Moleculin’s AML Drug Shows Strong Early Data in Venetoclax-Failed Patients — Moleculin Biotech, Inc.

Event summary

Moleculin’s MIRACLE trial for Annamycin in relapsed/refractory AML reports interim blinded CRc of 37% in venetoclax-failed patients, significantly higher than historical salvage rates (~13%).
Enrollment reaches 74 of 90 patients, with final Part A treatment expected in September 2026 and unblinded results due December 2026–February 2027.
No evidence of cardiotoxicity observed, differentiating Annamycin from conventional anthracyclines.

The big picture

Moleculin’s positive interim data for Annamycin in a challenging patient population (venetoclax failures) positions it as a potential alternative in R/R AML, where treatment options are limited. The absence of cardiotoxicity further strengthens its profile against conventional anthracyclines. Success here could validate Moleculin’s adaptive trial design and accelerate its path to market.

What we're watching

Efficacy Validation: Whether the unblinded Part A results will confirm Annamycin’s superiority over control, particularly in venetoclax-failed patients.
Regulatory Pathway: The pace at which Moleculin advances toward Part B of the MIRACLE trial and potential FDA approval.
Partnering Opportunities: How the upcoming data readout may attract strategic partners given Annamycin’s differentiated profile.