other material
confidence high
sentiment positive
materiality 0.75
Moleculin reports 60% enrollment for first interim unblinding of Phase 3 AML trial
Moleculin Biotech, Inc.
- 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.