other material
confidence high
sentiment positive
materiality 0.90
Moleculin enrolls 45th subject in MIRACLE AML trial; interim data unblinding on track for mid-2026
Moleculin Biotech, Inc.
- 45th subject enrolled in pivotal Phase 2B/3 MIRACLE trial of Annamycin + cytarabine (AnnAraC) for R/R AML.
- Interim unblinding of first 45 subjects remains on track for mid-2026; CEO calls it potentially the most important data moment.
- Early blinded data among first 30 patients showed 40% composite complete remission rate (30% CR, 10% CR with partial hematologic recovery).
- Approximately 35% of subjects had previously failed venetoclax-based therapies; many had adverse genetic markers.
- Enrollment progressing toward 90-subject Part A completion expected in Q3 2026; Phase 3 design to follow dose determination.