TLDR

Sarepta Therapeutics will present 3-year data from the EMBARK Phase 3 study of Elevidys on January 26, 2026 at 8:30 am Eastern Time
The stock closed down 3% at $21.13 on Friday but jumped roughly 5% in after-hours trading to near $22.20 following the announcement
FDA recently added its strongest safety warning to Elevidys and restricted use to ambulatory patients after deaths from acute liver failure in non-ambulatory patients
Sarepta reported preliminary 2025 net product revenue of $1.86 billion, with Elevidys contributing $898.7 million despite Q4 challenges from flu season
The 3-year data release is critical for demonstrating whether early treatment gains hold up and addressing ongoing safety concerns

Sarepta Therapeutics shares moved higher in after-hours trading Friday after the company announced it will present 3-year data for its Duchenne gene therapy on Monday morning. The stock had closed down 3% at $21.13 but climbed to around $22.20 after hours, a roughly 5% gain.

Sarepta Therapeutics, Inc., SRPT

The company will host a webcast and conference call at 8:30 am Eastern Time on January 26 to share topline functional results from Part 1 of its EMBARK study. The timing comes one hour before market open, which could trigger sharp price movements if early reactions spread on social media.

EMBARK is a global, randomized, placebo-controlled Phase 3 trial of Elevidys in ambulatory boys with Duchenne muscular dystrophy aged four to seven at treatment start. The study design offers investors a clearer benchmark than open-label studies but also sets a tougher standard.

The data release arrives at a critical moment for Sarepta. The FDA recently slapped its strongest safety warning on Elevidys 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.

Safety Concerns Take Center Stage

The FDA is currently investigating two deaths linked to acute liver failure in non-ambulatory Duchenne patients treated with Elevidys. Sarepta has paused shipments to this patient group and is working with regulators on monitoring protocols and label updates.

A spokesperson for Parent Project Muscular Dystrophy stated that “serious questions remain about the safety and long-term outcomes of these therapies.” These concerns make Monday’s 3-year data particularly important for assessing durability and safety signals.

The three-year mark represents a key test for gene therapies. Investors want to see whether early treatment gains hold up over time and if new safety issues emerge once the initial treatment period ends.

Elevidys is a gene therapy based on an adeno-associated virus vector. According to the FDA’s product page, it’s approved for Duchenne patients aged four and up who are still ambulatory and carry a confirmed DMD gene mutation.

Revenue Performance Under Pressure

Earlier in January, Sarepta disclosed preliminary net product revenue for 2025 at $1.86 billion. Elevidys contributed $898.7 million to that total, though the fourth quarter proved challenging.

CEO Doug Ingram attributed weaker Q4 performance to a severe flu outbreak that forced the company to reschedule patient infusions. He noted that Elevidys Q4 revenue of $110.4 million took a hit due to “the need in December to reschedule” infusions into 2026.

Despite the recent turbulence, Sarepta’s stock has recovered 63.59% over the past six months. However, the year overall has presented challenges for the company.

The 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, showing that producing a shortened dystrophin protein doesn’t always translate to noticeable motor function improvements.

Traders will focus on how quickly functional changes appear in the 3-year data and whether any new safety concerns surface. One-time therapies leave little room for error, making durability data especially important.

A replay of Monday’s webcast will be archived on Sarepta’s investor relations website for one year. Participants joining by phone must register in advance to receive dial-in details.

Sarepta plans to release final fourth-quarter and full-year 2025 results in late February, which will provide a clearer view of Elevidys demand trends.

The post Sarepta Therapeutics (SRPT) Stock Jumps as Company to Present 3-Year Elevidys Data Monday appeared first on CoinCentral.

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Filed under: News - @ January 26, 2026 10:24 am