Moleculin Biotech Completes Part A Enrollment in Phase 2/3 MIRACLE Trial for Relapsed AML

Moleculin Biotech (MBRX) said it completed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in adults with relapsed or refractory acute myeloid leukemia. The stock traded at $0.56 on Sept. 29, 2026, down 0.04%. Part A enrolled 89 patients, with one more in screening. The randomized, double-blind stage compares two Annamycin doses plus cytarabine against cytarabine plus placebo over one treatment cycle. Moleculin expects a roughly 50/50 split between prior intensive 7+3 chemotherapy and venetoclax-based regimens. Comprehensive Part A data are due in the first quarter of 2027 and will guide dose selection for Part B. Moleculin reported no cardiotoxicity in blinded data to date. It cautioned that single-cycle remission results may not be comparable with historical multi-cycle studies. MBRX has traded between $0.16 and $15.75 over the past year.