; and those risks identified under the heading "Risk Factors" in our most recent Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Source: Sarepta Therapeutics, Inc. View source version on Contacts Investor Contact: Ian Estepan617-274-4052iestepan@ Media Contacts: Tracy Sorrentino617-301-8566tsorrentino@ Kara Hoeger617-710-3898KHoeger@
