European Medicines Agency (EMA) Grants Orphan Drug Designation for Moleculin’s Treatment of Acute Myeloid Leukemia (AML)

– Next-generation non-cardiotoxic anthracycline Annamycin with notable signs of clinical efficacy in AML in combination with Cytarabine achieves preliminary CRc rate of 60% in 2nd line AML subjects in a European clinical trial – There are approximately 160,000 people with AML worldwide – Annamycin continues to show no signs of cardiotoxicity (N=82 across multiple studies); Lower toxicity profile than traditional intensive therapy – Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway HOUSTON, April 18, 2024 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML.

The release as fetched from its publisher. moleculin.com ↗