Tempest Therapeutics Inc., a clinical-stage biotechnology company, has announced that the European Medicines Agency $(EMA)$ has granted Orphan Drug Designation to their oral therapy, amezalpat (TPST-1120), for the treatment of patients with hepatocellular carcinoma $(HCC)$. This designation builds on the earlier U.S. Food & Drug Administration (FDA) Orphan Drug Designation and Fast Track Designation, highlighting the urgent need for new treatment options in liver cancer. The regulatory support comes after strong positive outcomes from a global Phase 1b/2 study, which demonstrated superior results for amezalpat combination therapy compared to standard care. Tempest CEO Stephen Brady emphasized the significant unmet need in HCC treatment and expressed confidence in amezalpat's potential impact on patients and families affected by this disease.