Moleculin Biotech advances Annamycin AML Phase 3 program

Moleculin Biotech ( (MBRX) ) just unveiled an update.

On January 12, 2026, Moleculin Biotech outlined an accelerated development and clinical outlook centered on its lead drug Annamycin and its STAT3 inhibitor WP1066, highlighting a pivotal global Phase 3 AML trial, new indications, and multiple externally funded studies. The company reported that its MIRACLE Phase 3 trial of Annamycin in combination with cytarabine for relapsed or refractory AML has expanded to nine countries with more than 46 sites selected, remains on track to treat the 45th subject and undergo its first unblinding in the first quarter of 2026, and is expected to reach 90 subjects and a second unblinding by the third quarter of 2026, with Part B initiation in the second half of 2026 and primary efficacy data targeted for 2028. Management emphasized Annamycin’s potential to be the first non-cardiotoxic anthracycline, citing an upcoming Q1 2026 review of cardiotoxicity data and positioning the candidate for a large commercial opportunity given the widespread use and cardiac risks of current anthracyclines. Moleculin also detailed plans for an Atlantic Health–funded investigator-initiated trial of Annamycin in third-line pancreatic cancer expected to start in 2026 and future expansion into third-line and pediatric AML, while projecting a rolling new drug application submission for MIRACLE in 2028. For WP1066, the company highlighted ongoing and planned investigator-initiated programs, including an externally funded Phase 2 trial in glioblastoma at Northwestern University and pediatric brain tumor work at Emory University, with additional preclinical efforts on an intravenous formulation aimed at advancing the drug against brain cancers and potentially overcoming the long-standing challenge of directly targeting STAT3.

The most recent analyst rating on (MBRX) stock is a Hold with a $4.00 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.

The score is weighed down primarily by weak financial fundamentals (no revenue, large losses, sustained cash burn and negative equity) and bearish technicals (below major moving averages with negative MACD). Positive corporate developments around Nasdaq compliance and clinical/pipeline progress provide some offset but are not enough to overcome the current financial and trend risks.

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

More about Moleculin Biotech

Moleculin Biotech, Inc. is a late-stage, Phase 3 clinical-stage pharmaceutical company focused on developing therapeutics for hard-to-treat tumors and viruses. Its lead candidate, Annamycin (naxtarubicin), is a next-generation anthracycline being developed to avoid multidrug resistance and to eliminate the cardiotoxicity associated with traditional anthracyclines, and is currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.

Average Trading Volume: 315,471

Technical Sentiment Signal: Sell

Current Market Cap: $12.66M

For an in-depth examination of MBRX stock, go to TipRanks’ Overview page.