secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2025-01-02T23:59:59+00:00
Accession:  0001558370-25-000010
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Capricor submits BLA for deramiocel to FDA for DMD cardiomyopathy; receives $10M milestone
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- BLA for deramiocel (cell therapy) submitted to FDA for DMD cardiomyopathy on Jan 2, 2025.
- Submission triggers $10M milestone payment from partner Nippon Shinyaku to Capricor.
- If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.
- Priority review requested; if granted, review timeline reduced to ~6 months from acceptance.
- Deramiocel holds Orphan Drug, RMAT (US), ATMP (EU) designations; potential PRV if approved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/0001558370-25-000010-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/capr-20250102x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-000010

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer