Welcome to our dedicated page for Sarepta Therapeutics news (Ticker: SRPT), a resource for investors and traders seeking the latest updates and insights on Sarepta Therapeutics stock.
Sarepta Therapeutics, Inc. develops and commercializes precision genetic medicines for rare diseases, with a central focus on Duchenne muscular dystrophy and other neuromuscular conditions. Company news commonly covers product revenue and commercialization trends for ELEVIDYS and PMO therapies, including AMONDYS 45, VYONDYS 53 and EXONDYS 51.
Updates also address FDA interactions for Duchenne therapies, clinical and biomarker data from the siRNA pipeline, and programs such as SRP-1001 for FSHD1 and SRP-1003 for DM1. Other recurring announcements include quarterly financial results, Nasdaq inducement equity grants, and patient-community initiatives tied to Duchenne muscular dystrophy.
Sarepta (NASDAQ:SRPT) announced screening and enrollment are underway in ENDEAVOR Cohort 8 to test a prophylactic sirolimus-enhanced immunosuppression regimen alongside ELEVIDYS in non-ambulatory Duchenne patients. Approximately 25 participants will receive 14 days of peri-infusion sirolimus plus continued dosing for 12 weeks. Primary endpoints are incidence of acute liver injury (ALI) and ELEVIDYS-dystrophin expression at 12 weeks. ENDEAVOR has enrolled 55 participants across seven cohorts; ELEVIDYS has been administered to over 1,200 patients globally. The cohort aims to assess whether sirolimus mitigates ALI risk in older, non-ambulatory patients.
Sarepta Therapeutics (NASDAQ:SRPT) opened applications for Route 79, The Duchenne Scholarship Program for the 2026-2027 academic year. Scholarships of up to $5,000 will be awarded to up to 20 individuals with Duchenne and up to 5 siblings.
Applications are accepted through May 15, 2026; recipients will be notified before July 31, 2026 and awards distributed to schools for fall 2026 enrollment.
Sarepta Therapeutics (NASDAQ:SRPT) will present new long-term efficacy, safety and caregiver-reported data at the Muscular Dystrophy Association Clinical & Scientific Conference, March 8–11, 2026 in Orlando.
Key items include a late-breaking oral on delandistrogene moxeparvovec (EMBARK) functional outcomes up to 3 years versus a matched external control, a pooled safety analysis with up to 7.5 years follow-up, Phase 3 ESSENCE topline results for golodirsen and casimersen, caregiver impressions through 2 years, and multiple real-world and pharmacokinetic posters.
Sarepta Therapeutics (NASDAQ:SRPT) reported Q4 2025 and full‑year results on Feb 25, 2026: FY2025 revenue $2,198.2M (+16% YoY), Q4 revenue $442.9M, and net product revenue for FY2025 of $1,864.3M (PMO $965.6M; ELEVIDYS $898.7M). GAAP net loss for FY2025 was $713.4M (GAAP diluted loss per share $7.13). Cash, cash equivalents and investments were $953.8M at 12/31/2025. Corporate actions included refinancing 2027 notes into 2030 notes, ELEVIDYS launch in Japan (eligible $40M milestone), positive 3‑year EMBARK data, and advancing multiple siRNA programs with a Huntington’s CTA approved to start in Q2 2026.
Sarepta Therapeutics (NASDAQ:SRPT) announced the commercial launch of ELEVIDYS in Japan on February 24, 2026, via Chugai after National Health Insurance reimbursement and MHLW conditional, time-limited approval (May 2025).
ELEVIDYS is available for ambulatory Duchenne patients aged 3 to less than 8 years with deletions in exon 8 and/or exon 9 and negative anti-AAVrh74 status; the first Japan sale triggers a $40 million milestone payment to Sarepta.
Sarepta Therapeutics (NASDAQ:SRPT) said senior management will appear in a fireside chat at the TD Cowen 46th Annual Health Care Conference in Boston on March 3, 2026 at 1:50 p.m. ET. The presentation will be webcast live via the company's investor relations site and archived for 90 days.
Investors are advised to connect several minutes early to allow time for any required software downloads.
Sarepta Therapeutics (NASDAQ:SRPT) will report fourth-quarter and full-year 2025 financial results after the Nasdaq close on Wednesday, Feb. 25, 2026.
A conference call and live webcast will follow at 4:30 p.m. ET; a replay will be archived on the company's investor site for one year. Phone participants must register to receive dial-in details and a personal PIN.
Sarepta (NASDAQ:SRPT) announced Medsafe approval of the clinical trial application for SRP-1005, enabling the Phase 1 INSIGHTT study to begin. The first-in-human, multi-center, dose-escalation trial will enroll ~24 participants and is expected to start in Q2 2026.
SRP-1005 is an siRNA designed with a TfR1 monovalent fAb delivery approach for subcutaneous dosing to target deep brain regions in Huntington’s disease.
Sarepta (NASDAQ:SRPT) reported positive topline three-year results from Part 1 of EMBARK showing durable, statistically significant motor benefit for ELEVIDYS (delandistrogene moxeparvovec-rokl) in ambulatory Duchenne patients treated at ages 4–7 and followed to a mean age of ~9. At Year 3 (n=52 treated), mean NSAA remained above baseline (+4.39 LSM vs external control, p=0.0002), with TTR and 10MWR showing sustained improvement versus a propensity-weighted external control (TTR LSM difference -6.05s; 10MWR -2.70s, p=0.0039) and ~70% or greater slowing of decline on timed tests. No new treatment-related safety signals were observed; analysis and publications are ongoing.
Sarepta Therapeutics (NASDAQ:SRPT) will present 3-year topline functional results from Part 1 of EMBARK (Study 9001-301) on Jan. 26, 2026 at 8:30 AM ET. EMBARK is a global, randomized, placebo-controlled Phase 3 study evaluating ELEVIDYS (delandistrogene moxeparvovec-rokl) in ambulatory individuals with Duchenne muscular dystrophy who were aged four to seven at treatment.
The company will host a live webcast and conference call under its investor relations site and will archive a replay for one year. Phone participants must register online to receive dial-in details and a personal PIN via auto-generated email.