New York, Jan 24, 2026, 05:28 (EST) — Market closed.
- Sarepta dipped 3% on Friday before climbing roughly 5% in after-hours trading.
- The company will unveil 3-year “topline” functional data from the Phase 3 EMBARK study of Elevidys on Jan. 26.
- After recent label tightening, traders are focused on durability and safety details.
Sarepta Therapeutics Inc shares climbed in after-hours trading Friday following the announcement of a Jan. 26 update on three-year data for its Duchenne gene therapy, Elevidys. The stock had closed down 3% at $21.13 but later traded near $22.20, a roughly 5% gain. (MarketWatch)
The timing couldn’t be more critical. Sarepta is working to restore confidence in Elevidys after the FDA slapped on its strongest safety warning and restricted the drug’s use to patients who can still walk. This label change followed reports of deaths from acute liver failure in non-ambulatory patients. A spokesperson for Parent Project Muscular Dystrophy weighed in, saying, “Serious questions remain about the safety and long-term outcomes of these therapies.” (Reuters)
That’s the reason Monday is so important. The three-year mark is when gene therapies face the real test: whether early gains hold up and if any fresh safety issues emerge once the initial buzz fades.
Sarepta plans to hold a webcast and conference call at 8:30 a.m. Eastern on Monday to share three-year topline functional results — essentially the initial main outcome data — from Part 1 of EMBARK. The EMBARK trial is a global, randomized, placebo-controlled Phase 3 study, designed to support regulatory decisions. It involves ambulatory boys aged four to seven at the start of treatment. (Business Wire)
According to ClinicalTrials.gov, EMBARK is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety and effectiveness of gene transfer therapy in boys suffering from Duchenne muscular dystrophy, a genetic disorder that progressively deteriorates muscle strength. This trial design offers investors a clearer benchmark compared to open-label studies, though it also sets a tougher standard. (Clinicaltrials)
Elevidys (delandistrogene moxeparvovec-rokl) is a gene therapy based on an adeno-associated virus, or AAV, vector. According to the FDA’s product page, it’s approved in the U.S. for Duchenne patients aged four and up who are still ambulatory and carry a confirmed mutation in the DMD gene. Simply put, it’s meant for those who can still walk. (U.S. Food and Drug Administration)
The downside risk remains. The FDA is probing two deaths linked to acute liver failure in non-ambulatory Duchenne patients treated with Elevidys. Sarepta has paused shipments to this group and is collaborating with regulators on monitoring and updating labeling. (Reuters)
Investors have zeroed in on the cash angle. Earlier this month, Sarepta disclosed preliminary net product revenue for 2025 at $1.86 billion, with $898.7 million coming from Elevidys. The company attributed a sharp flu outbreak late in the year for pushing some infusions into 2026. CEO Doug Ingram noted that Elevidys’s Q4 revenue took a hit due to “the need in December to reschedule” patient infusions. (Business Wire)
The broader gene-therapy landscape remains uncertain. Pfizer announced in 2024 that its experimental Duchenne gene therapy failed to hit the primary endpoint in a late-stage trial, underscoring that producing a shortened dystrophin protein doesn’t always lead to noticeable improvements in motor function tests. (Reuters)
Monday’s U.S. session kicks off with a key timing factor: the 8:30 a.m. update arrives an hour before the open, meaning the stock could gap sharply if chatter heats up on social media beforehand. Traders will zero in on how quickly functional changes show up and any safety concerns raised, since one-time therapies leave little room for error. (Stock Titan)
Besides the Jan. 26 webcast, Sarepta plans to release final fourth-quarter and full-year 2025 results in late February, offering a clearer view of Elevidys demand trends. The next major trigger comes Monday morning. (Sarepta)
