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Sarepta Therapeutics Inc :SAREPTA THERAPEUTICS ANNOUNCES APPROVAL OF CLINICAL TRIAL APPLICATION FOR SRP-1005, ITS INVESTIGATIONAL TREATMENT FOR HUNTINGTON’S DISEASESAREPTA THERAPEUTICS INC - FIRST-IN-HUMAN CLINICAL STUDY OF SRP-1005, KNOWN AS INSIGHTT, IS EXPECTED TO BEGIN IN Q2 OF 2026SAREPTA THERAPEUTICS INC: FIRST-IN-HUMAN CLINICAL STUDY OF SRP-1005, KNOWN AS INSIGHTT, IS EXPECTED TO BEGIN IN Q2 OF 2026

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Sarepta Therap

Sarepta Therapeutics Announces Clinical Trial Application Approval For SRP-1005 In Huntington’s Disease

Sarepta Therapeutics (NASDAQ:SRPT) announced three-year results from its EMBARK Phase 3 trial for ELEVIDYS, a gene therapy for Duchenne muscular dystrophy (DMD). The data showed significant disease-modifying effects, with treated patients demonstrating a 4.39-point improvement in NSAA and a 6-second advantage in time to arise compared to external controls. No new safety concerns were reported. Analysts remain optimistic, projecting a 179% upside despite challenges ahead for the company.

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Sarepta Therapeutics Touts 3-Year EMBARK Data Showing ELEVIDYS Slows DMD Decline, No New Safety Flags

Health care stocks saw gains late Monday, with the NYSE Health Care Index and the State Street Health Care Select Sector SPDR ETF rising 0.5%. Biogen's shares increased 1% following FDA review news for Leqembi. Sarepta Therapeutics surged 7.2% on positive trial results for Elevidys, while Cogent Biosciences rose 3.2% after receiving breakthrough therapy designation. Conversely, Merck's shares fell 0.7% after dropping its bid for Revolution Medicines, which plummeted nearly 17%.

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Sector Update: Health Care Stocks Advance Late Afternoon

U.S. stocks rose on Monday, with the Dow Jones gaining over 100 points. Sarepta Therapeutics shares surged 9.8% after positive results from its Phase 3 study of Elevidys for Duchenne muscular dystrophy. Lands' End jumped 38.8% following a joint venture announcement. Other notable gainers included Alpha Technology Group (+26.8%), Rich Sparkle Holdings (+22%), and TRX Gold (+18%). Precious metals stocks rose amid safe-haven demand due to geopolitical concerns. USA Rare Earth climbed 14.3% after a funding announcement with the U.S. government. CoreWeave gained 9.5% after expanding its collaboration with Nvidia.

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Sarepta Therapeutics, Lands' End, USA Rare Earth, CoreWeave And Other Big Stocks Moving Higher On Monday

Sarepta Therapeutics Inc. announced positive three-year results from its Phase 3 EMBARK study of Elevidys for Duchenne muscular dystrophy. Patients treated with Elevidys showed significant improvements in motor function, with a 73% slowing of disease progression compared to a control group. The drug is the only approved gene therapy for Duchenne and has been administered to over 1,200 patients. Sarepta reported fourth-quarter product revenue of $369.6 million and full-year revenue of $1.86 billion for 2025. Shares rose 5.06% to $22.20 in premarket trading.

Sarepta Says Elevidys Slows Duchenne Progression After Three Years

Sarepta Therapeutics shares are trading higher after the company announced topline three-year functional results from Part 1-treated patients in EMBARK study.

Sarepta Therapeutics' gene therapy, Elevidys, has shown sustained benefits in slowing disease progression in patients with Duchenne muscular dystrophy, according to three-year data from a late-stage study. The therapy improved patients' ability to perform physical activities and demonstrated a 73% reduction in disease progression compared to untreated controls. Despite previous safety concerns, the positive long-term results may help restore confidence in Elevidys, which is crucial for the company's sales amid scrutiny over its effectiveness.

Sarepta's Duchenne gene therapy slows disease progression, three-year data shows

Genethon, a non-profit gene therapy R&D organization, is advancing gene therapies for rare genetic diseases, including Duchenne muscular dystrophy (DMD) and Pompe disease. The organization has entered a licensing deal with AskBio for a proprietary technology and is conducting pivotal clinical trials for its micro-dystrophin gene therapy (GNT0004) for DMD. CEO Frederic Revah highlights the dedication of Genethon's 240 scientists in developing innovative treatments. The latest newsletter also features updates on clinical trials and research discoveries related to gene therapy for DMD.

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Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases

Sarepta Therapeuticsshares rose 6.4% to $22.49 in premarket trading. The company announced it will present three-year results from its EMBARK trial of Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), on January 26 at 8:30 a.m. ET. The trial tested Elevidys against a placebo in boys aged 4 to 7 who had not lost the ability to walk due to DMD. Shares previously fell approximately 82% in 2025.

BUZZ-Sarepta to release 3-year data for muscle dystrophy gene therapy; shares rise

U.S. stock futures fell as major indices declined ahead of earnings reports from companies like UnitedHealth and Microsoft. The Dow Jones dropped 0.12%, S&P 500 down 0.24%, Nasdaq 100 down 0.44%, and Russell 2000 down 0.29%. The 10-year Treasury bond yield is at 4.21%. Notable stocks include Baker Hughes up 3.74% and Sarepta Therapeutics up 6.72%. The Fed is expected to keep interest rates steady, with a 97.2% likelihood of no change in January.

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U.S. stock futures fell as investors prepare for mega-cap earnings. Market indices down, with 10-year Treasury bond at 4.21%. Notable stocks include BKR up 3.74% and SRPT up 6.72%. Fed likely to keep interest rates steady. Dow Jones -0.12%, S&P 500 -0.24%, Nasdaq 100 -0.44%, Russell 2000 -0.29%. SPY down 0.22% to $687.69, QQQ declined 0.43% to $620.04.

Sarepta Therapeutics Inc. will present three-year topline results from the EMBARK Phase 3 study of ELEVIDYS in Duchenne muscular dystrophy on January 26, 2026. The presentation will be available via a webcast and conference call on the company's investor relations website, with a replay accessible for one year.

Sarepta Therapeutics to Present 3-Year Topline Results from EMBARK Phase 3 Study of ELEVIDYS in Duchenne Muscular Dystrophy

Biotech stocks experienced significant movements in after-hours trading, led by Sarepta Therapeutics (SRPT), which surged 9.65% to $23.17 ahead of key trial data. Other notable gainers included Fractyl Health (GUTS) up 7.66%, Greenwich LifeSciences (GLSI) rising 2.08% after FDA approval of GP2 vials, and Anebulo Pharmaceuticals (ANEB) increasing 8.41%. Trevi Therapeutics (TRVI) gained 3.40% following positive trial results published in JAMA. AEON Biopharma (AEON) edged up 1.80% after securing FDA meeting and shareholder approval for financing transactions.

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After-Hours Gainers: Biotech Stocks In Focus

Sarepta jumps on upcoming release of 3-year Elevidys data

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Sarepta jumps on upcoming release of 3-year Elevidys data

Sarepta Therapeutics Inc :SAREPTA THERAPEUTICS TO REPORT 3-YEAR TOPLINE DATA FROM EMBARK STUDY OF ELEVIDYS GENE THERAPY IN AMBULATORY INDIVIDUALS WITH DUCHENNE MUSCULAR DYSTROPHY

Sarepta Therapeutics To Report 3-Year Topline Data From Embark Study Of Elevidys Gene Therapy

Sarepta Therapeutics shares are trading higher. The company announced that it will present 3-year topline functional results from patients treated in Part 1 of EMBARK, Phase 3 study of ELEVIDYS in ambulatory individuals with Duchenne muscular dystrophy on January 26.

Tradr 2X Long SRPT Daily ETF(SRPU.US)

Sarepta Therapeutics Announces Clinical Trial Application Approval For SRP-1005 In Huntington’s Disease

Sarepta Therapeutics Touts 3-Year EMBARK Data Showing ELEVIDYS Slows DMD Decline, No New Safety Flags

Sector Update: Health Care Stocks Advance Late Afternoon

Sarepta Therapeutics, Lands' End, USA Rare Earth, CoreWeave And Other Big Stocks Moving Higher On Monday

Sarepta Says Elevidys Slows Duchenne Progression After Three Years