Hagens Berman sets Sept. 28 lead plaintiff deadline in Capricor case
Hagens Berman says investors in Capricor Therapeutics who bought shares during the stated class period may seek lead plaintiff status in a securities case tied to an FDA review delay.
Hagens Berman Sobol Shapiro LLP said Sept. 3 that it is notifying investors in Capricor Therapeutics Inc. of a Sept. 28, 2026 lead plaintiff deadline in a securities class action tied to the company’s lead cell therapy candidate, deramiocel.
The notice says the case concerns Capricor’s disclosure that the Food and Drug Administration extended review of the company’s biologics license application for deramiocel, a treatment being studied for Duchenne muscular dystrophy. The firm said the deadline applies to investors who bought or acquired Capricor securities between Dec. 17, 2025, and July 26, 2026, and suffered losses.
Hagens Berman said the FDA moved the target action date for the application from Aug. 22, 2026, to Nov. 22, 2026, after classifying Capricor’s recent submission as a major amendment.
According to the notice, the submission came after a July 2026 advisory committee meeting and included 24-month open-label extension data from the Phase 3 HOPE-3 study. The company also asked the FDA to narrow the proposed indication to upper limb function only.
The source is a law-firm press release and not an independent finding on the merits of the claims. Hagens Berman said the securities case is focused on how Capricor management characterized trial endpoints and an undisclosed modification. Reed Kathrein, a partner at the firm, was quoted in the alert.
The notice says investors do not need to become lead plaintiff to share in any potential recovery. It also points readers to the SEC Whistleblower program, which the firm said can pay awards of up to 30% of a successful SEC recovery.
Capricor’s extended FDA review date now stands at Nov. 22, 2026, and the lead plaintiff deadline in the notice is Sept. 28, 2026.
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