secwatch.observer — SEC 8-K summary
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Issuer:     Moleculin Biotech, Inc. (MBRX)
CIK:        0001659617
Form:       8-K
Filed at:   2026-02-18T23:59:59+00:00
Accession:  0001437749-26-004455
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Moleculin reports 40% blinded CRc in MIRACLE trial; 35 subjects treated, unblinding on track for Q1 2026
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- Preliminary blinded composite CR rate of 40% (30% CR, 10% CRh) in first 30 subjects; 67% above historical cytarabine CR.
- 35 subjects treated to date with 11 in screening; targeting first unblinding at 45 subjects, on track for Q1 2026 treatment milestone.
- Roughly 35% of treated subjects are venetoclax regimen failures, a challenging population with high unmet need.
- Continued absence of cardiotoxicity cited; Annamycin holds FDA Fast Track and Orphan Drug Designation for R/R AML.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926004455/0001437749-26-004455-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926004455/mbrx20260216c_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-004455

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