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CAPRICOR THERAPEUTICS, INC. (CAPR) filed an 8-K current report with the SEC on August 24, 2026 reporting Item 8.01 (Other Events). FDA PDUFA action date extended to November 22, 2026 from August 22, 2026.
CAPRICOR THERAPEUTICS, INC. 8-K event analysis
AI summary of each reported item and its exhibits
Item 8.01 · Other Events
- FDA PDUFA action date extended to November 22, 2026 from August 22, 2026
- Three-month delay reflects FDA classification of Deramiocel BLA amendment as major
- Amendment adds 24-month HOPE-3 open-label data and analyses supporting refined upper-limb-function indication
- Deramiocel remains under FDA review for Duchenne muscular dystrophy, with approval timing pushed back structurally
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