Builds on clearances already received by FDA and EMAChina has the largest population of patients with hepatocellular carcinoma in the world BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal trial to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in the first-line treatment of pa

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /PRNewswire/ -- After the close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers are optimistic, especially in the fields of immunotherapy, Car T-cell therapy, liquid biopsies, breast cancer, AI, and even exercise. However, with reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For inv

BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock (or common stock equivalent). The closing of the offering is expected to occur on or about June 12, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & C

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to standard of care alone BRISBANE, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotechnology company with a pipeline of first-in-clas

Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual MeetingGranted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)Received FDA "Study May Proceed" letter for Phase 2 trial of TPST-1495 for the treatment of FAPGranted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC) BRISBANE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to figh

BRISBANE, Calif., April 28, 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 a presentation of new data supporting the immune component of amezalpat's purported dual mechanism of action that reinforces its potential as a novel cancer treatment at the 2025 American Association for Cancer Research (AACR) Annual Meeting. "The data presented at the AACR Annual Meeting show that amezalpat reduced tumor promoting immunosuppression by M2 macrophages and T regulatory cells resulting in immune activation. These data support the immune

BRISBANE, Calif., April 21, 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 TPST-1495, the company's novel dual receptor inhibitor of prostaglandin (PGE2) signaling, for the treatment of patients with Familial Adenomatous Polyposis (FAP). "Receiving orphan drug designation for TPST-1495, our second clinical program, is a significant milestone in our mission to bring innovative therapies to patients with unmet medical need," said Stephen Br

Amezalpat (TPST-1120) is Phase 3-ready: completed FDA and EMA interactions for first-line pivotal study in hepatocellular carcinoma (HCC); global investigator support in placeAwarded both Orphan Drug & Fast Track designations for amezalpat based on positive randomized Phase 2 data in first-line HCC Received FDA "Study May Proceed" letter for TPST-1495 in a Phase 2 trial for the treatment of familial adenomatous polyposis (FAP); data expected 2026 BRISBANE, Calif., April 09, 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 c

• Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma (HCC)• Announced Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into First-Line HCC Pivotal Trial• Received FDA "Study May Proceed" letter for Phase 2 trial of TPST-1495 for the treatment of Familial Adenomatous Polyposis (FAP) BRISBANE, Calif., March 27, 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 reported financial results for the year ended 2024 and provided a corporat

BRISBANE, Calif., March 25, 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 an abstract highlighting data supporting the immune component of amezalpat's purported mechanism of action has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30, 2025 in Chicago, IL. Poster presentation details: Title:Amezalpat, a peroxisome proliferator-activated receptor alpha (PPARα) antagonist, inhibits suppressive macrophage development, activation and fu

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Scotiabank downgraded Tempest Therapeutics from Sector Outperform to Sector Perform

H.C. Wainwright downgraded Tempest Therapeutics from Buy to Neutral

Scotiabank initiated coverage of Tempest Therapeutics with a rating of Sector Outperform and set a new price target of $13.00

Jefferies initiated coverage of Tempest Therapeutics with a rating of Buy and set a new price target of $15.00

William Blair initiated coverage of Tempest Therapeutics with a rating of Outperform

HC Wainwright & Co. initiated coverage of Tempest Therapeutics with a rating of Buy and set a new price target of $51.00

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USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /PRNewswire/ -- After the close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers are optimistic, especially in the fields of immunotherapy, Car T-cell therapy, liquid biopsies, breast cancer, AI, and even exercise. However, with reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For inv

BRISBANE, Calif., Sept. 18, 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 the appointment of Sheldon Mullins as Vice President, Regulatory Affairs. Mr. Mullins' presence on the team builds upon the recent addition of Troy Wagner as Vice President of Quality Assurance, who brought additional late-stage experience to the company. Additionally, in connection with the plan to advance amezalpat into a pivotal study in first-line HCC patients and to reflect their roles in late-stage development, the titles of Darrin Bomba and Henry John

BRISBANE, Calif., Aug. 21, 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 the appointment of Troy M. Wagner as Vice President of Quality Assurance. "Troy brings a wealth of experience in late-stage product development, including managing quality systems across a range of global clinical studies and assisting with global regulatory filings. We look forward to her contributions as we move towards Phase 3 development of amezalpat to treat hepatocellular carcinoma and are thrilled to have her join the Tempest leadership team,"

BERKELEY, Calif., Nov. 11, 2021 /PRNewswire/ -- Actym Therapeutics, Inc. today announced the appointment of Chan Whiting, Ph.D. as Chief Development Officer. Chan brings over 20 years of drug development experience within the biotechnology industry. As CDO, Chan will play a key leadership role in advancing Actym's pipeline of first-in-class, systemically administered therapeutics that re-program the immunosuppressive microenvironment in solid tumors.   Actym Therapeutics hires Dr. Chan Whiting as Chief Development Officer."Chan has significant experience advancing novel cancer

First patients dosed in first line, randomized, global Phase 1b/2 hepatocellular carcinoma ("HCC") study of TPST-1120 combination regimen, in collaboration with F. Hoffmann La RocheExclusive rights to novel oncology target in-licensed from the lab of Russell Vance, Ph.D., at the University of California at Berkeley ("U.C. Berkeley") SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results and provided a corporate update for the third quarter ended September 30, 2021.

With this important addition to its executive team, Science 37 will further advance its mission to accelerate clinical trials by enabling universal access to patients and providers Science 37, pioneer of the Decentralized Clinical Trial Operating System™ (DCT OS), today announced that Christine Pellizzari has joined the senior executive team as Chief Legal Officer. In this role, Ms. Pellizzari will use her nearly 30 years of legal expertise to manage the legal and quality functions to help advance Science 37's mission to enable universal access to clinical research for patients and providers, anywhere. This press release features multimedia. View the full release here: https://www.business

SOUTH SAN FRANCISCO, Calif., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST) ("Tempest"), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today announced the appointment of Ronit Simantov, M.D., a seasoned and accomplished industry veteran as well as hematology and oncology expert, to the company's board of directors. Dr. Simantov brings more than 20 years of experience in oncology research and product development. "As we mature as a public company and advance our programs in the clinic, we are thrilled to expand our board with the expertise, capabilities and cali

BRISBANE, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST) ("Tempest" or the "Company"), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that its Board of Directors (the "Board") has adopted an amendment to its existing limited duration stockholder rights plan (as amended, the "Rights Plan") to extend the duration of the Rights Plan until the Annual Meeting of Stockholders. "Given the significant milestones reached this year in the amezalpat program – the positive survival data compared to standard of care and broad agreement with FDA on the Phase 3 path – coupled

21 months median OS in amezalpat arm vs. 15 in control arm 50% (20/40) of patients on amezalpat arm remain in survival follow up 0.65 hazard ratio, maintained since 0.59 observed in primary analysis 10 months earlier Early and persistent separation of survival curves OS is the primary regulatory endpoint for first-line HCCCompany to host webcast conference call today at 8:30am ET BRISBANE, Calif., June 20, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced new positive data from the ongoing global randomized Phase 1b/2 clinica

BRISBANE, Calif., June 18, 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 the company plans to report new data from the global randomized Phase 1b/2 combination study of amezalpat (TPST-1120) with atezolizumab and bevacizumab in first-line treatment of hepatocellular carcinoma (HCC) in a premarket press release followed by a webcasted conference call with associated slide presentation on Thursday, June 20, 2024 at 8:30 a.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register onlin

BRISBANE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, today announced that its Board of Directors (the "Board") has adopted a limited duration stockholder rights plan, effective immediately (the "Rights Plan"). Stephen Brady, president and chief executive officer of Tempest, stated: "Today we announced exciting new randomized data in first-line HCC from our lead program, TPST-1120. Unfortunately, Tempest, like many other biotechnology companies, continues to experience a significant and ongoing dislocation in the tradi

New data package reveals improvements in multiple categories for TPST-1120 combined with atezolizumab + bevacizumab versus standard of care atezolizumab + bevacizumab in a global Phase 1b/2 study30% confirmed ORR achieved in TPST-1120 arm compared to 13.3% for atezolizumab + bevacizumab in the control arm, a substantial increase specific to the TPST-1120 arm compared to the previous data cut of 17.5% versus 10.3% in the control armResults show a favorable PFS and OS hazard ratio for TPST-1120 arm versus atezolizumab + bevacizumab control arm Biomarker data for the TPST-1120 arm demonstrate: increased confirmed ORR of 43% and DCR of 100% in subpopulation of patients with a beta catenin mutati

BRISBANE, Calif., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced the company plans to report new and updated data from the global randomized Phase 1b/2 combination study of TPST-1120 with atezolizumab and bevacizumab in first-line treatment of hepatocellular carcinoma (HCC) in a premarket press release on Wednesday, October 11, 2023, followed by a webcasted conference call with associated slide presentation at 8:30 a.m. ET on Wednesday, October 11, 2023. To join the conference call via phone and participate in the

Positive randomized data with TPST-1120 combined with atezolizumab + bevacizumab compared head-to-head with atezolizumab + bevacizumabThe addition of TPST-1120 resulted in a clinically-meaningful improvement in both confirmed and unconfirmed RECIST responsesThe number of patients on treatment and on study markedly favors the TPST-1120 armCompany to host webcast conference call today at 8:30 a.m. ET BRISBANE, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced positive early results from a global randomized Ph

BRISBANE, Calif., April 27, 2023 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced the company plans to report early data from its Phase 1b/2 combination study of TPST-1120 in first-line hepatocellular carcinoma in a premarket press release and webcast Friday, April 28, 2023. Tempest will host a conference call accompanied by a slide presentation at 8:30 a.m. ET on Friday, April 28th. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and u