Moleculin Biotech Completes Dosing in Phase 2/3 MIRACLE Trial for AnnAraC

Moleculin Biotech reported interim Phase 2/3 trial results showing 43% and 36% remission rates in two Annamycin arms, compared to 12% with placebo. The Data Monitoring Committee recommended continuing the study. The next update is expected in early 2027.

Moleculin Biotech (MBRX) reported interim Phase 2/3 trial data for Annamycin in relapsed/refractory AML, showing 43% and 36% remission rates vs. 12% on placebo. The study will continue, with results to be presented at the 2026 ASH Annual Meeting. If successful, it could support a New Drug Application submission.

Moleculin Biotech completed dosing in Part A of its MIRACLE trial for AnnAraC, a treatment for relapsed or refractory AML, with 90 patients. Data analysis is expected in Q1 2027 to determine the dose for Part B. The trial includes patients who failed 7+3 and venetoclax-based regimens, according to the company.

Moleculin Biotech, Inc. (MBRX) filed an SEC Form 8-K — Regulation FD Disclosure. Exhibit 99.1 Moleculin Completes Dosing Patients in Part A of Pivotal MIRACLE Trial; Comprehensive Data Readout on Track for Q1 2027 Milestone underscores execution of pivotal Phase 2/3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute mye

Moleculin Biotech (MBRX) completed dosing for 90 patients in Part A of its Phase 2/3 MIRACLE trial for Annamycin in treating relapsed or refractory acute myeloid leukemia (AML). The company expects to report comprehensive data in Q1 2027, which will support dose selection for Part B. Annamycin is designed to avoid multidrug resistance and lacks cardiotoxicity common with other treatments.

Myriad Genetics (MYGN) surged 40% after agreeing to sell its Prenatal Health business to Labcorp for $210M. Moleculin Biotech (MBRX) rose 15% on AML trial progress. Femasys (FEMY) and Revolution Medicines (RVMD) each gained 7% on commercial and clinical developments.