Welcome to our dedicated page for Tempest Therapeutics news (Ticker: TPST), a resource for investors and traders seeking the latest updates and insights on Tempest Therapeutics stock.
Tempest Therapeutics, Inc. develops clinical-stage cell therapy and small-molecule product candidates for cancer and related disease areas. News about TPST centers on its dual-targeting CAR-T platform, including TPST-2003, a CD19/BCMA CAR-T therapy under development for relapsed or refractory multiple myeloma, and clinical updates from programs such as REDEEM-1 and POEMS-1.
Company updates also cover CAR-T manufacturing and technology-transfer work, partner-supported development activities, business development and licensing priorities, and the amezalpat small-molecule program. Recurring corporate news includes financial results, pipeline portfolio changes following acquired CAR-T assets, leadership appointments, and governance or capital-structure matters tied to the company’s Nasdaq-listed common stock.
Tempest Therapeutics announced that the FDA has granted Orphan Drug Designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist, for the treatment of patients with hepatocellular carcinoma (HCC).
According to Sam Whiting, M.D., Ph.D., this designation highlights the critical need for new treatments for this challenging disease. Tempest plans to proceed with a pivotal phase 3 study for amezalpat in first-line HCC patients.
The designation follows positive data from a global randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in treating unresectable or metastatic HCC. Key results include:
- A six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for the amezalpat combination therapy.
- An objective response rate (ORR) of 30% compared to 13% for the control arm.
- Preserved survival benefit in key sub-populations, including PD-L1 negative disease and b-catenin mutated disease.
These outcomes are consistent with amezalpat’s mechanism of action, targeting both tumor cells and the patient’s immune system.
Tempest Therapeutics (Nasdaq: TPST) announced that its Compensation Committee has granted stock options to one employee under the company's 2023 Inducement Plan. The grant consists of nonqualified stock options to purchase 9,450 shares of common stock. The options will vest over a four-year period, with 25% vesting on the first employment anniversary and the remaining 1/48th vesting monthly thereafter, contingent on continued employment.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotech company focused on developing first-in-class targeted and immune-mediated cancer therapeutics, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's senior management will engage in a fireside chat on Tuesday, December 3, 2024 at 9:00 a.m. ET. Interested parties can access both live and archived recordings of the discussion through the investor section of Tempest's website at ir.tempesttx.com.
Tempest Therapeutics (NASDAQ: TPST) reported Q3 2024 financial results and key developments. The company received FDA's 'Study May Proceed' letter for a pivotal Phase 3 trial of amezalpat combination therapy for first-line HCC treatment. Tempest announced an agreement with Roche to support amezalpat's advancement and received NCI funding approval for TPST-1495 Phase 2 trial in FAP.
Financial highlights include: Q3 cash position of $22.1M, net loss of $10.6M ($0.41 per share), and R&D expenses of $7.6M. The company raised additional $19.9M through ATM offering post-quarter. Year-to-date operating cash burn was $22.9M with a net loss of $28.0M ($1.19 per share).
Tempest Therapeutics (Nasdaq: TPST) announced receiving a 'Study May Proceed' letter from the FDA for a pivotal Phase 3 trial of amezalpat (TPST-1120) combined with atezolizumab and bevacizumab. This trial will compare this combination against the current standard of care alone in treating first-line unresectable or metastatic hepatocellular carcinoma (HCC). Chief Medical Officer Sam Whiting highlighted the potential of amezalpat to improve patient survival, citing positive Phase 2 data. The company aims to advance this program to benefit patients with this life-threatening disease.
Tempest Therapeutics (Nasdaq: TPST) has announced an agreement with Roche to advance amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The study is set to begin in Q1 2025. This follows positive Phase 2 data showing a six-month improvement in median overall survival for the combination therapy compared to the control arm.
Key points:
- Roche will supply atezolizumab globally, while Tempest sponsors and leads the pivotal study
- Tempest retains all development and commercial rights to amezalpat
- FDA agreed on the Phase 3 study plan, including primary endpoint and statistical plan
- A pre-specified early efficacy analysis could potentially shorten the study's timeline by 8 months
Tempest Therapeutics (Nasdaq: TPST) has announced an extension to its duration stockholder rights plan. The Board of Directors adopted this amendment to extend the plan's duration until the Annual Meeting of Stockholders. The decision comes after significant milestones in the amezalpat program, including positive survival data compared to standard of care and FDA agreement on the Phase 3 path.
The Rights Plan aims to protect stockholders' long-term value and reduce the likelihood of control gain through open market accumulation without appropriate premiums. It will automatically expire after the 2025 Annual Meeting unless approved by stockholders. The plan becomes exercisable if an entity acquires 10% or more of Tempest's outstanding common stock (15% for certain passive institutional investors).
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapeutics, has announced the granting of stock options to two employees. The Compensation Committee of the company's Board of Directors approved nonqualified stock options for the purchase of 79,500 shares of common stock under Tempest's 2023 Inducement Plan.
The stock options have a four-year vesting period, with 25% vesting on the first anniversary of each employee's start date, followed by 1/48th of the total shares vesting monthly thereafter. The vesting is subject to continued employment on each vesting date. This announcement is made in accordance with Nasdaq Listing Rule 5635(c)(4), which pertains to inducement grants for new employees.
Tempest Therapeutics (Nasdaq: TPST) has appointed Sheldon Mullins as Vice President of Regulatory Affairs, strengthening its leadership team as it prepares for the pivotal study of amezalpat in first-line hepatocellular carcinoma (HCC). This appointment follows the recent addition of Troy Wagner as VP of Quality Assurance, both bringing late-stage development expertise to the company.
The company has also updated titles for Darrin Bomba and Henry Johnson to reflect their roles in late-stage development. CEO Stephen Brady emphasized the importance of expanding the team's global clinical capabilities as Tempest transitions to a late clinical company. Mullins brings over 25 years of regulatory affairs experience, spanning pre-IND to post-approval activities across various therapeutic areas.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotech company focused on developing targeted and immune-mediated cancer therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Dr. Sam Whiting, the company's chief medical officer and head of R&D, will deliver a presentation that will be available for on-demand viewing starting September 9, 2024, at 7:00 a.m. ET.
Investors and interested parties can access the presentation through the investor section of Tempest's website. This event provides an opportunity for Tempest to showcase its innovative approach to cancer treatment and potentially attract investor interest in its clinical-stage pipeline.