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 clinical-stage pharmaceutical company advancing novel therapies for resistant cancers and viral diseases. This news hub provides investors and researchers with essential updates on clinical developments, regulatory milestones, and scientific breakthroughs.
Access timely announcements about Annamycin's progress through late-stage trials for acute myeloid leukemia (AML), WP1066's immune-modulating potential, and strategic partnerships advancing oncology research. Our curated collection includes press releases on FDA designations, trial protocol updates, and peer-reviewed study publications.
Key coverage areas include non-cardiotoxic anthracycline developments, orphan drug status achievements, and preclinical data on metabolic pathway inhibitors. Bookmark this page for verified updates on Moleculin's innovative approaches to overcoming multidrug resistance in cancer treatment.
Moleculin Biotech (Nasdaq: MBRX) has appointed Adriano Treve as Strategic Advisor for partnerships. Treve brings over 40 years of experience from Roche, with extensive expertise in global healthcare markets and senior executive roles across multiple regions.
The appointment comes at a crucial time as Moleculin approaches key milestones in its Phase 2B/3 MIRACLE trial of Annamycin (naxtarubicin) in combination with cytarabine for acute myeloid leukemia (AML). The company expects the first unblinding of data for 45 patients in H2 2025, followed by a second unblinding in H1 2026.
Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications, including relapsed or refractory AML and soft tissue sarcoma treatment.
Moleculin Biotech (Nasdaq: MBRX) has received approval from Georgia's RAMPA to conduct its Phase 2B/3 MIRACLE clinical trial for Annamycin in combination with cytarabine (AnnAraC) for treating relapsed/refractory acute myeloid leukemia (R/R AML).
The trial has shown early progress with 7 subjects treated and 1 in screening. The company plans to expand to 16 additional clinical sites by August end, building to over 30 sites for Part A. Initial data from the first 45 subjects is expected in 2H 2025.
The MIRACLE study features an adaptive design with Part A randomizing 75-90 subjects across three arms, followed by Part B with approximately 220 additional subjects. Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA.
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