secwatch.observer — SEC 8-K summary
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Issuer:     Moleculin Biotech, Inc. (MBRX)
CIK:        0001659617
Form:       8-K
Filed at:   2025-11-13T23:59:59+00:00
Accession:  0001437749-25-034635
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Moleculin reports 60% enrollment for first interim unblinding of Phase 3 AML trial
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- 60% of target 45 subjects for first interim unblinding of MIRACLE (R/R AML) trial have consented (as of Nov 4, 2025).
- Completion of treatment for first 45 subjects expected Q1 2026; unblinding thereafter.
- Blinded response activity tracking within expected range based on historical trial arm responses.
- CEO notes strong recruitment momentum despite EU bed shortages.
- Annamycin has FDA Fast Track and Orphan Drug designations for R/R AML; patent protection through 2040-2045.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659617/000143774925034635/0001437749-25-034635-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659617/000143774925034635/mbrx20251112_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-034635

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