Capricor faces securities class action over Deramiocel disclosures

By Atlas Watchline Staff · Legal · August 27, 2026

A securities fraud class action filed in federal court alleges Capricor Therapeutics misled investors about Deramiocel clinical data and a BLA resubmission.

A securities fraud class action filed in federal court alleges Capricor Therapeutics misled investors about Deramiocel clinical data and a BLA resubmission.

A securities fraud class action has been filed against Capricor Therapeutics in the U.S. District Court for the Southern District of California, according to a press release from Kessler Topaz Meltzer & Check, LLP. The proposed class covers people who bought or acquired Capricor securities between Dec. 17, 2025, and July 26, 2026, inclusive.

The complaint centers on claims that the company misstated or withheld information about Deramiocel, a product tied to Capricor’s regulatory prospects. The release says investors have until Sept. 28, 2026, to seek lead-plaintiff status.

According to the press release, the case is captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.). The allegations say Capricor changed the pre-specified statistical analysis plan used to analyze Deramiocel clinical data and did not have FDA agreement to those changes before resubmitting its Biologics License Application.

The release says the FDA published briefing documents on July 27, 2026, ahead of its July 29 advisory committee meeting for Deramiocel’s BLA. Those documents reportedly said Capricor changed the analysis plan, did not submit the final version to the FDA for review before the BLA submission, and that the issue was not discussed and therefore not agreed upon.

The press release also says the FDA wrote that it did not consider the conversion of raw change to percent change and back to raw change scientifically justified. It further says the briefing documents stated the benefit-risk assessment for deramiocel appeared unfavorable absent evidence of effectiveness.

According to the release, Capricor stock fell 64% after the FDA briefing documents were published.

The filing itself and the company’s response were not included in the press release. The release says the complaint was not filed by KTMC, which issued the notice on behalf of investors.

KTMC said investors may contact attorney Jonathan Naji and that there is no cost or obligation to speak with an attorney. The firm described itself as a securities-litigation plaintiff firm with offices in Pennsylvania and California.

Next is the Sept. 28 deadline for investors who want to ask the court to appoint them lead plaintiff in the case.

Sources

• PR Newswire / Kessler Topaz Meltzer & Check, LLP press release

Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.

This is the AMP version of the article. Read the full article on Atlas Watchline.