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Hagens Berman Alerts Capricor Therapeutics, Inc. (CAPR) Investors to FDA Review Extension for Deramiocel Amid Ongoing Securities Class Action and September 28 Lead Plaintiff Deadline

$CAPRPress releaseSep 22, 2026, 6:22 PM ETRead the release

Hagens Berman issued an investor alert reminding Capricor Therapeutics (CAPR) shareholders of the September 28, 2026 lead plaintiff deadline in the pending securities class action. The release recaps the case backdrop: allegedly undisclosed post-hoc changes to the HOPE-3 statistical analysis plan, a 64% one-day stock collapse to $7.00 on July 27, 2026, and a 9-3 Advisory Committee vote against deramiocel's efficacy in Duchenne muscular dystrophy. It also notes the FDA extended the deramiocel BLA PDUFA date from August 22 to November 22, 2026 after Capricor's post-AdCom submission was classified as a major amendment.

Key figures

Adcom vote
9-3 against efficacy
Class period end
July 26, 2026
Class period start
Dec. 17, 2025
One day stock drop
64%
Pdufa date extended to
Nov. 22, 2026
Lead plaintiff deadline
Sept. 28, 2026

AI analysis

Red flags3 · Pro

The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.

AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.

    CAPR: Hagens Berman Alerts Capricor Therapeutics, Inc. (CAPR) Investors to FDA Review Extension for Deramiocel Amid Ongoing Securities Class Action and September 28 Lead Plaintiff Deadline — AI Analysis | Signal8