Moleculin Biotech Announces Part A Enrollment Completion in MIRACLE Trial

What Happened

• Moleculin Biotech (MBRX) filed an 8‑K on September 29, 2026 (Regulation FD disclosure) announcing it has completed and closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial. The trial is testing Annamycin in combination with cytarabine (AnnAraC) in adults with relapsed or refractory acute myeloid leukemia (R/R AML).
• The company reported 89 subjects enrolled in Part A, with two additional subjects currently in screening. With enrollment closed at 89 (or potentially more), Moleculin remains on track for a planned comprehensive Part A data readout in the first quarter of 2027. A press release and abstract were filed as exhibits to the 8‑K.

Key Details

• Filing date: September 29, 2026 (8‑K Regulation FD disclosure).
• Trial: MIRACLE Phase 2/3, evaluating Annamycin + cytarabine (AnnAraC) for R/R AML.
• Enrollment: 89 subjects enrolled in Part A; 2 additional subjects in screening.
• Planned data readout: Comprehensive Part A results expected Q1 2027.
• Exhibits: Press release and abstract attached to the filing (Exhibits 99.1 and 99.2).

Why It Matters

• Completion of Part A enrollment is an important operational milestone that allows the company to move forward to data analysis and prepare the planned Part A readout, a near‑term clinical milestone investors often watch closely.
• The upcoming Q1 2027 data readout will provide the first comprehensive efficacy/safety results from Part A of this pivotal trial, which could influence the program’s regulatory and development path. Investors should look for the company’s full data release and any subsequent regulatory or trial updates.