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Moleculin Biotech Gains European Approval for Phase 3 Trial

Story Highlights
  • Moleculin received approval in Europe to start recruiting for its Phase 3 MIRACLE trial.
  • The approval advances Moleculin’s trial and aims for preliminary data by late 2025.
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Moleculin Biotech Gains European Approval for Phase 3 Trial

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The latest update is out from Moleculin Biotech ( (MBRX) ).

On February 11, 2025, Moleculin Biotech announced receiving regulatory approval in Europe to start recruiting for its Phase 3 MIRACLE trial, evaluating Annamycin combined with Cytarabine for treating relapsed or refractory acute myeloid leukemia. The trial will include sites in the US, Europe, and the Middle East. The announcement signifies a crucial step in advancing their pivotal clinical trial, aiming for unblinded preliminary data from the first 45 subjects in the second half of 2025, potentially enhancing their market position in cancer therapeutics.

More about Moleculin Biotech

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses. Their lead program, Annamycin, aims to overcome multidrug resistance and reduce cardiotoxicity related to anthracyclines, targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The company is also working on other treatments targeting cancer and pathogenic viruses.

YTD Price Performance: -60.23%

Average Trading Volume: 95,370

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $2.7M

See more data about MBRX stock on TipRanks’ Stock Analysis page.

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