TLDR
- CAPR surges 341% as HOPE-3 trial shows major gains in Duchenne treatment.
- Capricor’s Deramiocel impresses in Phase 3, stock explodes to record highs.
- CAPR hits $28 after DMD trial success; Deramiocel shows life-changing results.
- Capricor’s DMD breakthrough drives stock to soar over 300% in one day.
- HOPE-3 triumph fuels Capricor’s 341% stock leap on strong therapy results.
Capricor Therapeutics (CAPR) stock surged 341.04% to $28.05 after the release of pivotal HOPE-3 Phase 3 trial results.
Capricor Therapeutics, Inc., CAPR
The biotechnology company announced that its investigational cell therapy, Deramiocel, met primary endpoints in treating Duchenne muscular dystrophy (DMD). This sharp spike in CAPR stock followed a morning peak near $40, reflecting early and intense trading activity.
Deramiocel Achieves Primary Endpoint in HOPE-3 Trial
CAPR confirmed that Deramiocel significantly slowed disease progression in non-ambulatory DMD patients. The HOPE-3 trial showed a 54% reduction in skeletal muscle decline using the PUL v2.0 assessment tool. The therapy improved both skeletal and cardiac functions with consistent safety results.
The trial included 106 participants from 20 U.S. sites who received intravenous Deramiocel or placebo over 12 months. All patients remained on stable corticosteroid therapy, ensuring consistent background treatment across both arms. The results were statistically significant, strengthening confidence in Deramiocel’s clinical benefit.
CAPR emphasized the therapy’s impact on maintaining independence and quality of life for severely affected patients. Over 75% of participants had cardiomyopathy, and nearly 90% were on cardiac medications. These factors underscored the real-world relevance of the outcomes and Capricor’s focus on high-need populations.
HOPE-3 Validates Long-Term Potential of Deramiocel
The new findings align with earlier results from the HOPE-2 trial and its open-label extension. CAPR noted consistent benefits across all studies over the past decade of development. This consistency adds weight to their regulatory strategy for FDA approval.
Deramiocel preserved heart function by maintaining left ventricular ejection fraction in a condition where cardiomyopathy is the top cause of death. This advancement marked a potential shift in how Duchenne muscular dystrophy is managed long-term. Cardiologists highlighted the significance of cardiac stabilization, a key unmet need in DMD treatment.
CAPR now plans to engage with regulators using HOPE-3 data to address prior FDA concerns. The company believes the new evidence answers key questions raised in a recent Complete Response Letter. These trial outcomes reinforce Deramiocel’s promise as a transformative therapy.
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