Capricor Therapeutics published a peer‑reviewed study in Biomedicines on November 3, 2025, describing a novel in‑vitro potency assay for its lead product Deramiocel.
The assay measures anti‑fibrotic activity by quantifying suppression of collagen I and III gene expression in primary human fibroblasts. It was validated across more than 100 manufacturing lots, confirming consistent potency of the cardiosphere‑derived cell product.
The study provides a reproducible potency metric that addresses the FDA’s request for additional efficacy evidence following the July 2025 Complete Response Letter. The validated assay supports Capricor’s plan to resubmit its Biologics License Application for Deramiocel’s Duchenne muscular dystrophy indication and strengthens the company’s regulatory strategy.
Capricor’s partnership with Nippon Shinyaku Co., Ltd. (NS Pharma) for U.S. and Japan commercialization, combined with Deramiocel’s orphan drug designation from the FDA and EMA and its RMAT designation in the U.S., positions the company to advance the product through regulatory approval. The company also expects topline data from the Phase 3 HOPE‑3 trial in the fourth quarter of 2025, which will further inform the BLA resubmission.
The publication of the study in Biomedicines, a journal with a 2024 impact factor of 3.9, adds scientific credibility to the assay and demonstrates Capricor’s commitment to rigorous quality control and regulatory compliance.
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