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Investing.com -- Shares of Tempest Therapeutics Inc (NASDAQ:TPST) climbed 5.3% following the announcement that the European Medicines Agency (EMA) has granted Orphan Drug Designation to its cancer treatment drug, amezalpat. This designation is for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer.
The positive market response comes on the heels of the EMA’s recognition, which adds to the momentum created by the U.S. Food and Drug Administration’s (FDA) earlier grants of both Orphan Drug Designation and Fast Track Designation for amezalpat. The company’s president and CEO, Stephen Brady, expressed his satisfaction with the EMA’s decision, emphasizing the significant unmet need in liver cancer treatment and the potential of amezalpat to provide meaningful benefits to patients.
The surge in stock value reflects investor optimism after the company reported earlier this year that amezalpat had shown promising results in a global Phase 1b/2 clinical study. The study evaluated the efficacy and safety of amezalpat in combination with standard-of-care atezolizumab and bevacizumab versus the standard-of-care alone. Notably, the combination therapy demonstrated a six-month improvement in median overall survival and a hazard ratio of 0.65, indicating a 35% reduction in the risk of death for patients receiving the amezalpat combination therapy.
Moreover, the survival benefit was preserved across key sub-populations, including patients with PD-L1 negative disease. This aligns with the proposed mechanism of action for amezalpat, which is designed to target both tumor cells and the immune system.
Investors are reacting to these developments as they underscore the company’s progress in advancing a potentially significant treatment for HCC. While this news is promising for Tempest Therapeutics, it’s important to note that the journey from clinical trials to market success is complex and subject to regulatory approvals and further testing. The Orphan Drug Designation by the EMA, however, does provide regulatory incentives and could help streamline the development process for amezalpat.
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