Shareholders Filed a Lawsuit Against Capricor for Misleading Investors About FDA Approval

Court: S.D. California

Case: 3:25-cv-01815

On July 17, 2025, CAPR shareholders have filed a class action against Capricor Therapeutics, accusing it of misleading the market about deramiocel’s FDA approval prospects.

What is this lawsuit about?

Between October 9, 2024, and July 10, 2025, Capricor promoted its lead therapy, deramiocel (CAP-1002), as likely to receive accelerated FDA approval for cardiomyopathy associated with Duchenne muscular dystrophy. Executives emphasized positive Phase 2 trial results and downplayed regulatory hurdles.

However, the company concealed significant regulatory concerns. On June 26, 2025, Capricor revealed that the FDA had canceled its advisory committee meeting. CAPR dropped 26.4%. Then, on July 11, 2025, the company disclosed that it had received a Complete Response Letter from the FDA, rejecting approval due to insufficient evidence. The stock fell another 36.3%, bringing the total decline to 62.7%.

What can you do to recover your losses now?

We’re keeping track of all updates and will notify CAPR investors about potential recovery.

More than 600 companies are currently facing securities class action lawsuits, and over 100 are already paying settlements. Connect your brokerage account to automatically check which ones you may have missed.