Moleculin (MBRX) Completes Part A Dosing in Pivotal AML Trial; Data Readout Set for Q1 2027

Moleculin Biotech (MBRX) said it completed patient dosing in Part A of its pivotal Phase 2/3 MIRACLE trial testing Annamycin combined with cytarabine (AnnAraC) in adults with relapsed or refractory acute myeloid leukemia, with comprehensive data expected in the first quarter of 2027. Shares fell 7.45% to $8.07. The randomized, double-blind Part A enrolled 90 patients, comparing two doses of Annamycin plus cytarabine against a cytarabine-plus-placebo control arm, evaluating outcomes after a single treatment cycle. Moleculin said blinded interim data have shown no evidence of cardiotoxicity. The final Part A population is expected to include roughly equal representation of patients previously treated with intensive 7+3 chemotherapy and venetoclax-based regimens, versus a 70/30 split among the first 45 patients. The readout will support selection of the optimal Annamycin dose for advancement into Part B.