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 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.