Second clinical program entering Phase 2 with data expected 2026BRISBANE, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the Cancer Prevention Clinical Trials Network received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate TPST-1495, the company’s novel dual receptor inhibitor of pro ...

Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC Amezalpat builds momentum with both Fast Track and Orphan Drug Designations BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ameza ...

BRISBANE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC). “Receiving orphan drug designation for a ...

BRISBANE, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that members of senior management will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024 at 9:00 a.m. ET. To access the live or archived recording of the discussion, please visit the investor section of the Temp ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . | --- | --- | |----------------------------------------------------------------------------------------------------------------------|-------- ...

Building upon a successful end-of-Phase 2 meeting, received FDA “Study May Proceed” letter for pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line HCCAnnounced agreement with Roche to support advancement of amezalpat into first-line HCC pivotal Phase 3 trialReceived final funding approval from NCI to move TPST-1495 into a Phase 2 trial in FAPExpanded leadership team to strengthen global clinical expertise BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therape ...

Exhibit 99.1 Tempest Reports Third Quarter 2024 Financial Results and Provides Business Update - Building upon a successful end-of-Phase 2 meeting, received FDA "Study May Proceed" letter for pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line HCC - Announced agreement with Roche to support advancement of amezalpat into first-line HCC pivotal Phase 3 trial - Received final funding approval from NCI to move TPST-1495 into a Phase 2 trial in FAP - Expanded leadership team to ...

Tempest Therapeutics Inc. TPST stock is trading higher on Thursday, with a strong session volume of over 23 million as per data from Benzinga Pro. The company entered into an agreement with Roche Holdings AG RHHBY to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line treatment of liver cancer. Under the agreement, Roche ...

Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and schedule Overall survival, the strongest result from the Phase 2 trial, will be the primary study endpoint Agreed-upon early efficacy analysis could reduce time to primary read-out significantly BRISBANE, Calif., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today ...

Unveiled new positive survival data for amezalpat (TPST-1120) in randomized first-line hepatocellular carcinoma ("HCC") study demonstrating: Survival benefit maintained across key subpopulations a six-month improvement over control arm in median survival a strong 0.65 hazard ratio, maintained since 0.59 observed 10 months earlier Advancing amezalpat towards a pivotal Phase 3 trial in first-line HCC Planning to move TPST-1495 into a Phase 2 in FAP BRISBANE, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Tempest T ...