Tempest Therapeutics: European Medicines Agency Grants Orphan Drug Designation To Amezalpat

(RTTNews) - Tempest Therapeutics (TPST) announced that the European Medicines Agency has granted Orphan Drug Designation to amezalpat, an oral, small molecule, selective PPAR antagonist for the treatment of patients with hepatocellular carcinoma. Earlier in the year, the FDA had granted both ODD and Fast Track Designation to amezalpat to treat patients with HCC.

The company said these three designations follow positive data across multiple key study efficacy and safety endpoints from a global, randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC.

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