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Moleculin Biotech, Inc. reports developments as a clinical-stage pharmaceutical company advancing drug candidates for hard-to-treat tumors and viruses. Its lead program is Annamycin, also known as naxtarubicin, a next-generation anthracycline designed to avoid cardiotoxicity and multidrug resistance, with development focused on relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Recurring news covers Annamycin clinical and preclinical data, the MIRACLE study of Annamycin in combination with cytarabine, oncology conference presentations, intellectual-property protection for liposomal Annamycin, and corporate financial updates. Additional pipeline coverage includes WP1066, an immune/transcription modulator targeting p-STAT3 and other oncogenic transcription factors, and WP1122, an antimetabolite program for pathogenic viruses and cancer indications.
Moleculin (Nasdaq: MBRX) reported Q1 2026 results and a clinical update on its pivotal MIRACLE trial in relapsed/refractory AML.
Blinded data show a 40% composite complete remission rate at both the 30- and 45-subject marks. The first interim unblinding is expected in June 2026 after enrolling 45 subjects, with 90 subjects targeted for Q3 2026. Q1 2026 R&D expenses rose to $5.4M from $3.4M, mainly due to MIRACLE Europe trials, while G&A held at $2.5M. The company raised about $8.3M in Q1 financings and ended March 31, 2026 with $10.3M in cash and cash equivalents; management believes this funds operations into Q3 2026. Moleculin also outlined milestones through 2028, including MIRACLE Part B, additional AML studies, and a planned rolling NDA start in 2028.
Moleculin (Nasdaq: MBRX) reported preliminary blinded efficacy from 45 subjects in its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in second-line relapsed/refractory AML.
Blinded data show CRc >40% and CR ~30%, versus historical cytarabine CR ~17–18%. First 45-subject unblinding is expected before June 30, 2026, with 56 of 90 Part A subjects enrolled as of May 1. Annamycin holds FDA Fast Track and multiple Orphan Drug designations and patent protection potentially through 2045.
Moleculin (Nasdaq: MBRX) reported pooled cardiac safety data for Annamycin in relapsed/refractory AML from 5 completed trials (90 patients), published as an abstract at EHA 2026.
An independent Cleveland Clinic review found no clinically significant treatment-related cardiotoxicity, even at anthracycline-equivalent doses above conventional lifetime limits, with stable mean ejection fraction and no observed dose–cardiac function relationship.
Moleculin Biotech (NASDAQ: MBRX) announced issuance of Hong Kong patent No. 40073244 for a method of reconstituting liposomal Annamycin, extending protection through June 25, 2040. The patent is jointly owned with The University of Texas System and complements patents across North America, Europe and Asia ahead of Phase 3 data.
Moleculin (Nasdaq: MBRX) presented AACR 2026 preclinical data showing liposomal Annamycin (L-ANN) produced significant tumor volume reduction in multiple PDAC models (p<0.001) and extended median survival by more than 60% in a metastatic model (29 vs 18 days; p=0.0003).
Pharmacokinetics showed higher pancreatic and tumor accumulation versus doxorubicin (p<0.0001), L-ANN induced CD8+ and CD4+ T-cell infiltration, and no cardiotoxicity was observed, supporting further evaluation alone and with checkpoint or KRAS inhibitors.
Moleculin (Nasdaq: MBRX) announced an abstract on its lead candidate annamycin was accepted for a poster at the 2026 ASCO Annual Meeting, held May 29–June 2, 2026 in Chicago.
The poster, “Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis,” will be presented May 30, 2026, 1:30–4:30 PM CDT at Poster Board #8 in the Symptom Science and Palliative Care session.
Moleculin (Nasdaq: MBRX) released a new CEO Corner segment on April 7, 2026 featuring CEO Walter Klemp discussing Annamycin’s non-cardiotoxic safety profile. The company says Annamycin avoided cardiac damage in preclinical and clinical studies, which could broaden options for relapsed/refractory AML and advanced solid tumor patients.
Mr. Klemp noted potential benefits for physicians, and favorable regulatory and commercial implications as the company advances the MIRACLE Study.
Moleculin (Nasdaq: MBRX) announced enrollment of the 45th subject in its global Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) for relapsed/refractory AML, triggering preparations for an interim unblinding expected mid-2026. Preliminary blinded results among the first 30 patients showed a 40% composite complete remission rate (30% CR; 10% CR with partial recovery), with ~35% having failed prior venetoclax therapy. The protocol calls for early unblinding at 45 subjects and full Part A completion at 90 subjects, supporting dose selection and a potential accelerated approval pathway based on the CR endpoint.
Moleculin (Nasdaq: MBRX) reported full-year 2025 results and a clinical update for Annamycin. The pivotal MIRACLE trial delivered a preliminary blinded CRc of 40% in the first 30 Annamycin-treated subjects (CR 30%, CRh 10%), and an interim unblinding of 45 subjects is on track for mid-2026.
Financially, R&D expense was $15.9M in 2025, cash and equivalents were $8.9M at year-end, and management expects funding into the third quarter of 2026 including $8.3M raised in Q1 2026.
Moleculin (Nasdaq: MBRX) will present at the 38th Annual ROTH Conference in Dana Point, CA, participating in a fireside chat on March 24, 2026, 12:00–12:25 PM PT.
Presenters include Walter Klemp, Founder, President, Chairman & CEO, and Jon Foster, EVP & CFO. Investors may register or arrange one-on-one meetings through ROTH.