Tempest Therapeutics receives ODD from FDA for TPST-1120

Tempest Therapeutics (TPST) announced that the U.S. Food and Drug Administration, FDA, 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. “Receiving orphan drug designation for amezalpat to treat HCC underscores the critical need for new treatment options for patients suffering from this historically hard to treat disease,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Tempest is dedicated to developing groundbreaking cancer treatments that will improve patients’ lives, and with broad agreement in hand from both the FDA and EMA, the team continues to prepare for a pivotal phase 3 study for amezalpat in first-line HCC patients.”