FDA Fast Track Designation Granted To Tempest's Amezalpat For Hepatocellular Carcinoma

(RTTNews) - Tempest Therapeutics, Inc. (TPST), a clinical-stage biotechnology company, Monday announced that its lead drug candidate, amezalpat or TPST-1120, has been granted Fast Track Designation by the U.S. Food and Drug Administration or FDA for the treatment of hepatocellular carcinoma or HCC.

Amezalpat is an oral, small-molecule selective PPAR antagonist, which works by targeting tumor cells directly and modulating immune suppressive cells within the tumor microenvironment.

The drug has demonstrated promising results in early-stage clinical trials, particularly in combination with atezolizumab and bevacizumab.

In a randomized global Phase 1b/2 study, the combination of amezalpat with these therapies showed a significant improvement in overall survival or OS compared to standard treatments, including a six-month median OS improvement and favorable results in difficult-to-treat patient populations, such as those with PD-L1 negative disease.

In addition to the Fast Track designation, amezalpat was granted Orphan Drug Designation or ODD by the FDA earlier in January 2025.

This designation reflects the unmet need for better treatments for HCC, a cancer with increasing mortality rates, particularly in parts of East Asia, Europe, and the United States.

The Fast Track Designation will enable Tempest Therapeutics to expedite the development and review of amezalpat, including facilitating more frequent interactions with the FDA and the potential for accelerated approval.

This is a crucial step for bringing a potential new treatment option to patients suffering from HCC, a disease with few effective treatment options, especially in its advanced stages.

Tempest's clinical trial program for amezalpat is ongoing, with additional data expected from the Phase 2a trials targeting HCC and other solid tumors.

The company is optimistic about amezalpat's potential to become a key therapeutic option for patients with HCC, as well as its broader applications in cancer treatment.

Currently, TPST is trading at $0.87 down by 0.03%.

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