Why Is Brain Cancer-Focused Kazia Therapeutics Stock Trading Lower On Tuesday?
Why Is Brain Cancer-Focused Kazia Therapeutics Stock Trading Lower On Tuesday?
Following discussions with the FDA and feedback from Kazia's recent Type C meeting, the FDA's current position is that data on overall survival would generally not be appropriate for accelerated approval but could be considered to support a traditional/standard approval.Kazia Therapeutics Limited (NASDAQ:KZIA) stock is trading lower on Tuesday after the company provided a regulatory update on paxalisib for glioblastoma (GBM) following its Type C clinical meeting with the FDA.
Kazia Therapeutics Limited (納斯達克:KZIA) 股票在週二下跌，此前該公司就其與FDA舉行的Type C臨牀會議後，提供了關於paxalisib治療膠質母細胞瘤（GBM）的監管更新。
In July 2024, the company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed a clinically meaningful improvement in a prespecified secondary analysis for overall survival (OS) compared to standard of care.
2024年7月，該公司報告了GBm-AGILE研究的頂線結果，研究顯示，新診斷的未甲基化膠質母細胞瘤患者在接受paxalisib治療後，在預先指定的次要分析中，整體生存期（OS）相較於標準治療有臨牀上顯著的改善。
Based on these results and the totality of data from all completed paxalisib clinical studies, Kazia requested a meeting with the FDA to discuss potential clinical and regulatory paths forward.
基於這些結果以及所有已完成的paxalisib臨牀研究的數據總和，Kazia請求與FDA舉行會議，討論未來潛在的臨牀和監管路徑。
Following discussions with the FDA and feedback from Kazia's recent Type C meeting, the FDA's current position is that data on overall survival would generally not be appropriate for accelerated approval but could be considered to support a traditional/standard approval.
根據與FDA的討論以及Kazia最近Type C會議的反饋，FDA目前的立場是，整體生存期的數據通常不適合用於加速批准，但可以考慮作爲傳統/標準批准的支持依據。
The agency further commented that the secondary endpoint overall survival data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval.
該機構進一步評論稱，來自GBm-AGILE研究的次要終點整體生存期數據對於設計和實施追求標準批准的關鍵註冊研究是支持和有信息量的。
Importantly, the company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used.
重要的是，該公司與FDA在擬議的註冊/關鍵3期研究設計的關鍵方面達成了一致，包括患者人群、主要終點和將使用的比較組。
"We believe data from the GBM-AGILE trial, including the prespecified secondary endpoint, which demonstrated a 3.8-month OS improvement, provides evidence supporting a clinically meaningful efficacy signal that merits further testing paxalisib in this patient population in a larger, pivotal study," commented Dr. John Friend, Kazia's CEO.
Kazia的首席執行官約翰·弗蘭德博士評論稱："我們相信，來自GBm-AGILE試驗的數據，包括預先指定的次要終點，顯示了3.8個月的OS改善，提供了支持在這一患者群體中進一步測試paxalisib的臨牀意義有效信號的證據，這需要進行更大的關鍵研究。"
The company said it is continuing to evaluate several options, and we expect to provide an outline for a path forward to maximize shareholder value by the end of January 2025.
該公司表示，正在繼續評估多個選項，並預計在2025年1月底之前提供一條旨在最大化股東價值的發展路線。
Price Action: KZIA stock is down 40.30% at $1.85 at the last check on Tuesday.
價格走勢：KZIA股票在上週二的最後一次檢查中下跌了40.30%，當前價格爲1.85美元。
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