- Lead plaintiff deadline is September 28, 2026.
- Class period: December 17, 2025 to July 26, 2026.
- Lawsuit alleges Capricor adopted changes to the pre-specified statistical analysis plan for Deramiocel without FDA agreement.
- FDA had not agreed to those changes before Capricor resubmitted the BLA.
- Risk that FDA could conclude no substantial evidence of effectiveness.
- Risk to regulatory approval of Deramiocel for Duchenne muscular dystrophy.
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