secwatch.observer — SEC 8-K summary
======================================

Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2026-03-10T23:59:59+00:00
Accession:  0001104659-26-025657
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA lifts CRL for Deramiocel BLA; new PDUFA date August 22, 2026
----------------------------------------------------------------

- FDA resumed review of Deramiocel BLA for Duchenne muscular dystrophy cardiomyopathy after lifting CRL.
- Submission classified as Class 2 resubmission; PDUFA target action date set for August 22, 2026.
- BLA supported by positive HOPE-3 Phase 3 trial meeting primary and all secondary endpoints.
- Company expects to be eligible for a Priority Review Voucher upon potential approval.
- FDA has not identified any review issues in its response to Capricor at this time.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/0001104659-26-025657-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/capr-20260310x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-025657

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