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
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
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