Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
However, the use of the gene therapy remains on hold for Duchenne Muscular Dystrophy patients who cannot walk, the FDA said, adding that it is continuing to work with the company while investigating the death of two patients.
The FDA's recommendation for ambulatory patients — those who can walk — followed a probe that showed the death of an eight-year-old boy in Brazil, was unrelated to the gene therapy, the agency said.
Roche, which has partnered with Sarepta for commercialization outside the U.S., had previously said the patient's death was not related to the therapy, according to the reporting physician's assessment.
Sarepta is also facing intense scrutiny following the death of two non-ambulatory teenage boys associated with Elevidys, as well as a 51-year-old man who had received its experimental gene therapy SRP-9004.
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About Synaptigen Synaptigen is a natural daily-use brain support formula designed to promote cognitive clarity, memory retention, and sustained mental energy without relying on stimulants or synthetic nootropics. Developed with a science-forward mindset, the formula blends probiotics, prebiotics, and antioxidant-rich botanicals that support the gut-brain connection—an increasingly researched area in modern nutritional neuroscience. Rather than positioning itself as a cure or quick-fix, Synaptigen is built for long-term use. Its ingredients have been individually studied for their roles in promoting healthy glucose metabolism, reducing neuron-damaging sugar buildup, and supporting microbiome balance. Each capsule is manufactured in a GMP-certified facility, non-GMO, and free from additives commonly flagged by health-conscious users. The product also comes bundled with digital health content designed to complement the supplement's function—including sleep optimization guides and cognitive focus techniques—at no additional charge with qualifying orders. Learn More About Synaptigen's Mission and Formula Design Contact Synaptigen – Daily Brain Support Backed by Microbiome Research – Daily Brain Support Backed by Microbiome Research Email : [email protected] : [email protected] Phone (US) : 1-800-390-6035 : 1-800-390-6035 INT : +1 208-345-4245 : +1 208-345-4245 Website: This press release is for informational purposes only. The information contained herein does not constitute medical advice, diagnosis, or treatment and has not been evaluated by the Food and Drug Administration (FDA). Synaptigen is not intended to diagnose, treat, cure, or prevent any disease. Always consult your physician or qualified healthcare provider before beginning any new supplement, routine, or health program. Some links in this release may be promotional in nature and may lead to third-party websites. The publisher or author may receive compensation through affiliate commissions if a purchase is made through these links. This compensation does not affect the price you pay and helps support continued research and content publication. Results described or implied may not be typical and should not be interpreted as guarantees. Statements made about ingredients or outcomes reflect public discussion and historical usage only, and are not endorsed by medical professionals or regulatory agencies. Always do your own research and make informed decisions. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
