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Moleculin Reports Positive Progress in MIRACLE AML Trial

Story Highlights
  • Moleculin advanced its pivotal MIRACLE AML trial, treating 35 patients by February 10, 2026 and targeting first unblinding after 45 subjects in Q1 2026.
  • Blinded preliminary data showed a 40% composite remission rate that exceeds historical cytarabine outcomes, suggesting Annamycin may significantly improve second-line AML treatment, even in high-risk, venetoclax-failure patients.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Moleculin Reports Positive Progress in MIRACLE AML Trial

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Moleculin Biotech ( (MBRX) ) has issued an announcement.

On February 18, 2026, Moleculin Biotech reported progress in its pivotal global Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in adults with relapsed or refractory acute myeloid leukemia after a single prior induction therapy. As of February 10, 2026, the company had treated 35 subjects, identified or screened 11 more across seven countries and 24 sites, and said it remains on track to reach the first 45 treated subjects in the first quarter of 2026 for an initial data unblinding expected thereafter.

The company disclosed blinded preliminary efficacy data from the first 30 treated subjects, showing a composite complete remission rate of 40%, split between 30% complete remission and 10% complete remission with partial hematologic recovery. Executives and external clinicians highlighted that these blinded rates appear to substantially exceed historical response rates for cytarabine alone, even though roughly one-third of participants are estimated not to have received Annamycin.

Moleculin emphasized that about 35% of patients treated to date had previously failed venetoclax regimens and many carried genetic markers associated with poor prognosis, underscoring the potential significance of the observed responses. Coupled with prior safety data in 90 subjects showing no cardiotoxicity, the company argues that Annamycin could represent a meaningful advance in second-line AML therapy and a catalyst for future partnerships as further unblindings occur through the second half of 2026.

The most recent analyst rating on (MBRX) stock is a Hold with a $4.50 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 down primarily by weak financial performance (pre-revenue losses, ongoing cash burn, and prior negative equity) and bearish technicals (below key moving averages with negative MACD). Positive corporate developments (clinical progress and regained Nasdaq compliance) provide some offset, while valuation is limited by ongoing losses and no dividend.

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 focus on hematologic malignancies. Its flagship candidate, Annamycin (naxtarubicin), is a next-generation, non-cardiotoxic anthracycline in development for relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases, and holds multiple orphan designations and fast track status.

Average Trading Volume: 287,684

Technical Sentiment Signal: Sell

Current Market Cap: $13.36M

For detailed information about MBRX stock, go to TipRanks’ Stock Analysis page.

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