Capricor Therapeutics Faces FDA Setback and Investor Lawsuit

SAN DIEGO, Sept. 16, 2026 /CourierPR/ -- Capricor Therapeutics, Inc., a biotechnology company focused on developing cell and exosome-based therapeutics for Duchenne muscular dystrophy, faces a significant setback after the U.S. Food and Drug Administration (FDA) released briefing documents ahead of its July 29 advisory committee meeting. These documents revealed that Capricor had made changes to the pre-specified statistical analysis plan (SAP) for its lead product candidate, Deramiocel, without the FDA's prior approval.

According to the complaint, the FDA stated that the final version of the SAP was created one day before the data was unblinded and was not submitted to the FDA for review. The FDA also commented that the conversion of raw change to percent change and back to raw change was not scientifically justified, adding complexity and reducing accuracy. Furthermore, the FDA considered the analyses based on the post-study SAP versions to be post-hoc and exploratory.

On July 27, 2026, Capricor provided an update, stating that it had engaged fully and transparently with the FDA throughout the review process. However, the company's stock price plummeted 64% on the same day, following an investor note from Cantor Fitzgerald that highlighted the FDA's concerns about the integrity of the data collection.

The advisory committee met on July 29, 2026, and relied on SAP version 1.1 as the prespecified plan. In a non-binding 9-3 vote, the panel concluded that the available evidence did not support the efficacy of Deramiocel for treating Duchenne muscular dystrophy-associated cardiomyopathy. This news caused the stock price to fall an additional 36%.

Investors who purchased or acquired Capricor securities between December 17, 2025, and July 26, 2026, have until September 28, 2026, to seek appointment as lead plaintiff in a class action lawsuit. The lawsuit, captioned Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.), alleges that Capricor and certain of its executives violated the Securities Exchange Act of 1934 by making false and misleading statements and failing to disclose the changes to the SAP.

The law firm of Robbins Geller Rudman & Dowd LLP is handling the case and is seeking to represent the interests of investors who suffered substantial losses due to the alleged misrepresentations. The firm has a history of recovering significant sums for investors, with past recoveries totaling over $8.4 billion.