Tempest Therapeutics: FDA Grants Orphan Drug Designation To TPST-1495

(RTTNews) - Tempest Therapeutics (TPST) announced the FDA has granted Orphan Drug Designation to TPST-1495, the company's dual receptor inhibitor of prostaglandin signaling, for the treatment of patients with Familial Adenomatous Polyposis. A Phase 2 study evaluating TPST-1495 in patients with FAP is set to begin in the current year. Data from this study are expected in 2026.

"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.

Shares of Tempest Therapeutics are up 2% in pre-market trade on Monday.

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