Moleculin's Annamycin Interim Data Accepted for ASH; DMC Clears Trial to Continue
MBRX has more than doubled off its 52-week low of $3.228 on light trading volume (0.3× avg).
Summary
Moleculin's Annamycin abstract with first interim MIRACLE trial data was accepted for the December ASH meeting, showing 43% and 36% complete remission rates versus 12% for placebo, with the independent Data Monitoring Committee recommending the trial continue unchanged.
Key Events · Product Development and Regulatory · MBRX
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Interim Remission Rates Beat Placebo
Among the first 45 randomized patients, complete remission rates were 43% and 36% in the two Annamycin treatment arms versus 12% in the placebo arm.
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DMC Clears Trial to Continue Unchanged
The independent Data Monitoring Committee recommended the study continue without amendment, with all three treatment arms maintained.
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No Cardiotoxicity Signals Through Cutoff
No signs, symptoms or echocardiographic findings suggestive of cardiotoxicity were observed through the data cutoff; cardiac safety data will get independent expert and DMC review at the second interim analysis.
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ASH Poster Presentation in December
The abstract was accepted as a poster at the 68th ASH Annual Meeting, December 12-15, 2026, in New Orleans.
Analysis · MBRX · Life Sciences
The first prespecified interim look at the pivotal MB-108 MIRACLE trial shows complete remission rates of 43% and 36% in the two Annamycin arms versus 12% in placebo across the first 45 randomized patients, with no cardiotoxicity findings through the data cutoff. Equally important, the independent Data Monitoring Committee recommended the study continue without amendment with all three arms intact — the trial is not stopped or modified, which is the outcome that matters most for a company whose entire equity story rests on this program. Against a backdrop of going-concern doubt and a Nasdaq delisting determination previously disclosed, positive pivotal data is the one lever that can change the financing picture; the second interim analysis is expected in early 2027 and remains the next hard checkpoint.
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