Tempest Therapeutics announces FDA granted ODD to TPST-1495

Tempest Therapeutics (TPST) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation, ODD, to TPST-1495, the company’s novel dual receptor inhibitor of prostaglandin signaling, for the treatment of patients with Familial Adenomatous Polyposis. “Receiving orphan drug designation for TPST-1495, our second clinical program, is a significant milestone in our mission to bring innovative therapies to patients with unmet medical need,” said Stephen Brady, President and CEO of Tempest. “This designation for the treatment of FAP underscores Tempest’s mission to make a meaningful difference in the lives of patients and builds on the momentum from prior designations received for amezalpat in hepatocellular carcinoma.”