--- title: "Capricor discloses new securities class action and derivative suit" url: "https://aibio.space/news/capricor-discloses-new-securities-class-action-derivative-suit-fda/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-08-14" section: "Legal" tickers: "NASDAQ:CAPR" source: "https://www.sec.gov/Archives/edgar/data/1133869/000110465926097294/capr-20260630x10q.htm" summary: "Defendants: Capricor and unnamed officers in the new July 30 class action, and Capricor and CEO Linda Marbán in the 2025 one. The FDA also moved the derami" --- By the aibio.space news desk. Sources - [Capricor Therapeutics 10-Q (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1133869/000110465926097294/capr-20260630x10q.htm) - [Capricor 8-K, PDUFA extension, Aug 24, 2026](https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm) - [Capricor 10-K for 2025 (directors, CEO named in 2025 suit)](https://www.sec.gov/Archives/edgar/data/1133869/000110465926029580/capr-20251231x10k.htm) [CAPR](https://aibio.space/companies/capricor-therapeutics/) 2026-08-14 # Capricor discloses new securities class action and derivative suit as FDA date slips Tickers [CAPR](https://aibio.space/companies/capricor-therapeutics/) Defendants: Capricor and unnamed officers in the new July 30 class action, and Capricor and CEO Linda Marbán in the 2025 one. The FDA also moved the deramiocel date to November 22, 2026. ## Key facts - **Company**: Capricor Therapeutics, Inc. (NASDAQ: CAPR) - **News type**: Legal - **Primary source**: [Capricor Therapeutics 10-Q (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1133869/000110465926097294/capr-20260630x10q.htm) *The facade of a neoclassical court building at dusk. Photo: Carol M Highsmith, CC0, via rawpixel. The picture shows the field, not the companies named.* Capricor Therapeutics, Inc. (Nasdaq: [CAPR](https://aibio.space/companies/capricor-therapeutics/)) disclosed a new securities class action and a new derivative action in its [10-Q for the quarter ended June 30, 2026](https://www.sec.gov/Archives/edgar/data/1133869/000110465926097294/capr-20260630x10q.htm), filed August 14. The class action was filed on July 30, 2026 by Darren Ngasseu Nkamga, individually and on behalf of others, and a derivative action followed on August 7, 2026 in the Southern District of California. On August 24 the company reported in an [8-K](https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm) that the FDA had moved the target action date for its deramiocel application from August 22 to November 22, 2026. ## Who is named The defendants in the July 30 class action are Capricor and "certain officers of the Company." The 10-Q does not name those officers. The earlier securities class action, filed July 17, 2025 in the Southern District of California, names Capricor and its chief executive officer, Linda Marbán, according to the company's [10-K for 2025](https://www.sec.gov/Archives/edgar/data/1133869/000110465926029580/capr-20251231x10k.htm). Two earlier derivative actions, filed August 1 and November 24, 2025 in the same court, name each director on the board; neither filing lists them. ## The allegations All of this is allegation. The Nkamga complaint says the defendants made materially false or misleading statements about Capricor's business, operations and prospects. The 10-Q gives no class period or case number for it. The 2025 class action alleges certain violations of federal securities laws and seeks unspecified damages. The derivative actions allege, among other things, breaches of fiduciary duties and also seek unspecified damages. Any recovery in a derivative case goes to the company. Other demands are pending. On October 2, 2025 Capricor received a Section 220 demand, dated September 30, 2025, to inspect books and records over alleged false and misleading statements by officers and directors. On May 20, 2026 it received a demand from shareholder Jennifer Godin to remedy alleged breaches of fiduciary duties. The 10-Q says no settlement amount has been requested yet. The company has not recorded any material accruals for loss contingencies as of June 30, 2026. ## Two other fights Capricor is also in court with its U.S. distributor. On May 7, 2026 it sued Nippon Shinyaku Co., Ltd and NS Pharma, Inc. in the Superior Court of New Jersey, alleging a fundamental pricing flaw in the U.S. Distribution Agreement and that NS failed to prepare for the launch of deramiocel. It seeks rescission. Capricor withdrew its preliminary injunction motion, without prejudice, before an August 10 hearing and expects arbitration to begin this fall. On July 16, 2026 Mesoblast International Sàrl sued Capricor in the District of Delaware, alleging infringement of three patents on mesenchymal stem cell compositions and methods through the manufacture, use, sale and importation of deramiocel. Mesoblast seeks an injunction, damages, attorneys' fees and a declaratory judgment. ## The FDA date and the cash Deramiocel, a cell therapy for Duchenne muscular dystrophy, has no approval, and Capricor has no product on sale. The 8-K says the FDA treated the submission as a major amendment, which adds three months to the review. The amendment includes 24-month open-label extension data from the Phase 3 HOPE-3 study and asks the FDA to review the data for a refined indication focused on upper limb function, the study's primary endpoint. Capricor reported no revenue. For the six months ended June 30, 2026 it had a net loss of $74,674,999, and cash used in operating activities was approximately $60.7 million. It held cash, cash equivalents and marketable securities of approximately $237.9 million, down from approximately $318.1 million at December 31, 2025. Management says that is enough to fund operations for at least twelve months from the issue date of the financial statements. Spending on commercial preparation continues while the litigation, the FDA review and the distributor dispute are all unresolved. The filings give no court dates for the shareholder cases. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story CAPR Capricor Therapeutics, Inc. 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Cite as: aibio.space, "Capricor discloses new securities class action and derivative suit", 2026-08-14, https://aibio.space/news/capricor-discloses-new-securities-class-action-derivative-suit-fda/