Hamlet BioPharma Receives European Approval for Bladder Cancer Phase III Study
Hamlet BioPharma has received regulatory approval from the European Medicines Agency (EMA) for a Phase III clinical study of Alpha1H in bladder cancer. This approval signifies a key milestone for the drug's development in Europe.
Lund, Sweden – Hamlet BioPharma announced on June 29, 2026, that it has secured regulatory approval from the European Medicines Agency (EMA) to proceed with a Phase III clinical study for its drug candidate Alpha1H, intended for the treatment of bladder cancer.
This approval marks a significant milestone in the clinical development of Alpha1H, establishing a clear regulatory pathway towards a potential future marketing application in Europe. The company highlighted the constructive and efficient review process undertaken by the regulatory authorities.
The European Phase III study will be conducted in partnership with a research group led by Professor Marek Babjuk at the Second Faculty of Medicine, Charles University in Prague. This same team recently completed a successful Phase II study of Alpha1H, which demonstrated promising anti-tumor activity and a favorable safety profile in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC).
With this approval, patients diagnosed with low- to intermediate-risk NMIBC will gain access to Alpha1H treatment within the framework of the clinical study. Hamlet BioPharma specializes in developing novel treatments for cancer and infectious diseases.