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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) priced a best-efforts public offering of approximately $9.3 million, consisting of 12,376,667 shares of common stock (or pre-funded warrants in lieu) and common warrants to purchase up to 37,130,001 shares at a combined public offering price of $0.75 per share and associated warrants.
The common warrants are immediately exercisable at $0.75 per share and expire five years after initial exercise. Closing is expected on or about August 3, 2026, subject to customary conditions. According to Moleculin, net proceeds will be used to advance its drug candidate Annamycin through clinical development and for working capital. The securities are offered under an effective Form S-1 registration statement.
Moleculin (Nasdaq: MBRX) reported updated preliminary blinded data from Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in relapsed/refractory AML. Among 62 evaluable subjects, blinded complete remission (CR) was 24% and composite CR (CRc) was 37% after a single treatment cycle.
Of these, 30 patients had failed prior first-line venetoclax-based therapy, with blinded CR and CRc of 23% and 37%, respectively. According to Moleculin, this compares with published salvage CRc of about 13% and median survival of 2.4 months after venetoclax failure, though this is not a controlled comparison. Enrollment has reached 74 of 90 subjects, with final Part A treatment expected in September 2026 and comprehensive unblinded Part A results anticipated between December 2026 and February 2027. Across three blinded looks, CRc has remained near 37–40%, and the company reports no evidence of cardiotoxicity to date.
Moleculin (Nasdaq: MBRX)/b) announced that CEO Walter Klemp joined a Virtual Investor “What This Means” segment to discuss from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial of Annamycin in R/R AML.
He reviews early efficacy trends across both treatment arms, summarizes key data, and discusses Annamycin’s commercial opportunity and potential addressable market if approved. The segment is available for on-demand viewing.
Moleculin (Nasdaq: MBRX) reported positive interim Phase 2/3 MIRACLE results for L-Annamycin in relapsed or refractory AML. In the first 45 patients, complete remission (CR) rates were 43% and 36% for the Annamycin arms versus 12% for control; composite CR (CRc) reached 50% and 57% versus 29% for control, all after a single treatment cycle.
The independent data monitoring committee saw a strong numeric efficacy trend favoring Annamycin, recommended continuing the trial without dropping any dose, and noted statistical significance was not expected at this first interim look. Part A enrollment has reached 67 of 90 planned patients, with Part B intended to use the selected dose in the pivotal analysis.
Moleculin Biotech (Nasdaq: MBRX) reported independent market research on Annamycin in relapsed/refractory AML. Hematologist-oncologists indicated an average likelihood-to-prescribe of 6 out of 7, citing reported deep complete and MRD-negative remissions, transplant-bridging potential, biomarker-agnostic use, and reduced cardiotoxicity.
Pediatric specialists highlighted reduced cardiotoxicity for long-term survivors, while payers viewed Annamycin’s efficacy, safety profile and broad applicability as a potentially compelling value proposition in a setting with significant unmet need, especially after venetoclax-based therapy or without actionable mutations.
Moleculin (Nasdaq: MBRX) announced that CEO Walter Klemp appeared in a Virtual Investor “What This Means” segment.
He discussed reaching enrollment of the 45th subject in the pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in adult R/R AML, and preparations for interim data unblinding targeted for mid-2026.
Moleculin (Nasdaq: MBRX) reported pooled ASCO 2026 data on lead candidate Annamycin, showing no detectable cardiotoxicity across five completed trials in AML and soft tissue sarcoma.
In 90 treated patients (78 with paired LVEF), high cumulative doses up to 2,970 mg/m² showed no significant LVEF change and no dose–response or age-related cardiotoxicity, based on independent Cleveland Clinic review. Previously reported AML combination data showed 50% CR, 60% CRc, median OS 12.39 months and 50% of responders proceeding to transplant. Moleculin’s pivotal MIRACLE Phase 2b/3 AnnAraC trial in relapsed/refractory AML is ongoing, with unblinding of the first 45 patients expected in June 2026.
Moleculin (Nasdaq: MBRX) announced that pooled cardiac safety data for its lead anthracycline candidate Annamycin were accepted for poster presentation at the 2026 ASCO Annual Meeting on May 30, 2026.
The analysis of 90 patients across five trials showed no statistically significant change in LVEF, no correlation between cumulative dose or age and LVEF change, and no evidence of drug-induced cardiotoxicity on independent review. These findings, together with earlier Phase 1b/2 AML data (50% CR, 60% CRc, median OS 12.39 months), are described as supporting the rationale for the ongoing pivotal Phase 2b/3 MIRACLE trial in AML.
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.