Acute myeloid leukemia (AML)
MBRXMoleculin BiotechCatalyst overview
Research summary
This catalyst tracks a Phase 2/3 data readout for Annamycin + Ara-C (Cytarabine) in Acute myeloid leukemia (AML). The expected timing is based on the latest available company guidance and may change.
05/15/26:- 45 enrolled; 40% blinded CRc persists. June unblinding; 90-subject data Q3 2026; Part B H2 2026. 05/21/26:- ASCO poster May 30, 2026 shows pooled cardiac safety; no cardiotoxicity. 05/29/26:- MIRACLE Ph2b/3 unblinding of first 45 remains on track for June 2026. Cleveland Clinic review found no cardiotoxicity. 06/04/26:- 45th subject enrolled; interim 45-subject unblinding remains on track for Mid-2026. 06/30/26:- MIRACLE interim unblinded efficacy favored Annamycin+HiDAC vs control; iDMC recommended continue; Part A 67/90 enrolled. 07/31/26:- MIRACLE blinded CRc 37% (n=62); 90th treated Sep 2026; Part A unblinding Dec 2026–Feb 2027. 08/14/26:- MIRACLE interim data showed higher remission rates and no cardiotoxicity. Part A enrollment will complete in September 2026; 90-subject unblinding will occur December 2026–February 2027. Part B will begin in H1 2027.
Verification
Confirm timing and program details against the company announcement or filing.