# Deramiocel trial, FDA pivot, and ongoing lawsuit > Live situation record from CLSTR: https://clstr.news/situations/deramiocel-dmd-trial-fda-decision > Updated: 2026-08-28T16:00:38.000Z. Sources: 21. Developments: 5. Capricor Therapeutics is navigating a shifting regulatory and strategic landscape following an FDA advisory committee vote against the original effectiveness case for deramiocel in treating Duchenne cardiomyopathy. In response, the company has narrowed its Biologics License Application to focus on upper limb skeletal muscle function, supported by the HOPE-3 trial meeting its primary endpoint for that specific metric. This regulatory pivot has resulted in the FDA extending the review decision deadline to November 22, 2026. Financially, Capricor reported $237.9 million in cash, cash equivalents, and marketable securities as of June 30, 2026, while recording a net loss of $74.7 million for the first half of the year. Despite recent stock pullbacks, Oppenheimer recently upgraded the company to ‘Outperform,’ suggesting potential upside. Simultaneously, the company continues to face legal challenges via the federal securities class-action lawsuit, Nkamga v. Capricor Therapeutics, Inc. The suit, representing investors who purchased securities between December 2025 and July 2026, alleges that Capricor made misleading statements or omissions regarding the HOPE-3 trial’s statistical analysis plan and the likelihood of FDA approval. ## Claims - Capricor shares fell nearly 60% in pre‑market trading and more than 66% since FDA staff concerns were published. (corroborated by 5 sources) - FDA staff raised concerns that Capricor had not provided sufficient evidence of effectiveness and had changed key analyses after the late‑stage study. (corroborated by 4 sources) - The FDA is expected to issue a final decision on deramiocel by August 22. (corroborated by 4 sources) - The HOPE‑3 phase III trial enrolled 106 male participants aged 10‑22, with 54 receiving deramiocel and 52 receiving placebo. (corroborated by 4 sources) - Deramiocel participants lost arm function about 54 % more slowly than placebo participants. (corroborated by 4 sources) - The FDA advisory committee voted 9‑to‑3 against recommending approval of Capricor Therapeutics’ deramiocel therapy for Duchenne‑related cardiomyopathy. (corroborated by 4 sources) - In participants with existing cardiomyopathy, deramiocel preserved heart function better than placebo, with up to a 91 % slower progression of cardiac decline. (corroborated by 3 sources) - Allergic‑type reactions occurred in 42 % of deramiocel recipients versus 15 % of placebo; no deaths were reported. (corroborated by 2 sources) - In participants with cardiomyopathy, deramiocel showed a nominally significant benefit in left‑ventricular ejection fraction. (corroborated by 2 sources) ## Timeline ### 2026-08-28: Capricor Therapeutics pivots regulatory strategy amid legal challenges Capricor Therapeutics is pivoting its FDA application to focus on upper limb function after a rejected cardiomyopathy case, while facing a securities class action lawsuit. 2 sources. https://clstr.news/cluster/capricor-therapeutics-pivots-regulatory-strategy-amid-legal-challenges ### 2026-08-13: Capricor Therapeutics faces FDA regulatory shifts and securities lawsuit Capricor Therapeutics is seeking to refine its FDA application for deramiocel to focus on upper limb function following an advisory committee vote, while facing a federal securities class action lawsuit. 3 sources. https://clstr.news/cluster/capricor-therapeutics-faces-fda-regulatory-shifts-and-securities-lawsuit ### 2026-08-01: Capricor Therapeutics hit by FDA panel vote and investor lawsuit over DMD therapy Capricor Therapeutics' Deramiocel therapy for Duchenne muscular dystrophy received a 9‑3 FDA advisory panel vote against effectiveness, sending its stock tumbling, while a securities class action alleges the f​ 2 sources. https://clstr.news/cluster/capricor-therapeutics-hit-by-fda-panel-vote-and-investor-lawsuit-over-dmd-therapy ### 2026-07-29: FDA panel rejects Capricor's deramiocel therapy for Duchenne heart disease FDA’s advisory committee voted 9‑3 against Capricor’s deramiocel for Duchenne cardiomyopathy, citing weak data; shares fell ~60%; phase III trial showed 54 % slower arm decline but limited cardiac benefit; FDA決 14 sources. https://clstr.news/cluster/deramiocel-cell-therapy-shows-slowed-muscle-decline-in-advanced-duchenne-dystrophy-trial ### 2026-07-27: Capricor Therapeutics’ Deramiocel Fails FDA Phase 3 Trial in Duchenne Muscular Dystrophy The FDA concluded Capricor Therapeutics’ Phase 3 trial of the stem‑cell therapy deramiocel missed primary and secondary endpoints for Duchenne muscular dystrophy, citing insufficient efficacy and safety issues, 2 sources. https://clstr.news/cluster/capricor-therapeutics-deramiocel-fails-fda-phase-3-trial-in-duchenne-muscular-dystrophy --- Cite as: Deramiocel trial, FDA pivot, and ongoing lawsuit. CLSTR, https://clstr.news/situations/deramiocel-dmd-trial-fda-decision