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) 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.
Moleculin (Nasdaq: MBRX) launched CEO Corner on Feb. 13, 2026, a new video and engagement platform featuring CEO Walter Klemp.
The platform aims to provide investors with added perspective on corporate developments, clinical trial progress and strategic initiatives, and accepts questions and topic submissions for future segments.
Moleculin (Nasdaq: MBRX) will present a live video webcast as part of the Webull Financial Corporate Connect Webinar Series on Wednesday, February 11, 2026 at 1:20 PM EST. Walter Klemp, Founder, President, CEO and Chairman, is the scheduled presenter. Registration is available via the company's provided link.
Fab-Form Industries (OTC: FABFF) announced a third-party logistics and fulfillment agreement with All 3 Pools LLC (A3P) to establish a U.S. fulfillment hub in Springfield, Missouri.
Under the Agreement, A3P will provide warehousing, storage and related logistics services at 1861 E. St Louis Street, Springfield, MO 65802, aiming to enable faster delivery times and enhanced customer service for U.S. customers. The company characterized the branch as an operational expansion and said it does not constitute a material acquisition, describing the move as part of ordinary course U.S. distribution growth.
Moleculin (NASDAQ: MBRX) announced on January 13, 2026 that an independent expert reviewed cardiac data for 90 subjects treated with Annamycin and found no evidence of cardiotoxicity. The assessment covers data from five clinical trials in acute myeloid leukemia (AML) and soft tissue sarcoma (STS) across the US and EU, including serial 12-lead ECGs, transthoracic echocardiography with centralized global longitudinal strain (GLS) analysis, and central-lab troponin I/T measurements. The company reported that 65 of 90 subjects exceeded the FDA lifetime anthracycline limit of 550 mg/m2, with one subject exceeding 6500 mg/m2. Moleculin said the results support Annamycin's safety profile and its development as a next-generation anthracycline.
Moleculin (Nasdaq: MBRX) outlined 2026–2028 clinical milestones for its anthracycline Annamycin and STAT3 inhibitor WP1066. The pivotal Phase 2B/3 MIRACLE trial for relapsed/refractory AML has expanded to nine countries with >46 sites selected and ~20 sites contracted, and is on track to treat the 45th Part A subject in Q1 2026 with an unblinding shortly thereafter and a second unblinding in Q3 2026. Part A targets 90 subjects; Part B will add 222 subjects. Institutional/externally funded trials include a 2026 Atlantic Health pancreatic trial and investigator‑initiated WP1066 trials at Northwestern and Emory. Primary MIRACLE efficacy data and a rolling NDA are targeted in 2028.
Moleculin (Nasdaq: MBRX) announced positive Phase 1 results for WP1066 in pediatric recurrent malignant brain tumors on Dec 17, 2025. The Emory physician‑sponsored trial at Aflac/Children’s Healthcare of Atlanta treated 10 children (plus 3 compassionate‑use cases) to identify a maximum feasible dose given twice daily for 14 days.
Key findings: no significant toxicity, determination of a maximum feasible dose, suppression of STAT3 with demonstrable anti‑tumor immune responses, and a partial response in a diffuse intrinsic pontine glioma (DIPG) patient. Results were published in Journal of Clinical Investigation Insight. Trial identifier: NCT04334863.