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Roche to Run New Elevidys Trial for European Approval; FDA Plans Advisory Panels on Compounded Peptides
Roche announced a new trial of Elevidys, Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, to pursue approval in Europe. Meanwhile, the FDA will hold advisory panel meetings starting July 2026 to reconsider restrictions on compounded peptides.
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Roche will conduct another clinical trial of Elevidys, a gene therapy for Duchenne muscular dystrophy developed by Sarepta Therapeutics, as part of its effort to obtain European regulatory approval, Stat reported. U.S. In related pharmaceutical developments, Eli Lilly announced that its GLP-1 pill Foundayo demonstrated non-inferiority compared with insulin glargine in a cardiovascular outcomes trial involving patients with diabetes and obesity.
U.S. Food and Drug Administration (FDA) as a treatment for type 2 diabetes by the end of the second quarter of 2026, utilizing the Commissioner’s National Priority Review Voucher. Separately, the FDA is revisiting its regulatory stance on compounded peptides, which it had previously moved to restrict.
The agency announced it will convene an external advisory panel to reconsider whether compounding pharmacies should be allowed to produce these peptides. The first advisory panel meetings are scheduled for July 2026, with a subsequent meeting planned before February 2027.
These developments reflect ongoing regulatory and clinical activity in gene therapies and diabetes treatments, as well as evolving FDA oversight of compounded pharmaceuticals.
