Capricor Therapeutics Under Legal Scrutiny Over Transparency in Drug Development Claims
- Capricor Therapeutics faces legal scrutiny over alleged misleading information regarding its drug candidate, deramiocel.
- The FDA issued a Complete Response Letter to Capricor, citing insufficient evidence for deramiocel's effectiveness.
- Shareholders can join a class action lawsuit against Capricor for perceived fraudulent practices impacting their investments.
Capricor Therapeutics Faces Legal Scrutiny Over Drug Development Transparency
Capricor Therapeutics, Inc. is currently under scrutiny following allegations from shareholders regarding the company's handling of its lead drug candidate, deramiocel, designed to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The Gross Law Firm has issued a notice encouraging affected shareholders, who purchased shares between October 9, 2024, and July 10, 2025, to explore potential claims and consider joining a class action lawsuit. The allegations suggest that Capricor misled investors by promoting an optimistic outlook for securing a Biologics License Application (BLA) from the FDA while withholding critical negative data from its Phase 2 HOPE-2 trial.
The complaint highlights that Capricor promised progress in its drug development, fostering investor confidence. However, the situation took a significant downturn when the company received a Complete Response Letter from the FDA on July 11, 2025. This letter indicated that Capricor had failed to provide substantial evidence supporting the drug's effectiveness, necessitating further clinical data before any application could proceed. Following this announcement, Capricor’s stock price experienced a considerable decline, dropping from $11.40 to $7.64 per share, reflecting the investors' loss of confidence in the company’s claims regarding deramiocel's potential.
The Gross Law Firm aims to represent those investors impacted by what they perceive as fraudulent practices related to Capricor's disclosures. Shareholders interested in participating in the class action must register by September 15, 2025, although doing so does not incur any costs or obligations. By registering, shareholders gain access to updates on the case's progress through portfolio monitoring software, ensuring they remain informed about developments that could affect their interests.
In addition to the legal challenges, Capricor Therapeutics is at a critical juncture as it seeks to navigate the regulatory landscape surrounding its drug candidate. The company's ability to transparently communicate with stakeholders and regulatory bodies will be crucial in rebuilding trust and advancing deramiocel's development. As the legal situation unfolds, industry observers will closely monitor Capricor's strategic responses and its potential impact on future clinical trials and regulatory approvals.