TPST Stock Up on EMA's Orphan Drug Tag for Liver Cancer Therapy

Tempest Therapeutics TPST announced that the European Medicines Agency (EMA) has granted an orphan drug designation (ODD) to its oral PPAR-alpha antagonist, amezalpat (TPST-1120), for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer.

Shares of Tempest were up 14.6% yesterday following the announcement of the news.

TPST's Ongoing Development Activities With 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), for the first-line treatment of unresectable or metastatic HCC.

Besides EMA’s orphan drug tag, amezalpat received the FDA’s ODD and Fast Track designation for treating HCC earlier this year.

All these designations were based on positive data from the phase Ib/II study, which evaluated amezalpat in combination with RHHBY’s standard-of-care combination therapy, Tecentriq and Avastin, for the first-line treatment of unresectable or metastatic HCC.

Data from the phase Ib/II study have shown that amezalpat, in combination with RHHBY’s standard-of-care combination therapy, Tecentriq and Avastin, demonstrated superior outcomes across multiple study endpoints, including overall survival, compared to the standard of care alone.

Year to date, shares of Tempest have plunged 26.8% against the industry’s rise of 10.4%.

TPST Developing Another Candidate TPST-1495

The company is developing TPST-1495, a novel, highly selective and potent EP2-EP4 dual antagonist, for the treatment of familial adenomatous polyposis (FAP).

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 also granted an Orphan Drug designation to TPST-1495 for the treatment of patients with FAP.

Tempest is currently exploring strategic options to advance the clinical studies on its pipeline candidates aimed at increasing stockholder value.

TPST's Zacks Rank & Other Stocks to Consider

Tempest currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are Lexicon Pharmaceuticals LXRX and Chemomab Therapeutics CMMB, each carrying a Zacks Rank #2 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 Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 2.9%.

LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.

In the past 60 days, estimates for Chemomab Therapeutics’ loss per share have narrowed from 70 cents to 60 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 80 cents to 70 cents. Year to date, shares of CMMB have declined 27.9%.

CMMB’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 5.00%.

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This article originally published on Zacks Investment Research (zacks.com).

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