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).
週四，Tempest Therapeutics Inc. (NASDAQ: TPST) 宣佈其關於一線不可切除或轉移性肝細胞癌（HCC）治療中 TPSt-1120 與 atezolizumab 和 bevacizumab 的結局二期會議與 FDA 的反饋。
Roche Holding AG's (OTC:RHHBY) Genentech sells bevacizumab as Avastin and atezolizumab as Tecentriq.
羅氏（OTC: RHHBY）的子公司 Genentech 將 bevacizumab 命名爲 Avastin，而 atezolizumab 命名爲 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 對於一線肝細胞癌患者中使用 amezalpat 開展關鍵三期臨床試驗的所有主要方面普遍達成了共識。本計劃中的關鍵三期研究結果與隨機二期研究非常相似，該研究的總體生存期風險比非常有利，隨着最新生存期跟進結果的確認，這爲關鍵三期試驗的潛在成功帶來了信懇智能," Sam Whiting 說，他是 Tempest Therapeutics 的首席醫學官兼研發負責人。
Also Read: What's Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
同樣閱讀： Tempest Therapeutics 在週四股票交易中出現了什麼情況?
Key outcomes of the FDA meeting include:
FDA會議的關鍵結果包括：
- 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.
- 就階段三研究設計而言，包括控制組和主要和次要研究終點達成了共識。
- 就 amezalpat 的現有劑量和階段三研究時間表的適當性方面達成了共識。
- 就階段三的統計計劃達成了共識，其中包括一個預先指定的早期療效分析，該公司目前估計會將主要分析時間縮短至多 8 個月。
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.
計劃中的 Phase 3 研究是一個全球性、盲目的、1:1 隨機研究，研究對象是一線治療中的不可切除或轉移性 HCC 患者，使用的是 amezalpat 加 atezolizumab 和 bevacizumab，與標準治療組 atezolizumab 和 bevacizumab 進行比較。
The company is preparing for the Phase 3 study start in the first quarter of 2025.
公司正在爲計劃中的階段三研究開始做準備，預計將在 2025 年第一季度開始。
Price Action: TPST stock is up 34.90% at $1.61 at the last check on Thursday.
股票代碼 TPSt 在週四最後一次檢查時上漲了 34.90%，報價 $1.61。
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譯文內容由第三人軟體翻譯。