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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) announced a grant-funded research and material transfer agreement with the University of North Carolina at Chapel Hill dated Nov 12, 2025 to support investigator-initiated preclinical studies evaluating Annamycin for pancreatic cancer.
Moleculin will supply Annamycin while UNC investigators will test liposomal and free formulations versus Doxil and free doxorubicin in PDAC GEMM models to assess tumor delivery when combined with novel agents and modalities. The company noted Annamycin's regulatory designations and its ongoing pivotal Phase 2B/3 MIRACLE trial (NCT06788756) in relapsed/refractory AML.
Moleculin (Nasdaq: MBRX) will present at the 14th Annual Acute Leukemia Meeting in Madrid on October 30-31, 2025. Dr. Paul Waymack, senior chief medical officer, will speak on Thursday, October 30 at 2:35 PM CEST about L-Annamycin (naxtarubicin) and the ongoing pivotal Phase 2B/3 “MIRACLE” trial.
The MIRACLE study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design trial evaluating Annamycin combined with cytarabine (AnnAraC) in adult patients with relapsed or refractory acute myeloid leukemia (R/R AML). It is a global approval trial with sites in the US, Europe and the Middle East (clinicaltrials.gov NCT06788756; euclinicaltrials.eu 2024-518359-47-00). Annamycin currently holds FDA Fast Track status and Orphan Drug designations from FDA and EMA for R/R AML.
Moleculin (Nasdaq: MBRX) announced that IP Australia granted Patent No. 2024203598 titled "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE", covering preliposomal Annamycin lyophilizates with improved stability and high purity.
The patent has a base term currently extending until June 2040, subject to extension to account for regulatory approval time, and expands the company's global IP portfolio alongside an expected Canadian patent and previously issued U.S. and allowed European patents. Annamycin (naxtarubicin) has FDA Fast Track Status and Orphan Drug Designation for relapsed/refractory AML and Orphan Drug Designation for STS lung mets; EMA orphan status for relapsed/refractory AML is also noted.
Moleculin (NASDAQ:MBRX) is collaborating with Atlantic Health on an investigator-initiated Phase 1B/2 single-arm study testing Annamycin for third-line (3L) advanced pancreatic cancer, announced Oct 23, 2025. Moleculin will supply drug material and maintain the IND; Atlantic Health will conduct and fund the study. Moleculin estimates incremental trial costs of approximately $1 million from 2026 into 2030 for drug supply and outside lab testing. Preclinical data show pancreatic uptake, activity vs pancreatic tumors and liver metastases, and topoisomerase II as a validated target. Annamycin has FDA Fast Track and multiple Orphan Drug designations.
Moleculin Biotech (Nasdaq: MBRX) has received a notice of allowance from the Canadian Intellectual Property Office for a patent covering their novel drug candidate Annamycin. The patent, extending until June 2040, will protect methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for approval, targeting acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.
Moleculin Biotech (Nasdaq: MBRX) reported significant progress in its Phase 3 "MIRACLE" clinical trial for Annamycin in combination with cytarabine (AnnAraC) for treating acute myeloid leukemia (AML). The company has recruited 13 subjects (10 already dosed) and expects to reach 20 subjects by September 2025.
The trial is expanding globally across multiple European countries and the US, with plans to increase from 12 to 20 active sites in September, and over 30 sites by year-end. The company aims to recruit the 45th subject in Q4 2025 for initial data unblinding, with Part A completion expected in H1 2026.
The MIRACLE study employs an adaptive design with 75-90 subjects in Part A and approximately 220 additional subjects in Part B. Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA.
Moleculin Biotech (Nasdaq: MBRX) has reached a significant milestone in its Phase 2B/3 MIRACLE trial by dosing the first EU patient for its AnnAraC treatment targeting relapsed/refractory acute myeloid leukemia (R/R AML). The trial has active recruitment sites in the US, Spain, Ukraine, Georgia, and Romania.
The adaptive design study will evaluate AnnAraC (Annamycin combined with cytarabine) across 75-90 subjects in Part A, with an initial data unblinding planned for the first 45 subjects in 2H 2025. Part B will involve approximately 220 additional subjects. The company expects to complete the second unblinding in 1H 2026.
Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications, highlighting its potential significance in treating hard-to-treat cancers.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for tumors and viruses, has secured $6.0 million in gross proceeds through warrant exercises. The company entered into agreements with existing warrant holders for the immediate exercise of warrants to purchase 16,216,216 shares at $0.37 per share.
In exchange for the immediate cash exercise, Moleculin will issue new unregistered warrants for up to 64,864,864 shares at an exercise price of $0.55 per share, exercisable for five years upon shareholder approval. The transaction is expected to close on August 28, 2025. The company plans to use the proceeds for working capital and general corporate purposes.
Moleculin Biotech (Nasdaq: MBRX) has announced significant positive survival data from its Phase 1B/2 (MB-106) clinical trial of Annamycin combined with Cytarabine (AnnAraC) for acute myeloid leukemia (AML) treatment. The trial demonstrated remarkable median overall survival rates: 15 months for complete remission subjects (n=8), 12 months for 2nd line patients (n=9), and 9 months for the intent-to-treat population (n=22).
Key achievements include a 36% complete remission rate in the total population and a 50% CR rate in second-line patients. Notably, 50% of CR patients proceeded to bone marrow transplant. The treatment showed no cardiotoxicity, with median CR durability of 10 months. The company expects database lock by September 2025 and final clinical study report in Q1 2026.
Moleculin continues to advance Part A of its pivotal Phase 3 MIRACLE trial, targeting recruitment of 45 patients by year-end 2025.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, will participate in the upcoming Webull Financial Corporate Connect Webinar Series: Biotech/MedTech. The virtual presentation will be delivered by Walter Klemp, the company's Founder, President, CEO and Chairman, on Wednesday, August 20, 2025 at 2:00 PM ET.