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Moleculin Nears First Unblinding in Pivotal MIRACLE Trial

Story Highlights
  • Moleculin is nearing first unblinding of its MIRACLE AML trial, comparing Annamycin plus cytarabine to cytarabine alone.
  • Blinded data show markedly higher remission rates and no cardiotoxicity so far, suggesting Annamycin could significantly improve AML outcomes.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Moleculin Nears First Unblinding in Pivotal MIRACLE Trial

Meet Samuel – Your Personal Investing Prophet

Moleculin Biotech ( (MBRX) ) has provided an update.

On May 13, 2026, Moleculin Biotech reported that it is nearing the first unblinding of data from its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia, with the initial 45-patient unblinding expected before June 30, 2026. The adaptive, global, randomized study compares two dosing arms of Annamycin plus cytarabine to cytarabine with placebo, and is enrolling second-line AML patients, including those previously treated with Venetoclax.

The company said blinded efficacy data from the first 45 subjects show a composite complete remission rate above 40% and a complete remission rate near 30%, markedly higher than the roughly 17–18% historical complete remission rates seen with cytarabine alone in similar populations. With 56 of the planned 90 Part A subjects already recruited as of May 1 and no cardiotoxicity reported so far, Moleculin is signaling that Annamycin could represent a significant advance over standard cytarabine regimens for this high-unmet-need AML group and help support its push toward potential regulatory approval.

The most recent analyst rating on (MBRX) stock is a Buy with a $22.00 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 held back primarily by weak financial performance (no revenue, sustained losses, and continued cash burn with financing dependence). Offsetting factors include multiple positive corporate developments around Annamycin (trial progress/safety and strengthened patent coverage), while technicals are broadly neutral and valuation signals are hard to rely on given the pre-revenue profile.

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 developing therapeutics for hard-to-treat tumors and viruses, with a lead program centered on Annamycin, an anthracycline designed to avoid multidrug resistance and cardiotoxicity. Annamycin is being developed for relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases, alongside additional oncology and antiviral candidates including WP1066 and WP1122 in its broader pipeline.

Average Trading Volume: 175,330

Technical Sentiment Signal: Sell

Current Market Cap: $12.49M

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

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