{"id":57688,"date":"2026-07-28T08:59:31","date_gmt":"2026-07-28T08:59:31","guid":{"rendered":"https:\/\/www.europesays.com\/news\/57688\/"},"modified":"2026-07-28T08:59:31","modified_gmt":"2026-07-28T08:59:31","slug":"fda-questions-the-efficacy-of-capricors-duchenne-drug","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/news\/57688\/","title":{"rendered":"FDA questions the efficacy of Capricor’s Duchenne drug"},"content":{"rendered":"

The Food and Drug Administration said Monday that Capricor Therapeutics\u2019 stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of a Phase 3 trial \u2014 contrary to the company\u2019s claims last year<\/a>.<\/p>\n

Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine.\u00a0<\/p>\n

The data were also notable for coming primarily in teenagers and young men who have already lost the ability to walk, a population with few options. The drug appeared to both preserve their upper-arm function and stave off the heart failure most patients eventually experience, Capricor had said.\u00a0<\/p>\n

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