Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced the commercial launch of ELEVIDYS (delandistrogene moxeparvovec) in Japan by Chugai Pharmaceutical Co., Ltd., following its reimbursement listing on Japan’s National Health Insurance (NHI) price list.

Elevidys is the first gene therapy to be launched in Japan for Duchenne muscular dystrophy (DMD). In Japan, ELEVIDYS is available for ambulatory individuals with Duchenne ages 3-to less than 8-years-old, a deletion of any portion or the entirety of exon 8 and/or exon 9 in the DMD gene, and who are negative for anti-AAVrh74 antibodies.

“The commercial launch of ELEVIDYS in Japan marks an important step in expanding access to this therapy, where early intervention may offer the greatest opportunity to preserve muscle function,” said Louise Rodino-Klapac‑, Ph.D., president of research & development and technical operations, Sarepta. “We are delighted that ELEVIDYS is now available to eligible patients in Japan and remain focused on advancing rigorous science and generating long-term clinical and real-world evidence to help inform care for the Duchenne community worldwide.”

Chugai announced that ELEVIDYS has been launched in Japan following reimbursement listing, enabling access for eligible patients under the conditional and time limited approval granted by Japan’s Ministry of Health, Labour and Welfare (MHLW) in May 2025. Chugai will be responsible for postmarketing clinical studies and all case postmarketing surveillance in Japan as part of the Roche Group collaboration to further evaluate long-term efficacy and safety.

The approval in Japan was based on efficacy and safety data from the ELEVIDYS clinical development program, including results from the global Phase 3 EMBARK study. EMBARK evaluated ELEVIDYS in ambulatory boys with DMD and demonstrated clinically meaningful improvements in key motor function measures. Longer term follow-up data have shown sustained functional efficacy over time and slower disease progression compared to external control, with no new treatment-related safety signals observed in ambulatory patients. Two-year EMBARK results were published in Neurology & Therapy in January, and three-year results will be shared at an upcoming medical congress. To date, ELEVIDYS has been administered to over 1,200 patients globally in clinical and real-world settings.

As part of a collaboration agreement signed in 2019, Sarepta is working with Roche to transform the future for the Duchenne community, with the goal of enabling those living with the disease to maintain and protect their muscle function. Sarepta is responsible for regulatory approval and commercialization of ELEVIDYS in the U.S., as well as manufacturing. Roche is responsible for regulatory approvals and commercialization in territories outside the U.S. Commercialization of ELEVIDYS in Japan is through Chugai Pharmaceuticals, a member of the Roche Group.

Under Sarepta’s collaboration agreement with Roche, the first commercial sale of ELEVIDYS in Japan will trigger a $40 million milestone payment to Sarepta.