Welcome to our dedicated page for Moleculin Biotec news (Ticker: MBRX), a resource for investors and traders seeking the latest updates and insights on Moleculin Biotec stock.
Moleculin Biotech, Inc. (Nasdaq: MBRX) is a Phase 3 clinical stage pharmaceutical company whose news flow is driven by developments in its oncology and virology pipeline. The company regularly issues updates on its lead anthracycline program Annamycin (naxtarubicin), its Immune/Transcription Modulator WP1066, and its antimetabolite portfolio, including WP1122.
News about Moleculin often focuses on clinical trial milestones, particularly for the pivotal, adaptive design Phase 2B/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia (AML). Investors can follow announcements on enrollment progress, interim unblinding plans, trial expansion across multiple countries, and independent assessments of Annamycin’s cardiotoxicity profile. The company has highlighted an independent expert review of 90 Annamycin-treated subjects across five trials with no evidence of cardiotoxicity based on ECG, echocardiography and cardiac biomarkers.
Another key news theme is pipeline expansion. Moleculin reports investigator-initiated and grant-funded research that extends Annamycin into pancreatic cancer and glioblastoma multiforme (GBM), including collaborations with UNC-Chapel Hill and CIC biomaGUNE. Updates also cover externally funded clinical activity for WP1066 in adult GBM at Northwestern University and pediatric brain tumors at Emory University, along with published Phase 1 data showing STAT3 suppression and anti-tumor immune responses in children.
Moleculin’s news stream also includes corporate and regulatory updates such as reverse stock split actions, Nasdaq listing compliance developments, warrant exercises and patent grants, including an Australian patent for preliposomal Annamycin lyophilizate. For investors tracking MBRX, this news page provides a centralized view of scientific, clinical, regulatory and capital markets announcements related to the company’s efforts in hard-to-treat cancers and certain viral infections.
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.
Moleculin (Nasdaq: MBRX) released a new CEO Corner segment featuring CEO Walter Klemp discussing progress in the pivotal MIRACLE adaptive Phase 3 study of Annamycin plus cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia.
The trial was designed with input from the U.S. FDA and begins with an initial cohort of 45 patients; after treatment of these patients an interim unblinding will assess safety and efficacy to inform the regulatory path. Enrollment and dosing are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The program builds on earlier MB-106 results where AnnAraC reportedly exceeded historical overall survival benchmarks.
Moleculin (Nasdaq: MBRX) announced agreements for immediate exercise of outstanding warrants to purchase up to 2,122,652 shares at an exercise price of $3.90 per share, producing approximately $8.3 million gross proceeds before fees.
The company will issue new unregistered warrants exercisable for up to 6,367,956 shares, subject to shareholder approval, with a five-year term from approval. The transaction is expected to close on or about February 20, 2026, and net proceeds will be used for working capital and general corporate purposes.
Moleculin (Nasdaq: MBRX) reported a preliminary blinded CRc rate of 40% (CR 30%, CRh 10%) in the first 30 subjects of the Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine for R/R AML.
The company has treated 35 subjects, targets unblinding after 45 subjects in Q1 2026, and expects first-arm unblinding in late Q2 2026; safety data to date show absence of cardiotoxicity.
Moleculin (Nasdaq: MBRX) announced a Japan Patent Office notice of allowance for Patent Application No. 2021-577862 covering methods to reconstitute liposomal Annamycin for intravenous use. A patent is expected to issue in the coming months.
The allowed claims focus on controlled-temperature reconstitution to ensure dosing consistency, stability, and handling. This allowance complements U.S. and European patent coverage and supports ongoing Phase 3 development for relapsed or refractory acute myeloid leukemia. Annamycin holds multiple orphan and Fast Track designations.