Capricor Therapeutics, Inc. Q3 2026 Earnings Recap

Capricorn Therapeutics shares rose 26.5% after the earnings call, as investors responded to the company’s account of positive HOPE-3 efficacy data and its view that the FDA review is nearing completion. The BLA remains under review, with the agency’s target action date extended to November 22.

Key Takeaways

• Capricorn said HOPE-3 met its primary endpoint: the 1-year difference on the Performance of the Upper Limb 2.0 was 1.1 points versus placebo (p=0.029), which management characterized as clinically meaningful.
• In the 24-month open-label extension, patients who switched from placebo to deramiocel saw their annual decline slow from about 2 points to about 0.5 points; the company described these results as supportive but noted they are descriptive.
• Cardiac results were mixed: deramiocel slowed progression of heart muscle scarring, while the overall ejection-fraction difference versus placebo was not statistically significant. In the prespecified subgroup with existing cardiomyopathy, ejection fraction improved by approximately 2.8 percentage points relative to placebo.
• The FDA is reviewing an August BLA amendment that included 24-month HOPE-3 data and additional analyses. Capricorn said all requested information has been submitted; the review is ongoing.
• Management said the proposed refined indication focuses on treatment of upper-limb impairment in patients older than 9 years.