Moleculin Completes Part A Dosing in Pivotal MIRACLE AML Trial; Data Due Q1 2027
MBRX has more than doubled off its 52-week low of $3.228.
Summary
Moleculin completed dosing in Part A of its pivotal MIRACLE AML trial, with the full 90-patient data readout still targeted for Q1 2027. The milestone keeps the program on schedule, though the company reiterates it needs substantial new financing to fund the trial.
Key Events · Product Development and Regulatory · MBRX
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Part A Dosing Completed
Moleculin finished dosing the fully treated, randomized, double-blind n=90 Part A population of the pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory AML.
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Q1 2027 Data Readout on Track
Comprehensive Part A data is still expected in the first quarter of 2027 and is intended to support selection of the Annamycin dose for Part B.
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Broader Patient Mix Expected
The final Part A population is expected to be roughly 50/50 between patients who failed 7+3 chemotherapy and those who failed venetoclax-based regimens, versus about 70/30 among the first 45 subjects.
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Financing Need Reiterated
The release states Moleculin will require significant additional financing, for which it has no commitments, to conduct its clinical trials as described.
Analysis · MBRX · Life Sciences
Moleculin has finished dosing the 90-patient randomized Part A of its pivotal MIRACLE trial of AnnAraC in relapsed/refractory AML, keeping the comprehensive data readout on track for Q1 2027. That readout is the binary event for the whole thesis: it drives the Part B dose selection and, if the Annamycin arms beat the concurrent control, the path toward approval. The company also flagged that the final population should be roughly 50/50 between patients who failed 7+3 chemotherapy and those who failed venetoclax regimens, versus about 70/30 in the first 45 subjects, which broadens the readout's relevance. Against that, the press release itself repeats that Moleculin will need significant additional financing with no commitments in place, and the stock is a micro-cap that just did a 1-for-20 reverse split to stay listed. Execution progress is real, but the value hinges on data that is still a quarter-plus away.
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At the time of this filing, MBRX was trading at $8.70 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $9.2M. The 52-week trading range was $3.23 to $315.00. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.