Tempest Achieves Significant Milestones in Cancer Treatment Development

August 11, 2025 - 19:09

Tempest has made notable progress in its oncology pipeline, receiving clearance to initiate a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China. This advancement marks a critical step in the quest to provide effective treatment options for patients battling this aggressive form of liver cancer.

In addition to the trial clearance in China, the company has been granted orphan drug designation by the European Medicines Agency (EMA) for amezalpat, further highlighting the therapy's potential in addressing unmet medical needs for HCC patients. This designation is crucial as it provides various incentives to expedite the development and review of the drug.

At the recent 2025 AACR Annual Meeting, Tempest presented new data on the mechanism of action of amezalpat, reinforcing its promise as a novel cancer treatment. Furthermore, the FDA has granted orphan drug designation for TPST-1495, aimed at treating familial adenomatous polyposis, showcasing the company's commitment to advancing therapies for rare diseases.