Investing.com – Sarepta Therapeutics Inc (NASDAQ:SRPT) stock rose 4.9% on Tuesday after Chugai Pharmaceutical Co., Ltd. officially launched ELEVIDYS gene therapy in Japan, which has been included in the Japanese National Health Insurance price list.
According to the collaboration agreement between Sarepta and Roche, this initial commercial sale in Japan will bring a $40 million milestone payment to Sarepta.
ELEVIDYS is Japan’s first approved gene therapy for the treatment of Duchenne Muscular Dystrophy. It is suitable for patients aged 3 to under 8 who can walk, with deletions of all or part of exons 8 and/or 9 in the DMD gene, and who test negative for anti-AAVrh74 antibodies.
The launch follows a conditional and time-limited approval granted by Japan’s Ministry of Health, Labour and Welfare in May 2025. As part of the Roche Group collaboration, Chugai Pharmaceutical will conduct post-marketing clinical studies and monitoring in Japan to evaluate long-term efficacy and safety.
Japan’s approval was based on clinical efficacy and safety data from the ELEVIDYS development program, including results from the global Phase 3 EMBARK study. The EMBARK study evaluated ambulatory boys with Duchenne Muscular Dystrophy and showed clinically meaningful improvements in key motor function measures with ELEVIDYS.
To date, over 1,200 patients worldwide have received ELEVIDYS treatment in clinical and real-world settings. The two-year results of the EMBARK study were published in Neurology & Therapy in January, with three-year results to be presented at an upcoming medical conference.
Under the collaboration agreement signed by Sarepta and Roche in 2019, Sarepta is responsible for regulatory approval, commercialization, and manufacturing of ELEVIDYS in the United States. Roche handles regulatory approval and commercialization outside the U.S., with commercialization in Japan carried out by Chugai Pharmaceutical, a Roche Group member.
This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.
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Sarepta Therapeutics stock price increases due to the launch of ELEVIDYS in Japan
Investing.com – Sarepta Therapeutics Inc (NASDAQ:SRPT) stock rose 4.9% on Tuesday after Chugai Pharmaceutical Co., Ltd. officially launched ELEVIDYS gene therapy in Japan, which has been included in the Japanese National Health Insurance price list.
According to the collaboration agreement between Sarepta and Roche, this initial commercial sale in Japan will bring a $40 million milestone payment to Sarepta.
ELEVIDYS is Japan’s first approved gene therapy for the treatment of Duchenne Muscular Dystrophy. It is suitable for patients aged 3 to under 8 who can walk, with deletions of all or part of exons 8 and/or 9 in the DMD gene, and who test negative for anti-AAVrh74 antibodies.
The launch follows a conditional and time-limited approval granted by Japan’s Ministry of Health, Labour and Welfare in May 2025. As part of the Roche Group collaboration, Chugai Pharmaceutical will conduct post-marketing clinical studies and monitoring in Japan to evaluate long-term efficacy and safety.
Japan’s approval was based on clinical efficacy and safety data from the ELEVIDYS development program, including results from the global Phase 3 EMBARK study. The EMBARK study evaluated ambulatory boys with Duchenne Muscular Dystrophy and showed clinically meaningful improvements in key motor function measures with ELEVIDYS.
To date, over 1,200 patients worldwide have received ELEVIDYS treatment in clinical and real-world settings. The two-year results of the EMBARK study were published in Neurology & Therapy in January, with three-year results to be presented at an upcoming medical conference.
Under the collaboration agreement signed by Sarepta and Roche in 2019, Sarepta is responsible for regulatory approval, commercialization, and manufacturing of ELEVIDYS in the United States. Roche handles regulatory approval and commercialization outside the U.S., with commercialization in Japan carried out by Chugai Pharmaceutical, a Roche Group member.
This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.