Tonix Pharmaceuticals stock halted ahead of FDA approval news
BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a biotechnology firm with a market capitalization of $25.5 million focused on developing cancer treatments, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for its drug TPST-1495. According to InvestingPro data, the company’s stock currently trades at $7.28, down significantly from its 52-week high of $49.27. This designation is for the treatment of Familial Adenomatous Polyposis (FAP), a rare genetic condition that significantly increases the risk of developing cancer.
The FDA’s ODD status is awarded to promote the development of drugs for diseases affecting fewer than 200,000 people in the U.S. It provides a range of incentives, including tax credits, FDA fee waivers, and market exclusivity for seven years post-approval.
TPST-1495 is a novel dual receptor inhibitor targeting prostaglandin (PGE2) signaling pathways. FAP, the disease in question, involves the development of numerous polyps in the gastrointestinal tract, which can lead to cancer. Currently, there are no approved medical therapies for FAP, which affects about one in 5,000 to 10,000 individuals in the U.S. The standard treatment for FAP is surgical, with patients typically undergoing a colectomy to prevent cancer development.
Stephen Brady, President and CEO of Tempest, remarked on the significance of this milestone, emphasizing the company’s commitment to addressing unmet medical needs. This designation follows the company’s previous achievements, including designations received for another of its drugs, amezalpat, for hepatocellular carcinoma. InvestingPro analysis shows the company maintains a healthy current ratio of 2.21, with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn.
The upcoming Phase 2 clinical trial for TPST-1495, funded by the National Cancer Institute’s Division of Cancer Prevention, is expected to commence this year, with data anticipated in 2026.
Tempest Therapeutics operates from Brisbane, California, and is known for its diverse portfolio of small molecule product candidates in various stages of clinical development.
This news is based on a press release statement and the information provided is intended to reflect the company’s current expectations and projections. It’s important to note that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. Investors are advised to not solely rely on these statements for making investment decisions.
In other recent news, Tempest Therapeutics reported earnings for the fourth quarter and full-year 2024, which did not meet expectations from both H.C. Wainwright and consensus estimates. The company posted an earnings per share of ($0.34) for the quarter and ($1.50) for the year, falling short of the anticipated figures. Tempest is actively exploring strategic alternatives, including potential mergers and partnerships, to enhance stockholder value and advance its clinical programs. The company is also moving forward with a Phase 2 trial for TPST-1495, targeting Familial Adenomatous Polyposis, with support from the National Cancer Institute. H.C. Wainwright downgraded Tempest’s stock rating from Buy to Neutral, citing broader macroeconomic challenges rather than issues with the company’s performance. Additionally, Tempest announced a 1-for-13 reverse stock split, which will consolidate shares and potentially increase the market price of its common stock. The company remains focused on advancing its lead clinical program for amezalpat, with a Phase 3 study planned in collaboration with Roche. H.C. Wainwright also adjusted Tempest’s stock price target to $16, down from $47, while maintaining a Buy rating due to ongoing financing risks and timeline adjustments.
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