Moleculin Biotech Increases Enrollment to 78% for MIRACLE Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 09 2025
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Source: Newsfilter
- Enrollment Progress: Moleculin's MIRACLE trial enrollment has increased to 78%, up from 60% in November, with expectations to complete treatment of the first 45 subjects by Q1 2026, thereby laying the groundwork for data unblinding.
- Clinical Activity Tracking: The company reports that blinded clinical activity remains within expected ranges, indicating positive responses from investigators, particularly as recruitment improves in the US and Europe.
- Trial Design Advantages: The MIRACLE trial is a global, multi-center, randomized, double-blind, placebo-controlled adaptive design, with the first unblinding set to provide preliminary efficacy data for 45 subjects, potentially offering strong support for Annamycin's approval.
- Market Potential: Annamycin, as a next-generation anticancer drug, has received FDA Fast Track and Orphan Drug Designations, expected to fill a significant gap in acute myeloid leukemia treatment, presenting substantial market opportunities.
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Analyst Views on MBRX
Wall Street analysts forecast MBRX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MBRX is 24.33 USD with a low forecast of 20.00 USD and a high forecast of 31.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.280
Low
20.00
Averages
24.33
High
31.00
Current: 4.280
Low
20.00
Averages
24.33
High
31.00
About MBRX
Moleculin Biotech, Inc. is a Phase III clinical-stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing tumors and viruses. The Company is conducting a pivotal Phase III trial evaluating Annamycin, a non-cardiotoxic anthracycline, in combination with Cytarabine for the treatment of subjects with relapsed/refractory acute myeloid leukemia (AML). It has three core technologies and six drug candidates, three of which have shown human activity in clinical trials. Its core technologies consist of Annamycin, WP1066 Portfolio, and WP1122 Portfolio. Annamycin is designed to avoid multidrug resistance mechanisms and cardiotoxicity. Its WP1066, is an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other transcription factors, and its portfolio includes WP1193, and WP1220. Its WP1122 contains compounds including WP1096, and WP1097, which is designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Moleculin Biotech's 2026 MIRACLE Trial Data Unblinding Expected
- Clinical Trial Progress: Moleculin expects to complete the unblinding of data for 45 subjects in the MIRACLE trial in Q1 2026, which is anticipated to provide critical efficacy data for treating acute myeloid leukemia (AML), thereby enhancing Annamycin's market recognition.
- New Indication Expansion: Annamycin is set to initiate a clinical trial for pancreatic cancer in 2026, funded by Atlantic Health, based on preclinical data showing unexpected activity in pancreatic cancer models, further enhancing its market potential.
- Global Trial Network: The MIRACLE trial has expanded to nine countries, including the US and several European nations, with 46 trial sites selected, and is expected to recruit the 90th subject by Q1 2026, demonstrating the company's strong execution capabilities on a global scale.
- Significant Market Opportunity: Annamycin is poised to become the world's first non-cardiotoxic anthracycline, and given that nearly half of cancer patients currently use cardiotoxic drugs, the market demand potential is enormous, likely attracting increased investor interest.
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Moleculin Stock Falls 17% Despite Encouraging Phase 1 WP1066 Results for Pediatric Brain Tumors
Stock Performance: Moleculin Biotech, Inc. (MBRX) shares fell 16.84% to $3.90 despite reporting positive results from a Phase 1 clinical trial of WP1066 for children with recurrent malignant brain tumors.
Clinical Trial Results: The trial indicated that the treatment was safe, induced anti-tumor immune responses, and suppressed STAT3 activity, showing promising signs in a challenging pediatric cancer context.
Market Reaction: Following the announcement, the stock experienced significant volatility and a steep sell-off, with trading activity exceeding average levels as investors reassessed the company's near-term risks.
Trading Range: MBRX's stock trades within a 52-week range of approximately $3.63 to $91.25, highlighting its volatility in the biotech market.
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