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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 Therapeutics (NASDAQ:SRPT) granted equity awards on Dec. 31, 2025 as material inducements to employment for 10 individuals hired in Q4 2025. The awards, approved under Sarepta’s 2024 Employment Commencement Incentive Plan and in accordance with Nasdaq Listing Rule 5635(c)(4), total 55,118 restricted stock units (RSUs) granted in the aggregate. The RSUs vest 25% annually on each anniversary of the grant date and will be fully vested on the fourth anniversary, subject to continued employment. No stock options were granted to these employees.
Sarepta Therapeutics (NASDAQ:SRPT) announced privately negotiated exchanges of approximately $291.4 million principal of its 1.25% convertible senior notes due 2027 for $291.4 million principal of new 4.875% convertible senior notes due 2030 plus $31.6 million in cash.
The Exchange is expected to close on or about December 18, 2025, subject to customary conditions. After closing, aggregate principal of the 4.875% notes due 2030 will be $893.4 million, and $158.6 million of the existing 2027 notes will remain outstanding.
Sarepta (NASDAQ:SRPT) said the FDA approved dosing for Cohort 8 of the ENDEAVOR study to test an enhanced immunosuppression regimen with sirolimus in ~25 non-ambulant Duchenne patients, with dosing expected to begin before year-end 2025. The regimen uses 14 days of peri-infusion sirolimus and continues for 12 weeks after ELEVIDYS infusion. Primary endpoints are incidence of acute liver injury (ALI) and ELEVIDYS-dystrophin expression at 12 weeks. Sarepta expects primary endpoint data collection in H2 2026 and will review results with the FDA to inform commercial dosing decisions for this population.
Sarepta (NASDAQ:SRPT) reported progress in the Phase 1/2 multiple ascending dose study of SRP-1003 for myotonic dystrophy type 1. Cohorts 1 (1.5 mg/kg) and 2 (3 mg/kg) are complete; cohort 3 (4.5 mg/kg) is fully enrolled and ongoing. Following a positive pre-specified drug safety committee review, the study will continue dose escalation with patients currently being dosed in cohort 4 (6 mg/kg) and planned initiation of cohort 5 (12 mg/kg) in early 2026. Having reached the enrollment target, a second milestone payment of $200 million to Arrowhead will be made within 60 days.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced it earned a $200 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT) after reaching the second development milestone in the Phase 1/2 study of ARO-DM1 (SRP-1003) for type 1 myotonic dystrophy.
The milestone followed a drug safety committee review, authorization to dose escalate, and attainment of a pre-specified patient enrollment target. Arrowhead said it expects to receive the payment within 60 days. The company reported cohort 4 (6 mg/kg) accrual is nearly complete and plans to begin enrollment in cohort 5 (12 mg/kg) in Q1 2026.
Sarepta (NASDAQ:SRPT) announced FDA approval of updated prescribing information for ELEVIDYS on November 14, 2025. Key label changes include a boxed warning for acute serious liver injury (ALI) and acute liver failure (ALF), removal of the non-ambulatory indication, expanded prescriber guidance with modified corticosteroid regimens, and enhanced weekly monitoring for 3 months post-infusion. The company plans to commence a study of an enhanced sirolimus immunosuppressive regimen to address ALI/ALF risk so dosing may resume for non-ambulatory patients with FDA concurrence. ELEVIDYS has been administered to over 1,100 patients globally.
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Sarepta Therapeutics (NASDAQ:SRPT) will report third quarter 2025 financial results after the Nasdaq Global Market closes on Monday, Nov. 3, 2025. A conference call to discuss results and recent corporate developments will follow at 4:30 p.m. ET.
The event will be webcast live via the investor relations site at https://investorrelations.sarepta.com/events-presentations and a replay will be archived there for one year. Phone participants must register online to receive dial-in details and a personal PIN by auto-generated email.
Sarepta Therapeutics (NASDAQ:SRPT) will present new clinical and real-world data at the 30th World Muscle Society Congress, Oct 7–11, 2025 in Vienna.
Presentations cover delandistrogene moxeparvovec (micro-dystrophin expression, safety, cardiac outcomes, mitigation of acute liver injury), a real-world pulmonary function study of casimersen, and EMERGENE phase 3 results for bidridistrogene xeboparvovec (SRP-9003) showing SGCB expression and safety in LGMD2E/R4. Multiple investigator-led delandistrogene abstracts (including sirolimus prophylaxis) will also be presented. Abstracts will be posted on Sarepta.com after the WMS embargo.
Sarepta Therapeutics (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, has announced equity inducement grants to 8 new employees hired in Q3 2025. The grants, approved under the company's 2024 Employment Commencement Incentive Plan, consist of 49,805 restricted stock units (RSUs). These RSUs will vest over four years, with 25% vesting annually on the grant date anniversary, contingent on continued employment.
The equity awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by the Compensation Committee of Sarepta's Board of Directors.