CAPR Stock Skyrockets 282% in a Week: Here's What You Need to Know

Core Insights - Capricor Therapeutics (CAPR) shares surged 281.9% this week following positive results from a late-stage study of deramiocel for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][6] - Deramiocel is the company's lead product candidate and the only asset in its clinical pipeline, representing an investigational, allogeneic cardiac-derived cell therapy [1] Study Details - The phase III HOPE-3 study involved 106 boys and young men with DMD, averaging 15 years old, who received either intravenous deramiocel at 150 million cells per infusion or placebo every three months for a year while on stable corticosteroid therapy [2] - The study demonstrated a 54% slowing of disease progression in upper-limb function compared to placebo, indicating significant preservation of daily functional abilities [3] - The study also achieved a 91% slowing in the deterioration of left-ventricular ejection fraction, addressing a major unmet need in DMD patients [4] Market Performance - Over the past year, Capricor Therapeutics shares have increased by 71%, contrasting with a 0.8% decline in the industry [5] Regulatory Context - In July 2025, Capricor faced a regulatory setback when the FDA issued a complete response letter (CRL) regarding the biologics license application (BLA) for deramiocel, citing insufficient clinical evidence [9][10] - The company believes the new phase III HOPE-3 results strengthen deramiocel's clinical profile and plans to submit a formal response to the FDA, which had indicated that positive findings could support resubmission [11][12] Disease Context - DMD is a severe genetic disorder affecting approximately 15,000 individuals in the U.S., primarily boys, leading to progressive muscle loss and often resulting in cardiomyopathy and heart failure [13]