Why Did Capricor Plunge 46.32%? FDA Rejects Deramiocel

On July 11, 2025, Capricor's stock plummeted by 46.32% in pre-market trading, marking a significant downturn for the biotechnology company.

Capricor Therapeutics received a Complete Response Letter from the FDA regarding its Biologics License Application (BLA) for Deramiocel, a cell therapy aimed at treating Duchenne Muscular Dystrophy. The FDA cited insufficient evidence as the reason for the rejection, prompting Capricor to plan a resubmission of its BLA in the third quarter of 2025. This resubmission will include data from the ongoing Phase 3 HOPE-3 trial, which is crucial for demonstrating the therapy's efficacy and safety.

The FDA's decision to decline approval for Deramiocel has raised concerns about the regulatory hurdles Capricor faces in bringing its innovative therapies to market. The company's stock price has been volatile in response to these regulatory updates, reflecting investor uncertainty about the future of Deramiocel and other pipeline products.

Capricor's strategy to address the FDA's concerns involves leveraging the Phase 3 HOPE-3 trial data, which is expected to provide robust evidence supporting Deramiocel's clinical benefits. The company's ability to navigate this regulatory challenge will be critical in determining its long-term success and investor confidence.