secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2026-05-12T20:06:21+00:00
Accession:  0001104659-26-059380
Event type: earnings
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Capricor Q1 net loss $33.9M ($0.59/share); Deramiocel BLA PDUFA Aug 22, 2026
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- Net loss of $33.9M ($0.59/share) for Q1 2026 vs net loss of $24.4M ($0.53/share) in Q1 2025.
- Cash balance of $278.6M as of March 31, 2026; expected to support operations through Q4 2027.
- Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected soon.
- Filed suit against Nippon Shinyaku/NS Pharma citing flawed pricing in distribution agreement; seeking rescission and preliminary injunction.
- New Chief Commercial Officer with direct DMD experience expected to join in coming weeks; eligible for Priority Review Voucher upon approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/0001104659-26-059380-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/capr-20260512x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-059380

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