## Capricor's Deramiocel Shows Cardiovascular Promise in Pivotal DMD Trial, Fueling Market Confidence

Capricor Therapeutics Inc. (CAPR) delivered encouraging news to investors on Wednesday with the announcement of positive results from its Phase 3 HOPE-3 trial for Deramiocel, a candidate therapy addressing Duchenne muscular dystrophy. The market responded immediately, with the stock climbing over 14% during pre-market trading, reflecting investor enthusiasm for the clinical milestone.

The trial's success centers on Deramiocel's dual benefit profile. Over the 12-month study period, the therapy demonstrated both skeletal and cardiac improvements that reached statistical significance while maintaining meaningful clinical relevance. This achievement is particularly noteworthy because Duchenne cardiomyopathy represents the primary driver of mortality in DMD patients—a critical unmet medical need in the rare disease space.

**Clinical Significance and Treatment Landscape**

What makes this result particularly compelling is Deramiocel's potential positioning as a first-in-class therapeutic approach targeting the cardiac complications of DMD. Rather than addressing only muscle degeneration, this candidate uniquely tackles the heart-related aspects of the disease, which often prove fatal. The favorable safety and tolerability data from HOPE-3 aligns with findings from earlier clinical experiences, suggesting the therapy maintains a consistent risk-benefit profile across study populations.

**Regulatory Path Forward**

The regulatory trajectory now focuses on FDA engagement. Capricor received a Complete Response Letter for Deramiocel's Biologics License Application in July, signaling that additional data was required before approval consideration. The company has previously aligned with the FDA on its response strategy and now plans to incorporate the HOPE-3 findings into a resubmission package. This approach leverages the recent positive data to address previous regulatory concerns.

Prior to this announcement, Capricor's shares had closed at $6.36, down 4.36% on Tuesday, making Wednesday's gain a notable reversal of momentum for the biotech company pursuing this innovative DMD therapeutic.