Moleculin Receives Institutional Review Board Approval for MIRACLE Phase 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R Acute Myeloid Leukemia (AML)
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Moleculin Biotech, Inc. has received Institutional Review Board approval for its Phase 3 pivotal trial, named 'MIRACLE', to evaluate Annamycin in combination with Cytarabine for treating relapsed or refractory Acute Myeloid Leukemia (AML). The trial is set to begin in the first quarter of 2025 and aims for possible accelerated approval.
November 12, 2024 | 1:15 pm
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Moleculin Biotech has received IRB approval for its Phase 3 trial of Annamycin with Cytarabine for AML, potentially accelerating the drug's approval process.
The IRB approval is a significant regulatory milestone for Moleculin, indicating progress towards the potential accelerated approval of Annamycin. This could positively impact MBRX's stock as it shows advancement in their drug development pipeline.
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