Business
Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy
Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively)Statistical significance was achieved in all type 1 error controlled secondary endpoints Results demonstrate clinically meaningful and statistically significant skeletal and cardiac benefits, supporting Deramiocel as a potential first-in-class therapy designed to treat
About this update from Capricor Therapeutics, Inc.
[{"type":"image","alt":"Capricor Therapeutics","displaySize":"","headline":null,"caption":"Capricor Therapeutics","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":107,"url":"https://media.zenfs.com/en/globenewswire.com/9425e1c34a8f71096412f48bc76eaba7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YaI1GjtfVRH2kLVsjMQa4A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/9425e1c34a8f71096412f48bc76eaba7","width":300,"height":107}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively)","length":231,"tagName":"p"}]},{"val":[{"type":"text","content":"Statistical significance was achieved in all type 1 error controlled secondary endpoints ","length":88,"tagName":"p"}]},{"val":[{"type":"text","content":"Results demonstrate clinically meaningful and statistically significant skeletal and cardiac benefits, supporting Deramiocel as a potential first-in-class therapy designed to treat Duchenne cardiomyopathy, the leading cause of mortality in Duchenne","length":248,"tagName":"p"}]},{"val":[{"type":"text","content":"Deramiocel maintained a favorable safety and tolerability profile consistent with prior clinical experience","length":107,"tagName":"p"}]},{"val":[{"type":"text","content":"Company plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA","length":130,"tagName":"p"}]},{"val":[{"type":"text","content":"Conference call and webcast today at 8:00 a.m. ET","length":49,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":853,"olType":false},{"type":"text","content":"SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD).","length":405,"tagName":"p"},{"type":"text","content":"“HOPE-3 delivered strong and definitiv...