08:46 AM EDT, 06/05/2025 (MT Newswires) -- Tempest Therapeutics ( TPST ) said Thursday the European Medicines Agency, or EMA, has granted orphan drug designation to its experimental drug amezalpat for the potential treatment of hepatocellular carcinoma.

This designation provides certain benefits, including potential market exclusivity for 10 years after approval, a reduction in regulatory fees and a centralized European Union approval process, the company said.

Amezalpat also received orphan drug designation and fast track designation from the US Food and Drug Administration earlier this year.

Tempest said the designations followed phase 1/2 data showing amezalpat combined with standard-of-care achieved a six-month improvement in median overall survival and a hazard ratio of 0.65 compared with standard treatment alone.

Hepatocellular carcinoma is an aggressive cancer mostly caused by chronic liver disease, the company said.

Shares of the company were up more than 1% in recent premarket activity.