BRISBANE, Calif. - Tempest Therapeutics Inc. (NASDAQ:TPST), a biotechnology firm specializing in cancer treatment development, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 3 clinical trial for the drug amezalpat, used in treating hepatocellular carcinoma (HCC). The company announced the consensus on the pivotal study's design and endpoints following an end-of-Phase 2 meeting with the FDA.
The planned global study will evaluate the efficacy of amezalpat in combination with atezolizumab and bevacizumab against the current standard of care for patients with unresectable or metastatic HCC. The primary endpoint of the trial will be overall survival, a metric where the Phase 2 trial showed promising results. The FDA has agreed on the appropriateness of the current dosage and schedule of amezalpat for the Phase 3 trial.
An early efficacy analysis, as agreed upon with the FDA, could potentially shorten the time to the primary analysis by up to eight months, expediting the study's findings. This analysis is part of the broader statistical plan for the Phase 3 trial.
Amezalpat is an oral, small molecule antagonist of PPARα, which has shown potential both in direct cancer cell targeting and in modulating the tumor microenvironment. The upcoming Phase 3 trial, set to commence in the first quarter of 2025, builds on the data from an ongoing global randomized Phase 1b/2 study that demonstrated clinical superiority of amezalpat in combination therapy.
Tempest Therapeutics is advancing a portfolio of small molecule product candidates with tumor-targeted and immune-mediated mechanisms intended to treat a broad spectrum of tumors. The company has cautioned investors that forward-looking statements are not guarantees of future performance and that actual results may differ due to a variety of factors.
This article is based on a press release statement from Tempest Therapeutics, Inc. The information provided herein reflects the company's current plans for the development of its drug candidate, amezalpat, and its interactions with regulatory authorities.
InvestingPro Insights
As Tempest Therapeutics Inc. (NASDAQ:TPST) gears up for its Phase 3 clinical trial, investors are keeping a close eye on the company's financial health and market performance. According to InvestingPro data, Tempest Therapeutics currently holds a market capitalization of $30 million USD. This valuation comes amidst a challenging period for the company, as reflected in a 1-month price total return of -46.4% and a 3-month price total return of -64.79%, indicating significant recent declines in the stock price.
InvestingPro Tips highlight several critical aspects of Tempest Therapeutics' financial status. The company holds more cash than debt on its balance sheet, which could be a positive sign for investors looking for stability. However, it's important to note that analysts have raised concerns about the company's cash burn rate and do not anticipate profitability this year. Additionally, the stock has experienced a considerable hit over the last month and six months, with the price falling significantly during these periods.
These financial insights are particularly relevant for investors considering the potential risks and rewards associated with Tempest Therapeutics' development of amezalpat. With the company not expected to pay dividends and facing weak gross profit margins, investment decisions should be made with caution. For those interested in a deeper dive into the company's financials and future prospects, InvestingPro offers additional tips and metrics for Tempest Therapeutics, accessible at https://www.investing.com/pro/TPST.
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