Hamlet Biopharma has received regulatory approval in Europe for a phase 3 study with the drug candidate Alpha1H for the treatment of non-muscle-invasive bladder cancer.The approval from the European Medicines Agency EMA means, according to the company, an important milestone in the development program and provides a clear regulatory path toward a future application for market approval in Europe.The study will be conducted in collaboration with professor Marek Babjuk's research group at Charles University in Prague. The same group previously conducted a phase 2 study in which Alpha1H showed promising tumor-inhibiting effect and a favorable safety profile.The company states that patient recruitment is expected to begin without delay.