Tempest receives orphan drug designation from the european medicines agency for amezalpat for the treatment of patients with hcc

Ema orphan drug designation (odd) builds on u.s. food & drug administration (fda) odd and fast track designation, underscoring the urgent need for new treatment options the multiple regulatory designations were granted following strong positive results from a global randomized phase 1b/2 study in first-line hcc demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to standard of care alone brisbane, calif., june 05, 2025 (globe newswire) -- tempest therapeutics, inc. (nasdaq: tpst), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the european medicines agency (ema) has granted orphan drug designation (odd) to amezalpat (tpst-1120), an oral, small molecule, selective ppar⍺ antagonist for the treatment of patients with hepatocellular carcinoma (hcc).
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