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. (TPST) is a biotechnology company focused on the development of small molecule therapeutics that modulate anti-tumor immunity pathways.
Tempest's mission is to pioneer novel treatments for cancer by leveraging a balanced and deep pipeline of small molecule therapeutics. These therapeutics are designed to modulate distinct immune response pathways that are crucial for mounting an effective anti-tumor response. Developed by Inception Sciences, a Versant Ventures-affiliated drug discovery engine, the company’s pipeline includes first-in-class and best-in-class molecules.
The company’s leading product candidates, TPST-1120 and TPST-1495, are in the clinical stage. TPST-1120 aims to inhibit its target to promote anti-tumor immunity, while TPST-1495 is designed to activate tumor-specific immune responses. These candidates are developed to address significant unmet medical needs across a range of cancers.
Tempest Therapeutics has assembled a highly experienced team of drug developers specializing in small molecules and immuno-oncology. This team is dedicated to advancing these programs through clinical trials and eventually to market. The company's robust research and development efforts are backed by a syndicate of leading venture capital firms based in the United States and China, providing strong financial support and strategic guidance.
Recent achievements for Tempest Therapeutics include the initiation and progress of randomized clinical trials, showcasing the company’s commitment to evidence-based development and regulatory approval. With a focus on innovation and patient outcomes, Tempest Therapeutics is well-positioned to make significant contributions to the field of oncology.
For more detailed information on the company’s latest updates, news, and financial performance, you can contact Sylvia Wheeler and Aljanae Reynolds at Wheelhouse Life Science Advisors.
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.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapeutics, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee granted one employee nonqualified stock options to purchase 60,000 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 the employee's start date, followed by 1/48th of the total shares vesting monthly thereafter. This vesting schedule is subject to continued employment on each vesting date.
Tempest Therapeutics (Nasdaq: TPST) has appointed Troy M. Wagner as Vice President of Quality Assurance. This move aims to strengthen the company's global clinical expertise as it progresses towards Phase 3 development of amezalpat, its lead oncology candidate for treating hepatocellular carcinoma (liver cancer). Wagner brings over 30 years of experience in quality and clinical compliance, having previously held leadership positions at Tricida, Jubilant Life Sciences, Alcon, and other pharmaceutical companies. Her expertise in late-stage product development, global clinical studies, and regulatory filings is expected to contribute significantly to Tempest's goal of bringing amezalpat to patients.
Tempest Therapeutics (Nasdaq: TPST) announced a successful end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in treating first-line hepatocellular carcinoma (HCC). The FDA and Tempest reached broad agreement on the pivotal Phase 3 study plan, including:
1. Using the current amezalpat dose and schedule
2. Setting overall survival as the primary endpoint
3. Implementing an early efficacy analysis that could significantly reduce time to primary read-out
The planned Phase 3 study closely mirrors the randomized Phase 2 study, which showed a strongly favorable hazard ratio for overall survival. This outcome gives Tempest confidence in the potential success of the Phase 3 trial for amezalpat in combination with atezolizumab and bevacizumab for first-line unresectable or metastatic HCC.
Tempest Therapeutics (Nasdaq: TPST) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. New positive survival data for amezalpat (TPST-1120) in first-line hepatocellular carcinoma (HCC) study, showing a six-month improvement in median survival over the control arm.
2. Plans to advance amezalpat towards a pivotal Phase 3 trial in first-line HCC.
3. Intention to move TPST-1495 into a Phase 2 study for Familial Adenomatous Polyposis (FAP).
4. Q2 2024 financial results: $31.1 million in cash and cash equivalents, net loss of $9.6 million, and net loss per share of $0.42.
5. Increased R&D expenses to $5.8 million and G&A expenses to $3.7 million for the quarter.
Tempest Therapeutics announced positive survival data from its Phase 1b/2 trial of amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for treating unresectable or metastatic hepatocellular carcinoma (HCC). The trial showed a median overall survival (OS) of 21 months in the amezalpat arm versus 15 months in the control arm, marking a six-month improvement.
Key findings include a hazard ratio of 0.65, with 50% of patients in the amezalpat arm still in survival follow-up. The trial demonstrated a confirmed objective response rate (cORR) of 30% in the amezalpat arm compared to 13.3% in the control arm. Amezalpat was well tolerated, with a manageable safety profile.
The company will host a webcast conference call to discuss these results.
Tempest Therapeutics (Nasdaq: TPST) will release new data from its global randomized Phase 1b/2 study of amezalpat (TPST-1120), combined with atezolizumab and bevacizumab, in the first-line treatment of hepatocellular carcinoma (HCC). The announcement will be made in a premarket press release on June 20, 2024, followed by a webcasted conference call at 8:30 a.m. ET. The study aims to explore the efficacy and safety of this combination therapy in treating HCC. Participants can join the conference call by pre-registering online to receive the necessary telephone number and unique passcode. The live webcast and a 30-day audio replay will be available on the Tempest website.
Tempest Therapeutics (Nasdaq: TPST) announced on June 7, 2024, that its Compensation Committee has granted stock options to purchase 14,000 shares to an employee. This grant is under the company's 2023 Inducement Plan and is compliant with Nasdaq Listing Rule 5635(c)(4). The stock options will vest over four years, with 25% vesting after the first year and the remaining shares vesting monthly over the next three years, contingent upon continued employment.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapies, announced participation in two investor conferences.
Management will present at TD Cowen's 5th Annual Oncology Innovation Summit on May 29, 2024, at 2:00 p.m. ET and at the Jefferies Global Healthcare Conference on June 5, 2024, at 4:00 p.m. ET.
Recordings of these events will be available on the Tempest investor relations website.
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