Tempest Therapeutics (TPST) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to amezalpat, an oral, small molecule, selective PPAR antagonist for the treatment of patients with hepatocellular carcinoma. “We are thrilled to receive Fast Track designation from the FDA,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. “This designation, following the Orphan Drug designation granted last month, reinforces the promise of amezalpat as a potential treatment option for patients affected by HCC. We look forward to working closely with the FDA and foreign regulatory agencies to develop amezalpat with the goal of bringing this promising therapy to patients.”
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