CAPR Class Action: Capricor Therapeutics Investors are Notified of the Upcoming September 28 Deadline in Ongoing Securities Fraud Class Action over Clinical Data

Capricor Therapeutics, Inc. has been sued for securities fraud over alleged misstatements about Deramiocel and the integrity of the clinical data supporting its Biologics License Application leading to a 64% stock drop. NEW YORK , Sept. 22, 2026 /PRNewswire/ -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Capricor Therapeutics, Inc. ( NASDAQ: CAPR ) and certain of the company's senior executives for securities fraud after its significant stock drop resulting from potential violations of the federal securities laws.

Key Details of the Capricor Therapeutics ($CAPR) Class Action: Lead Plaintiff Deadline: September 28, 2026 Lawsuit Allegations: Securities fraud alleging Capricor made false statements concerning Deramiocel and the integrity of the clinical data supporting its Biologics License Application. Largest Alleged Stock Drop: July 27, 2026 – 64.5% Stock Drop Court: U.S. District Court for the Southern District of California

Investors have until September 28, 2026 to ask the Court to be appointed to lead the case. The complaint asserts securities fraud claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Capricor securities. The class action is pending in the U.S. District Court for the Southern District of California. It is captioned Nkamga v. Capricor Therapeutics, Inc. et al. , No. 26-cv-04385.

Why is Capricor Being Sued for Securities Fraud ? Capricor is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases. Its lead product candidate, Deramiocel, is an investigational cell therapy being developed for Duchenne muscular dystrophy. According to the complaint, Capricor submitted a Biologics License Application to the FDA for Deramiocel in late 2024. In July 2025, the FDA issued a Complete Response Letter stating that the application did not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data was needed.

As alleged , Capricor failed to disclose that it adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel and that the FDA had not agreed to those changes before Capricor resubmitted the Deramiocel BLA.

Why did Capricor's Stock Drop? On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting concerning Deramiocel. The FDA briefing documents reportedly raised concerns about post-hoc changes to Capricor's statistical analysis plan, including changes to the methodology for calculating the primary endpoint, PUL 2.0, shortly before the database was unlocked and unblinded. This news caused the price of Capricor stock to decline $12.70 per share, or 64.5%, from a closing price of $19.70 per share on July 24, 2026, to $7.00 per share on July 27, 2026, the following trading day.

On July 29, 2026, the FDA advisory committee met to discuss the Deramiocel BLA. The next day, a medical news website named Medscape reported that in a non-binding 9-3 vote, the panel concluded that available evidence did not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy. On this news, Capricor's stock dropped $2.38 per share, or 36%, from a closing price of $6.57 per share on July 29, 2026, to $4.19 per share on July 30, 2026.

What Can You Do? If you invested in Capricor Therapeutics securities, you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis; there is no cost to you. Shareholders are not responsible for any court costs or expe...