Moleculin Biotech, Inc. filed a Form 8-K on October 30, 2026, disclosing that dosing has been completed in Part A of its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for adults with relapsed or refractory acute myeloid leukemia.

Key Highlights

  • Dosing completed: Dosing has been completed in Part A of the MIRACLE trial, according to the filing.
  • Drug combination: The trial evaluates Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML).
  • Trial designation: The MIRACLE trial is described as a pivotal Phase 2/3 study.
  • Data readout timeline: The company disclosed it "remains on track to report comprehensive Part A data in the first quarter of 2027."
  • Disclosure basis: The press release was furnished under Regulation FD and is not deemed "filed" for purposes of the Securities Exchange Act of 1934.

Moleculin Biotech Reports Part A Dosing Completion in AML Study

Moleculin Biotech, Inc. (NASDAQ:MBRX), a Houston, Texas-based biopharmaceutical company, issued a press release on October 30, 2026, announcing a milestone in its MIRACLE trial. According to the filing, dosing has been completed in Part A of the pivotal Phase 2/3 study, which evaluates the combination of Annamycin with cytarabine, referred to as AnnAraC, for adults diagnosed with relapsed or refractory acute myeloid leukemia (R/R AML).

The company disclosed that it "remains on track to report comprehensive Part A data in the first quarter of 2027." The press release, attached as Exhibit 99.1, was incorporated by reference into the filing. The filing was signed by Jonathan P. Foster on behalf of the registrant.

The disclosure was made under Item 7.01 (Regulation FD Disclosure) of the Form 8-K. The filing notes that the information furnished under Item 7.01, including the attached press release, "shall not be 'filed' for the purpose of the Securities Exchange Act of 1934" and is not incorporated by reference into other filings under the Exchange Act or the Securities Act of 1933 unless specifically identified as such.

What Was Disclosed

Moleculin Biotech filed an 8-K on October 30, 2026, reporting completion of patient dosing in Part A of its Phase 2/3 MIRACLE trial for R/R AML using AnnAraC, with comprehensive Part A data expected in the first quarter of 2027.