CAPRICOR THERAPEUTICS, INC. 8-K

Summary

Capricor reported peer-reviewed final one-year HOPE-3 results and an update to the statistical model for Deramiocel’s LVEF endpoint. The FDA’s review of the BLA remains active, with a target action date of 8/22/2026. A completed FDA inspection resulted in one observation; Capricor says it does not believe the observation affects the integrity or reliability of the trial data.

Key Figures

• HOPE-3 enrolled 106 participants and met its primary endpoint: Deramiocel slowed upper-limb function decline by 54% vs placebo on PUL 2.0 (p=0.03).
• Updated LVEF analysis: treatment difference 1.8 percentage points (p=0.09), vs the previously reported 2.4 points (p=0.04). In the prespecified cardiomyopathy subgroup, the difference was 2.8 points (p=0.02). The primary efficacy endpoint and other trial data were unchanged; other additional type-1 error-controlled endpoints will be characterized as nominally significant under the applicable hierarchical testing procedures.
• FDA inspection of clinical operations related to the BLA ran from 7/6/2026 to 7/20/2026. The FDA cited one observation primarily involving standard operating procedures, documentation, vendor oversight and audit-report timeliness; Capricor is preparing a response.

Investor Takeaways

• Watch the FDA’s decision by the 8/22/2026 target action date.
• The FDA’s assessment of the inspection response and the updated LVEF analysis will be relevant to the ongoing BLA review.