Moleculin Biotech to Advance Annamycin Pivotal Trials in 2026
Moleculin Biotech provided a business outlook and outlined expected upcoming milestones for its next generation non-cardiotoxic anthracycline Annamycin and its STAT3 inhibitor WP1066. "Annamycin is set for a number of milestones in 2026 including two data readouts in its pivotal Phase 2B/3 MIRACLE trial treating second line acute myeloid leukemia plus embarking in its first clinical trial for the treatment of pancreatic cancer," commented Walter Klemp, Chairman and CEO of Moleculin. "The two MIRACLE data readouts will set the course for the pivotal trial in two ways - potentially demonstrating the efficacy of the Annamycin arms versus the control arm and setting the dose for the Annamycin arm to be used in Part B of the MIRACLE trial... Importantly, we believe Annamycin has the potential to become the world's first ever non-cardiotoxic anthracycline and we are expecting more data supporting its lack of cardiotoxicity to be presented early this year. Considering that nearly half of all cancers and 60% of all childhood cancers are currently treated with cardiotoxic anthracyclines that are known to result in permanent heart damage, we think that makes the market opportunity for Annamycin potentially enormous." The company is advancing the development of Annamycin in combination with cytarabine with a Phase 3 pivotal trial for the treatment of AML subjects who are refractory to or relapsed after first line induction therapy. This Phase 3 "MIRACLE" trial is global, including sites in the US, the European Union and Eastern Europe. The trial has expanded to nine countries - the US, Spain, Italy, Poland, Czechia, Romania, Ukraine, Lithuania and Georgia with over 46 sites selected, about 20 sites contracted with more coming online weekly. The company is on track to treat the 45th subject in Part A of the MIRACLE trial in the first quarter of 2026.
Trade with 70% Backtested Accuracy
Analyst Views on MBRX
About MBRX
About the author
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.
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.
Moleculin's WP1066 Demonstrates Immune Response and Positive Safety Profile in Pediatric Brain Cancer Study
Positive Clinical Trial Results: Moleculin Biotech's Phase 1 trial of WP1066 in children with recurrent malignant brain tumors showed anti-tumor immune activity and a favorable safety profile, with one patient achieving a partial tumor response.
Targeting Aggressive Cancers: The trial focused on aggressive pediatric brain cancers like diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG), which have poor survival rates and limited treatment options.
Mechanism of Action: WP1066 is designed to inhibit oncogenic transcription factors and stimulate immune responses against tumors, addressing critical drivers of cancer cell survival and inflammation.
Future Research Plans: Following the promising results, a Phase 2 study is being planned to further evaluate the efficacy and long-term outcomes of WP1066 in pediatric patients.
Moleculin Biotech Increases Enrollment to 78% for MIRACLE Trial
- Enrollment Progress: Moleculin's MIRACLE trial has achieved 78% enrollment of its target subjects, up from 60% in November, with expectations to complete treatment of the first 45 subjects by Q1 2026, laying the groundwork for data unblinding.
- Clinical Activity Tracking: The company reports that blinded clinical activity is tracking within expected ranges, indicating strong enthusiasm from investigators in the US and Europe, particularly as recruitment challenges improve, reflecting a robust market demand for new therapies.
- Trial Design: The MIRACLE trial is a global multi-center, randomized, double-blind, placebo-controlled adaptive design, with plans for preliminary data unblinding at 45 subjects, which could provide strong support for Annamycin's approval if results are favorable.
- Future Outlook: Moleculin anticipates completing recruitment and treatment of 90 subjects in the first half of 2026, further advancing Annamycin's application in acute myeloid leukemia treatment and addressing a significant market gap.
Moleculin Biotech Increases Enrollment to 78% for MIRACLE Trial
- 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.
Moleculin Biotech to Showcase Company Overview in Virtual Investor Closing Bell Series
Company Participation: Moleculin Biotech Inc. will participate in the Virtual Investor Closing Bell Series on December 2, 2025, where CEO Walter Klemp will present a corporate overview and engage in a live Q&A session with investors.
Lead Program Overview: The company's lead program, Annamycin, is a next-generation anthracycline currently in a pivotal Phase 3 trial for relapsed or refractory acute myeloid leukemia and is also being developed for advanced soft tissue sarcoma.
Pipeline Development: Moleculin is advancing several candidates, including WP1066 for glioblastoma and pancreatic cancer, WP1122 for pathogenic viruses and certain cancers, and WP1220 for cutaneous T-cell lymphoma.
Stock Performance: As of the latest update, MBRX shares are trading at $0.27, down 1.78%, with a trading range over the past year between $0.25 and $3.65.
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.
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.
Moleculin's WP1066 Demonstrates Immune Response and Positive Safety Profile in Pediatric Brain Cancer Study
Positive Clinical Trial Results: Moleculin Biotech's Phase 1 trial of WP1066 in children with recurrent malignant brain tumors showed anti-tumor immune activity and a favorable safety profile, with one patient achieving a partial tumor response.
Targeting Aggressive Cancers: The trial focused on aggressive pediatric brain cancers like diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG), which have poor survival rates and limited treatment options.
Mechanism of Action: WP1066 is designed to inhibit oncogenic transcription factors and stimulate immune responses against tumors, addressing critical drivers of cancer cell survival and inflammation.
Future Research Plans: Following the promising results, a Phase 2 study is being planned to further evaluate the efficacy and long-term outcomes of WP1066 in pediatric patients.
Moleculin Biotech Increases Enrollment to 78% for MIRACLE Trial
- Enrollment Progress: Moleculin's MIRACLE trial has achieved 78% enrollment of its target subjects, up from 60% in November, with expectations to complete treatment of the first 45 subjects by Q1 2026, laying the groundwork for data unblinding.
- Clinical Activity Tracking: The company reports that blinded clinical activity is tracking within expected ranges, indicating strong enthusiasm from investigators in the US and Europe, particularly as recruitment challenges improve, reflecting a robust market demand for new therapies.
- Trial Design: The MIRACLE trial is a global multi-center, randomized, double-blind, placebo-controlled adaptive design, with plans for preliminary data unblinding at 45 subjects, which could provide strong support for Annamycin's approval if results are favorable.
- Future Outlook: Moleculin anticipates completing recruitment and treatment of 90 subjects in the first half of 2026, further advancing Annamycin's application in acute myeloid leukemia treatment and addressing a significant market gap.
Moleculin Biotech Increases Enrollment to 78% for MIRACLE Trial
- 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.
Moleculin Biotech to Showcase Company Overview in Virtual Investor Closing Bell Series
Company Participation: Moleculin Biotech Inc. will participate in the Virtual Investor Closing Bell Series on December 2, 2025, where CEO Walter Klemp will present a corporate overview and engage in a live Q&A session with investors.
Lead Program Overview: The company's lead program, Annamycin, is a next-generation anthracycline currently in a pivotal Phase 3 trial for relapsed or refractory acute myeloid leukemia and is also being developed for advanced soft tissue sarcoma.
Pipeline Development: Moleculin is advancing several candidates, including WP1066 for glioblastoma and pancreatic cancer, WP1122 for pathogenic viruses and certain cancers, and WP1220 for cutaneous T-cell lymphoma.
Stock Performance: As of the latest update, MBRX shares are trading at $0.27, down 1.78%, with a trading range over the past year between $0.25 and $3.65.
