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. 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 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.
Moleculin (Nasdaq: MBRX) announced agreements for immediate exercise of existing warrants to purchase an aggregate of 1,044,329 shares of common stock (727,969 shares issued Feb 2025 at $6.63; 316,360 shares issued Aug 2025 at $6.3219).
The aggregate gross proceeds are expected to be approximately $6.5 million before advisory fees. In exchange, the company will issue new unregistered warrants exercisable for up to 2,610,823 shares at $6.63 per share, exercisable upon shareholder approval for a term of five years. Transaction expected to close on or about Dec 11, 2025, subject to customary closing conditions. Roth Capital Partners and Maxim Group are financial advisors.
Moleculin (Nasdaq: MBRX) reported that 78% of the target subjects for the first planned interim unblinding of its pivotal Phase 2B/3 MIRACLE trial have consented, up from 60% in November, with consented subjects now across seven countries. The company expects to complete treatment of the first 45 subjects in Q1 2026 and to finish Part A (up to 90 patients) in the first half of 2026. Annamycin (naxtarubicin) holds FDA Fast Track and Orphan Drug designations and composition-of-matter patent protection through 2040 (potential extension to 2045). Enrollment and blinded activity are reported as within expected ranges.