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) 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.
Moleculin Biotech (Nasdaq: MBRX) reported Q2 2025 financial results and significant progress in its clinical trials. The company's flagship Phase 2B/3 MIRACLE trial for Annamycin in treating relapsed/refractory AML is expanding, with 4 active sites and 20+ additional sites expected in Q3 2025. The trial's first data readout is anticipated by end of 2025.
Key developments include positive topline results from the Phase 1B/2 trial for soft tissue sarcoma lung metastases, showing 13.5-month median overall survival. The company reported $7.6 million in cash, sufficient to fund operations into Q4 2025. R&D expenses decreased to $3.6 million from $4.1 million year-over-year, while G&A expenses remained stable at $2.1 million.
[ "Expansion of MIRACLE trial with 4 active sites and 20+ additional sites expected by Q3 2025", "Positive FDA feedback received on pediatric AML study plan", "Encouraging preclinical data for Annamycin against liver cancers", "Strong Phase 1B/2 results showing 13.5-month median overall survival in STS lung mets trial", "New European patent strengthening intellectual property portfolio" ]Moleculin Biotech (NASDAQ:MBRX) has presented promising preclinical data for its lead drug candidate Annamycin in treating various liver cancers. The drug demonstrated significant efficacy against hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases.
Key findings show that Annamycin achieves higher concentrations in the liver, spleen, lungs, and pancreas compared to doxorubicin. The drug exhibited strong anti-tumor activity in multiple cancer models while maintaining a favorable safety profile with low or no cardiotoxicity. Notably, 32 out of 42 subjects previously received above FDA's lifetime maximum allowable anthracycline level without cardiotoxicity evidence.
Annamycin is currently in late-stage clinical development for AML treatment, with preliminary data expected in 2H 2025.
Moleculin Biotech (Nasdaq: MBRX) has received a Notice of Intent to Grant for a European patent application for its drug candidate Annamycin (naxtarubicin). The patent, extending until 2040, covers methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for treating 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, utilizing a unique lipid-based delivery technology with potential applications across various cancer types.