Moleculin Biotech reports interim AML trial remission rates of 43% and 36% versus 12% placebo

Moleculin Biotech (MBRX) released interim data from its pivotal Phase 2/3 MIRACLE trial of Annamycin combined with cytarabine in relapsed/refractory AML. Among the first 45 randomized patients, complete remission was achieved in 43% and 36% of the two Annamycin arms, compared with 12% on placebo. The independent Data Monitoring Committee advised that the study continue without modification, and the abstract has been accepted for presentation at the ASH Annual Meeting in December 2026.

The company says the strong remission rates could support a future New Drug Application submission, which may increase the stock’s valuation if the trial proceeds successfully. The next interim analysis is slated for early 2027, providing a timeline for further data releases.

  • 1Complete remission rates were 43% and 36% in the two Annamycin arms, versus 12% on placebo.
  • 2The interim analysis included the first 45 randomized patients evaluated.
  • 3The independent Data Monitoring Committee recommended continuing the study without modification.
  • 4An abstract of the data was accepted for poster presentation at the 68th ASH Annual Meeting, scheduled for Dec 12‑15 2026.
  • 5The second interim analysis is expected in early 2027.

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