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Moleculin Biotech Gets FDA Nod for Phase 3 Trial

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Moleculin Biotech Gets FDA Nod for Phase 3 Trial

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An update from Moleculin Biotech ( (MBRX) ) is now available.

On February 13, 2025, Moleculin Biotech announced receiving FDA feedback that allows a reduced size for its Phase 3 trial protocol evaluating Annamycin combined with Cytarabine for treating relapsed or refractory AML. This trial, named MIRACLE, will be conducted globally, including in the US, Europe, and the Middle East, and aims to accelerate the approval timeline for this potentially groundbreaking non-cardiotoxic anthracycline. The feedback enables quicker site openings and recruitment, with implications for significantly impacting AML treatment and eliminating cardiotoxic risks in cancer therapies.

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. Its lead program, Annamycin, aims to overcome multidrug resistance and eliminate cardiotoxicity associated with traditional anthracyclines. The company is also exploring treatments for brain tumors, pancreatic cancer, and pathogenic viruses.

YTD Price Performance: -76.27%

Average Trading Volume: 160,613

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $1.75M

Learn more about MBRX stock on TipRanks’ Stock Analysis page.

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