Why Is Small-Cap Tempest Therapeutics Stock Trading Higher On Thursday?
Why Is Small-Cap Tempest Therapeutics Stock Trading Higher On Thursday?
On Thursday, Tempest Therapeutics Inc. (NASDAQ:TPST) announced feedback from its end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC).
周四，Tempest Therapeutics Inc. (NASDAQ: TPST) 宣布其关于一线不可切除或转移性肝细胞癌（HCC）治疗中 TPSt-1120 与 atezolizumab 和 bevacizumab 的结局二期会议与 FDA 的反馈。
Roche Holding AG's (OTC:RHHBY) Genentech sells bevacizumab as Avastin and atezolizumab as Tecentriq.
罗氏（OTC: RHHBY）的子公司 Genentech 将 bevacizumab 命名为 Avastin，而 atezolizumab 命名为 Tecentriq。
"Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first-line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study, and the strongly favorable hazard ratio for overall survival observed at topline analysis of Phase 2, confirmed at the latest survival follow-up, gives us confidence in the potential success of Phase 3," said Sam Whiting, chief medical officer and head of R&D.
"Tempest 和 FDA 对于一线肝细胞癌患者中使用 amezalpat 开展关键三期临床试验的所有主要方面普遍达成了共识。本计划中的关键三期研究结果与随机二期研究非常相似，该研究的总体生存期风险比非常有利，随着最新生存期跟进结果的确认，这为关键三期试验的潜在成功带来了信恳智能," Sam Whiting 说，他是 Tempest Therapeutics 的首席医学官兼研发负责人。
Also Read: What's Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
同样阅读： Tempest Therapeutics 在周四股票交易中出现了什么情况?
Key outcomes of the FDA meeting include:
FDA会议的关键结果包括：
- Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints.
- Agreement on the appropriateness of the current amezalpat dose and the Phase 3 study schedule.
- Agreement on the Phase 3 statistical plan, including a pre-specified early efficacy analysis that the company currently estimates, could shorten the time to primary analysis by up to 8 months.
- 就阶段三研究设计而言，包括控制组和主要和次要研究终点达成了共识。
- 就 amezalpat 的现有剂量和阶段三研究时间表的适当性方面达成了共识。
- 就阶段三的统计计划达成了共识，其中包括一个预先指定的早期疗效分析，该公司目前估计会将主要分析时间缩短至多 8 个月。
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting.
计划中的 Phase 3 研究是一个全球性、盲目的、1:1 随机研究，研究对象是一线治疗中的不可切除或转移性 HCC 患者，使用的是 amezalpat 加 atezolizumab 和 bevacizumab，与标准治疗组 atezolizumab 和 bevacizumab 进行比较。
The company is preparing for the Phase 3 study start in the first quarter of 2025.
公司正在为计划中的阶段三研究开始做准备，预计将在 2025 年第一季度开始。
Price Action: TPST stock is up 34.90% at $1.61 at the last check on Thursday.
股票代码 TPSt 在周四最后一次检查时上涨了 34.90%，报价 $1.61。
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