Moleculin Biotech’s Annamycin Trial Approved by EMA

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

On May 12, 2025, Moleculin Biotech announced that the European Medicines Agency approved its Clinical Trial Application for a pivotal Phase 2B/3 trial of Annamycin combined with cytarabine for treating relapsed or refractory acute myeloid leukemia. The trial, known as MIRACLE, will expand to nine additional EU countries, enhancing recruitment potential and positioning Moleculin to meet enrollment and data milestones. The trial aims to address the unmet need for effective treatments in venetoclax regimen failures, with initial data expected in the second half of 2025.

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, avoiding common multidrug resistance and cardiotoxicity issues.

Average Trading Volume: 5,804,132

Technical Sentiment Signal: Sell

Current Market Cap: $14.83M

See more insights into MBRX stock on TipRanks’ Stock Analysis page.