other material
confidence high
sentiment positive
materiality 0.85
Moleculin reports 40% blinded CRc in MIRACLE trial; 35 subjects treated, unblinding on track for Q1 2026
Moleculin Biotech, Inc.
- 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.