Tempest Therapeutics, Inc. TPST announced that it is planning to explore strategic options to advance the clinical studies on its pipeline candidates aimed at increasing stockholder value. The strategic alternatives may include potential mergers and acquisitions, partnerships, licensing arrangements, or other such transactions.
Tempest is developing amezalpat (TPST-1120), a PPAR-alpha antagonist, for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC), the most common type of liver cancer.
The company is also developing TPST-1495, a novel, highly selective and potent EP2-EP4 dual antagonist, for the treatment of familial adenomatous polyposis (FAP).
Shares of Tempest were up 6.3% in after-hours trading on April 9, following the announcement of the news.
Year to date, shares of Tempest have plunged 34.1% compared with the industry’s decline of 14.6%.
Image Source: Zacks Investment ResearchTPST's Development Plans for Amezalpat
Tempest has an agreement with Swiss pharmaceutical giant Roche RHHBY to evaluate amezalpat in combination with the latter’s standard-of-care combination therapy, Tecentriq (atezolizumab) and Avastin (bevacizumab), in the first-line treatment of unresectable or metastatic HCC.
The company has received clearance from the FDA to begin a pivotal phase III study evaluating amezalpat plus Roche’s standard-of-care combination therapy, Tecentriq and Avastin for tearing first-line unresectable or metastatic HCC.
Data from the ongoing global phase Ib/II study have shown that amezalpat, in combination with RHHBY’s standard-of-care combination therapy, Tecentriq and Avastin, led to a six-month improvement in median overall survival (OS) versus Tecentriq and Avastin alone in the first-line treatment of HCC.
The FDA has already granted a Fast Track and Orphan Drug designation to amezalpat for the treatment of HCC.
TPST's Development Plans for TPST-1495
Tempest has also received a “Study May Proceed” letter from the FDA to begin a phase II study on TPST-1495 for the treatment of FAP. The study is expected to begin later in 2025, with data from the same expected in 2026.
The FDA has granted Orphan Drug designation to TPST-1495 for the treatment of patients with FAP.
Per management, if successfully developed, amezalpat has blockbuster potential in first-line HCC while the development of TPST-1495 in FAP also holds promise. As part of the strategic alternative, Tempest is looking to secure partnerships to develop these promising candidates.
TPST's Zacks Rank & Stocks to Consider
Tempest currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ and Krystal Biotech, Inc. KRYS, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Jazz Pharmaceuticals’ earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.35. Year to date, shares of JAZZ have declined 10.6%.
JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have rallied 7.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.
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Roche Holding AG (RHHBY): Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report Krystal Biotech, Inc. (KRYS): Free Stock Analysis Report Tempest Therapeutics, Inc. (TPST): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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