secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2023-12-11T23:59:59+00:00
Accession:  0001558370-23-019717
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Capricor Phase 3 HOPE-3 trial of CAP-1002 in DMD passes interim futility analysis; milestone payment triggered
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- Positive interim futility analysis from DSMB; trial to continue as planned.
- Triggers first milestone payment under U.S. agreement with Nippon Shinyaku.
- HOPE-3 Cohort A enrollment complete; topline data expected Q4 2024.
- Company plans to request FDA meeting in Q1 2024 for expedited approval pathways.
- Cohort B enrollment initiated; ~102 subjects total across both cohorts.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000155837023019717/0001558370-23-019717-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000155837023019717/capr-20231211x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-019717

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