MBRX news

Moleculin completes dosing in Phase 2/3 MIRACLE trial evaluating Annamycin. The company is on track to report comprehensive Part A data in Q1 2027, which is expected to support dose selection for Part B.

Moleculin Biotech announced it has finalized enrollment in the Part A of its Phase 2/3 MIRACLE trial for Annamycin. This achievement positions the company to report pivotal efficacy data on the treatment for relapsed or refractory acute myeloid leukemia in Q1 2027.

Moleculin announced a peer-reviewed study showing no cardiotoxicity with Annamycin at cumulative doses exceeding traditional anthracycline limits, potentially validating its continued clinical development.

Preclinical data suggests that Moleculin Biotech's lead candidate Annamycin stimulates antitumor activity via CD8+ T cells in pancreatic cancer, validating a potential immune-based mechanism of action alongside standard cytotoxicity.

The company received a new patent from the Mexican Patent Office for its lung-targeted liposomal Annamycin formulation, bolstering its intellectual property portfolio ahead of a pivotal clinical trial in AML.

Moleculin announced data presentations on Annamycin at three cancer conferences, focusing on its mechanism, organ distribution, and interaction with the immune system in pancreatic tumors.

Moleculin reported positive interim results from its MIRACLE trial, showing Annamycin achieved three-fold higher complete remission rates than the control. Strong efficacy in a difficult patient population supports the company's path toward regulatory approval.

Independent market research found oncologists reported 6 out of 7 likelihood to prescribe Annamycin for relapsed/refractory AML, citing efficacy, safety, and biomarker-agnostic use. Payers also expressed support for the drug as addressing significant unmet medical need in this patient population.

Moleculin presented pooled analysis of 90 patients showing no detectable cardiotoxicity with Annamycin despite cumulative exposure levels far exceeding conventional anthracycline limits, with independent Cleveland Clinic validation. The positive cardiac safety data support the company's MIRACLE Phas…

Moleculin Biotech announced that pooled cardiac safety data for its lead drug candidate Annamycin has been accepted for poster presentation at the 2026 ASCO Annual Meeting, showing no statistically significant cardiotoxicity at high cumulative doses. The findings support the potential for Annamycin …