Deramiocel trial, FDA pivot, and ongoing lawsuit

Claims

What the coverage asserts, and how many sources carry each claim.

• [● 5 SOURCES] Capricor shares fell nearly 60% in pre‑market trading and more than 66% since FDA staff concerns were published.
• [● 4 SOURCES] FDA staff raised concerns that Capricor had not provided sufficient evidence of effectiveness and had changed key analyses after the late‑stage study.
• [● 4 SOURCES] The FDA is expected to issue a final decision on deramiocel by August 22.
• [● 4 SOURCES] The HOPE‑3 phase III trial enrolled 106 male participants aged 10‑22, with 54 receiving deramiocel and 52 receiving placebo.
• [● 4 SOURCES] Deramiocel participants lost arm function about 54 % more slowly than placebo participants.
• [● 4 SOURCES] The FDA advisory committee voted 9‑to‑3 against recommending approval of Capricor Therapeutics’ deramiocel therapy for Duchenne‑related cardiomyopathy.
• [● 3 SOURCES] In participants with existing cardiomyopathy, deramiocel preserved heart function better than placebo, with up to a 91 % slower progression of cardiac decline.
• [● 2 SOURCES] Allergic‑type reactions occurred in 42 % of deramiocel recipients versus 15 % of placebo; no deaths were reported.
• [● 2 SOURCES] In participants with cardiomyopathy, deramiocel showed a nominally significant benefit in left‑ventricular ejection fraction.

Timeline

1. 16 days ago

   [BUSINESS] 2 sources

   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. about 1 month ago

   [BUSINESS] 3 sources

   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. about 1 month ago

   [BUSINESS] 2 sources

   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​

4. about 2 months ago

   [HEALTH] 14 sources

   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

5. about 2 months ago

   [HEALTH] 2 sources

   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,

Sources

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