This section highlights FDA-related milestones and regulatory updates for drugs developed by Tempest Therapeutics (TPST).
Over the past two years, Tempest Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TPST-2003, TPST-1120, and TPST-1495. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TPST-2003 FDA Regulatory Events
TPST-2003 is a drug developed by Tempest Therapeutics for the following indication: dual-targeting CAR-T therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TPST-2003
- Announced Date:
- February 25, 2026
- Indication:
- dual-targeting CAR-T therapy.
Announcement
Tempest Therapeutics, Inc. announced clinical data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, a CD19/BCMA dual-targeting CAR-T therapy.
AI Summary
Tempest Therapeutics reported clinical data from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003, a CD19/BCMA dual-targeting CAR-T therapy. As of Jan. 31, 2026, 36 patients had received one infusion of TPST-2003 (24 in a prior investigator trial and 12 in REDEEM-1). Patients in REDEEM-1 had a median of four prior lines of therapy.
All six patients currently evaluable for efficacy in REDEEM-1 (three at 1 x 10^6 cells/kg and three at 2 x 10^6 cells/kg) achieved complete responses (CR). Across both studies, 25 of 25 evaluable patients with measurable disease had an overall response (100% ORR). Tempest says the consistent responses support the reproducibility of its parallel dual-targeting CAR design and plans to present full data later in 2026.
Safety was favorable across doses: no Grade ≥3 cytokine release syndrome, one low-grade ICANS at the highest dose, and no Grade ≥3 neurotoxicity. Tempest intends to accelerate development toward a registrational study in 2026.
Read Announcement
TPST-1120 FDA Regulatory Timeline and Events
TPST-1120 is a drug developed by Tempest Therapeutics for the following indication: First-Line Regimen for Hepatocellular Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TPST-1120
- Announced Date:
- June 30, 2025
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. 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 patients with unresectable or metastatic hepatocellular carcinoma (HCC).
AI Summary
Tempest Therapeutics, Inc. announced that it has received approval from China’s National Medical Products Administration (NMPA) to begin a pivotal Phase 3 trial in patients with unresectable or metastatic hepatocellular carcinoma (HCC). The study will evaluate the effectiveness of amezalpat (TPST-1120) when combined with atezolizumab and bevacizumab, comparing this regimen to the current standard of care alone.
This trial is crucial as HCC remains a significant health challenge in China, which has the largest population of patients with this type of cancer. The NMPA’s clearance signals strong confidence in the potential of amezalpat to make a meaningful impact on patient outcomes. Tempest Therapeutics is optimistic that this pivotal trial will advance the development of novel treatment options for HCC and may lead to improved survival rates for patients battling this aggressive cancer.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- March 27, 2025
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, provided a corporate update.
AI Summary
Tempest Therapeutics provided a corporate update highlighting significant progress made during 2024. The company emphasized its development of amezalpat, a lead candidate for first-line liver cancer treatment. Notably, Tempest advanced its plans by securing an agreement with Roche to support a pivotal Phase 3 trial evaluating amezalpat in combination with standard therapies. This collaboration marks an important milestone in their effort to improve patient outcomes in hepatocellular carcinoma.
In addition to its clinical advancements, Tempest shared its financial performance, reporting a decrease in cash reserves and an operating loss for the year. The company also expanded its leadership team by appointing new experts in quality assurance and regulatory affairs to strengthen its global clinical expertise. Tempest remains focused on executing its development plans and securing resources to drive its promising drug candidates forward.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- February 10, 2025
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC).
AI Summary
Tempest Therapeutics announced that the FDA has granted Fast Track Designation to its new drug amezalpat (TPST-1120). This oral, small molecule acts as a selective PPAR⍺ antagonist and is designed to treat hepatocellular carcinoma (HCC), a serious form of liver cancer with few effective treatment options. Fast Track Designation is given to promising therapies for serious conditions, helping to speed up drug development and review. With this status, Tempest Therapeutics will work closely with the FDA and other regulatory agencies to advance the therapy more efficiently. This milestone highlights the company’s commitment to accelerating promising treatments for challenging diseases. It also provides hope that amezalpat could offer a much-needed new option for HCC patients in the future.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- January 6, 2025
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. 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).
AI Summary
Tempest Therapeutics, Inc. announced that the U.S. FDA granted Orphan Drug Designation for its drug candidate, amezalpat (TPST-1120). This oral, small molecule, selective PPAR⍺ antagonist is designed to treat hepatocellular carcinoma (HCC), a challenging and aggressive form of liver cancer. The designation underscores the urgent need for new therapies as many HCC patients currently have limited treatment options. FDA recognition offers benefits such as market exclusivity and tax credits that could accelerate the drug's development. With promising results from global studies showing improved overall survival and response rates when added to standard care, Tempest is planning a pivotal Phase 3 trial in first-line HCC patients. The move highlights Tempest’s commitment to offering innovative cancer care and improving the lives of those affected by this difficult-to-treat disease.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- October 10, 2024
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. announced an agreement with Roche 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 pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, a form of liver cancer with high unmet need.
AI Summary
Tempest Therapeutics, Inc. has announced an agreement with Roche to move a promising new treatment into a pivotal Phase 3 trial. The study will evaluate amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq®) and bevacizumab, which together form the current standard of care for patients with unresectable or metastatic hepatocellular carcinoma (HCC)—a challenging form of liver cancer that has high unmet medical needs. Under the agreement, Roche will provide atezolizumab globally, while Tempest will sponsor and lead the trial. This collaboration builds on earlier studies where combining these drugs showed improved patient survival compared to standard treatment alone. The new pivotal trial aims to further assess the effectiveness of this combination as a first-line treatment option, potentially offering a significant advancement in therapy for those battling advanced liver cancer.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- August 15, 2024
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. announced positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC).
AI Summary
Tempest Therapeutics, Inc. announced positive feedback from the FDA following its end-of-Phase 2 meeting regarding amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for treating first-line unresectable or metastatic hepatocellular carcinoma (HCC). The FDA agreed with the design of the pivotal Phase 3 trial, which will use the currently tested amezalpat dose and schedule that demonstrated success during Phase 2. Overall survival will serve as the primary endpoint, and the FDA approved the plan to include an early efficacy analysis that could shorten the time to the main study outcome by up to eight months.
This clear agreement between Tempest and the FDA supports the planned design of the Phase 3 trial, bolstering confidence that the positive survival results seen in the Phase 2 trial can be replicated for patients with advanced HCC.
Read Announcement- Drug:
- TPST-1120
- Announced Date:
- June 20, 2024
- Indication:
- First-Line Regimen for Hepatocellular Carcinoma
Announcement
Tempest Therapeutics, Inc. announced new positive data from the ongoing global randomized Phase 1b/2 clinical study in which amezalpat2 (TPST-1120), Tempest's PPAR⍺ antagonist, delivered a six-month improvement in median overall survival ("OS") advantage when combined with atezolizumab and bevacizumab in a comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma ("HCC").
AI Summary
Tempest Therapeutics announced promising data from its global Phase 1b/2 clinical study in patients with unresectable or metastatic hepatocellular carcinoma (HCC). In this trial, the company’s oral PPARα antagonist, amezalpat (TPST-1120), was added to the standard treatment of atezolizumab and bevacizumab. The new results show that patients receiving the three-drug combination had a median overall survival of 21 months compared to 15 months for those on the standard treatment—a six-month improvement. Additionally, 50% of patients receiving amezalpat remain under survival follow-up, and the hazard ratio for overall survival was 0.65, indicating a robust, stable benefit since the initial analysis. These encouraging findings support the potential of amezalpat to enhance first-line treatment outcomes in advanced HCC and set the stage for further Phase 3 studies.
Read Announcement
TPST-1495 FDA Regulatory Events
TPST-1495 is a drug developed by Tempest Therapeutics for the following indication: Designed to block the receptors EP2 and EP4 in the prostaglandin pathway.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TPST-1495
- Announced Date:
- April 21, 2025
- Indication:
- Designed to block the receptors EP2 and EP4 in the prostaglandin pathway
Announcement
Tempest Therapeutics, Inc. 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).
AI Summary
Tempest Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its innovative drug TPST-1495. This novel dual receptor inhibitor works by blocking prostaglandin (PGE2) signaling and is being developed to treat Familial Adenomatous Polyposis (FAP), a rare inherited condition that leads to numerous polyps with a high risk of cancer. The ODD status is significant because it acknowledges TPST-1495 as a promising therapy for a disease with limited treatment options. It also brings potential benefits such as tax credits, fee waivers, and up to seven years of market exclusivity if the drug is approved. This milestone reflects Tempest Therapeutics’ commitment to addressing unmet medical needs and advancing innovative treatments for patients suffering from rare and challenging conditions like FAP.
Read Announcement- Drug:
- TPST-1495
- Announced Date:
- March 13, 2025
- Indication:
- Designed to block the receptors EP2 and EP4 in the prostaglandin pathway
Announcement
Tempest Therapeutics, 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 prostaglandin (PGE2) signaling, in a Phase 2 clinical trial for the treatment of patients with Familial Adenomatous Polyposis (FAP).
AI Summary
Tempest Therapeutics recently announced that the Cancer Prevention Clinical Trials Network received a “Study May Proceed” letter from the FDA. This letter allows the network to evaluate TPST-1495, a new dual receptor inhibitor that targets prostaglandin (PGE2) signaling. The Phase 2 clinical trial will focus on treating patients with Familial Adenomatous Polyposis (FAP), a condition that greatly increases the risk of developing multiple gastrointestinal cancers. The trial, which is supported by the National Cancer Institute’s Division of Cancer Prevention, will assess the drug’s effectiveness in reducing the duodenal polyp burden in patients who have already undergone colectomy. Tempest Therapeutics sees this advancement as an important step toward creating innovative treatment options for those facing this high-risk disease, with the study set to begin later this year.
Read Announcement
