Moleculin Announces Plans For MIRACLE Adaptive Phase 3 Clinical Trial Designed For Possible Accelerated Approval Of Annamycin In Combination With Cytarabine For The Treatment Of Relapsed Or Refractory AML
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Moleculin Biotech, Inc. (NASDAQ: MBRX) announced plans for a pivotal, adaptive Phase 3 clinical trial (MIRACLE trial) for the possible accelerated approval of Annamycin in combination with Cytarabine for treating relapsed or refractory AML. The decision follows a positive discussion with the FDA.
August 01, 2024 | 12:36 pm
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Moleculin Biotech, Inc. (MBRX) plans to proceed with a Phase 3 clinical trial for Annamycin in combination with Cytarabine, targeting accelerated FDA approval for treating relapsed or refractory AML. This follows a positive discussion with the FDA.
The announcement of a Phase 3 trial for a potential accelerated approval of a new treatment for relapsed or refractory AML is a significant milestone for Moleculin Biotech. Positive FDA discussions and the potential for accelerated approval are likely to boost investor confidence and positively impact the stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100