Investing.com -- Shares of Tempest Therapeutics Inc (NASDAQ: TPST ) climbed 2.3% premarket today after the company announced it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate TPST-1495, aimed at treating patients with Familial Adenomatous Polyposis (FAP).

The designation, announced on April 21, 2025, is a critical step for Tempest in advancing its clinical program. TPST-1495 is a novel dual receptor inhibitor of prostaglandin (PGE2) signaling. The Orphan Drug Designation is granted to treatments for rare diseases or conditions affecting fewer than 200,000 people in the United States and provides certain benefits, including market exclusivity upon regulatory approval, assistance in clinical trial design, and tax credits.

Stephen Brady, President and CEO of Tempest, stated, "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." He added that this designation underscores the company’s commitment to making a meaningful difference in the lives of patients and builds on prior momentum from designations received for another of their drugs, amezalpat, in hepatocellular carcinoma.

Tempest’s Phase 2 study for TPST-1495 is scheduled to begin within the year, with the Cancer Prevention Clinical Trials Network conducting the trial and funding provided by the National Cancer Institute (NCI) Division of Cancer Prevention. Results from the study are anticipated in 2026.

The Orphan Drug Designation has historically been a positive indicator for biotechnology companies, suggesting a supportive regulatory environment and potential for strategic partnerships or funding opportunities. Investors often view such milestones favorably, as they can lead to expedited development processes and a clearer pathway toward commercialization for the drug candidates involved.

Today’s uptick in Tempest’s stock price reflects the market’s optimism about the company’s prospects following the FDA’s recognition of TPST-1495’s potential in a niche and underserved medical area. As the company prepares for its upcoming Phase 2 study, stakeholders will be closely monitoring the progress of TPST-1495 and its implications for Tempest’s future in the biotech industry.

Though the stock initially shot up, it has since fallen and is now down 0.4% in premarket trading.

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