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Moleculin Biotech Gains Approval for Phase 2B/3 AML Study

Story Highlights
  • Moleculin Biotech received approval in Georgia for a pivotal Phase 2B/3 trial of Annamycin for AML.
  • The trial will expand to over 30 sites in the US and Europe, with data expected in late 2025.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Moleculin Biotech Gains Approval for Phase 2B/3 AML Study

Elevate Your Investing Strategy:

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

On July 9, 2025, Moleculin Biotech announced that the Regulation Agency for Medical and Pharmaceutical Activities in Georgia approved their Clinical Trial Application for a pivotal Phase 2B/3 study of Annamycin combined with cytarabine for treating relapsed or refractory acute myeloid leukemia. This approval, along with recent European Medicines Agency approval, enhances the trial’s scope, which is set to expand to over 30 sites in the US and Europe by year-end. The trial’s initial data readout is anticipated in the second half of 2025, marking a significant milestone in Moleculin’s efforts to address unmet needs in AML treatment.

The most recent analyst rating on (MBRX) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Moleculin Biotech stock, see the MBRX Stock Forecast page.

Spark’s Take on MBRX Stock

According to Spark, TipRanks’ AI Analyst, MBRX is a Neutral.

Moleculin Biotech’s stock score reflects a high-risk financial position with no revenue and growing losses typical of early-stage biotech firms. Positive developments in clinical trials and a solid financial runway provide potential upside, but significant risks remain due to financial instability, high trial costs, and future funding needs. Technical indicators suggest bearish momentum, and the valuation is unattractive due to the absence of earnings.

To see Spark’s full report on MBRX stock, click here.

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. The company’s lead program, Annamycin, is designed to treat relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases, aiming to overcome multidrug resistance and avoid cardiotoxicity common with current anthracyclines.

Average Trading Volume: 3,696,040

Technical Sentiment Signal: Sell

Current Market Cap: $9.37M

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

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