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Kazia Therapeutics Limited

3.09

-0.2100-6.36%

Volume:30.95K

Turnover:94.14K

Market Cap:4.20M

PE:-0.09

High:3.25

Open:3.25

Low:2.90

Close:3.30

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Overview Company News Filings

Sector Update: Health Care Stocks Lower in Afternoon Trading

MT Newswires Live

Why Is Brain Cancer-Focused Kazia Therapeutics Stock Trading Lower On Tuesday?

Kazia Therapeutics Shares Fall After FDA Declines Accelerated Drug Approval

BRIEF-Kazia Therapeutics Provides Update On Paxalisib Regulatory Pathway Following Type C Meeting With FDA

BUZZ-Kazia Therapeutics falls after US FDA says cancer drug cannot be granted accelerated approval

Kazia Therapeutics Shares Drop After FDA Derails Fast Track of Potential Brain Cancer Drug

MT Newswires Live

Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting With FDA

THOMSON REUTERS

Kazia Therapeutics Ltd - FDA Says Os Data Not Appropriate for Accelerated Approval

THOMSON REUTERS

Kazia Therapeutics Ltd - Aligns With FDA on Phase 3 Study Design

THOMSON REUTERS

Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA

Kazia Therapeutics to Present Data Highlighting Synergistic Activity Between Paxalisib and Immunotherapy in Immunotherapy-Resistant Triple Negative Breast Cancer Model at the San Antonio Breast Cancer Symposium

Kazia Therapeutics -Got Letter From Nasdaq Informing Co Has Regained Compliance With Minimum Bid Price Requirement for Continued Listing

THOMSON REUTERS

Kazia Therapeutics Advances Paxalisib with FDA Meeting

BRIEF-Kazia Therapeutics Announces Granting Of Type C Meeting With FDA To Discuss Potential Next Steps For Paxalisib In The Treatment Of Newly Diagnosed Glioblastoma Multiforme

Kazia Therapeutics Announces Granting of Type C Meeting With FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma Multiforme

THOMSON REUTERS

Kazia Therapeutics Ltd - Full Data From Paxalisib Arm Expected Later This Year

THOMSON REUTERS

Kazia Therapeutics Announces Granting of Type C Meeting with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma Multiforme

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Update: Health Care Stocks Lower in Afternoon Trading","url":"https://stock-news.laohu8.com/highlight/detail?id=2500460746","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500460746?lang=en_us&edition=fundamental","pubTime":"2025-01-01 02:51","pubTimestamp":1735671116,"startTime":"0","endTime":"0","summary":"Health care stocks fell Tuesday afternoon with the NYSE Health Care Index down 0.2% and the Health Care Select Sector SPDR Fund  easing 0.1%.The iShares Biotechnology ETF  rose 0.1%.In corporate news, Verastem  shares jumped 46% after the US Food and Drug Administration accepted and granted priority review to a new drug application for its ovarian cancer drug and set an action date of June 30.Kazia Therapeutics  shares fell 37% after the company said it was considering options for its drug candidate paxalisib after the US Food and Drug Administration discouraged an accelerated approval process for the potential glioblastoma treatment.Sangamo Therapeutics  shares sank 55% after it said its partner Pfizer  decided not to proceed with further development of a new gene therapy to treat hemophilia A, a bleeding disorder.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LU0321505439.SGD","BK4534","BK4139","IE0002270589.USD","IE00BLSP4452.SGD","LU1066053197.SGD","LU0225771236.USD","LU1057294990.SGD","LU0868494617.USD","LU0058720904.USD","LU0225284248.USD","BK4585","LU1066051498.USD","VSTM","SG9999003800.SGD","BK4550","IE000M9KFDE8.USD","BK7095","KZIA","LU1883839398.USD","SG9999013999.USD","IE00BBT3K403.USD","IE00B19Z3581.USD","SG9999002232.USD","IBB","LU0306807586.USD","BK4599","LU0985481810.HKD","IE00BLSP4239.USD","LU0122379950.USD","BK4007","BK4588","PFE.AU","BK4592","LU1894683264.USD","SG9999001176.SGD","BK4533","SGXZ57979304.SGD","IE00B19Z3B42.SGD","BK4568","SGMO","XLV","LU0170899867.USD","PFE","SG9999001176.USD","LU0234572021.USD","SG9999002224.SGD","BK4556","LU0321505868.SGD","SG9999011175.SGD"],"gpt_icon":1},{"id":"2500643339","title":"Why Is Brain Cancer-Focused Kazia Therapeutics Stock Trading Lower On Tuesday?","url":"https://stock-news.laohu8.com/highlight/detail?id=2500643339","media":"Benzinga","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500643339?lang=en_us&edition=fundamental","pubTime":"2025-01-01 01:34","pubTimestamp":1735666494,"startTime":"0","endTime":"0","summary":"Kazia Therapeutics Limited  stock is trading lower on Tuesday after the company provided a regulatory update on paxalisib for glioblastoma  following its Type C clinical meeting with the FDA.InJuly 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  compared to standard of care.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.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.“We believe data from the GBM-AGILE trial, including the prespecified secondary endpoint, whic","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/why-brain-cancer-focused-kazia-173454016.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LENZ","KZIA","BK4097","OS","BK4139"],"gpt_icon":0},{"id":"2495616028","title":"Kazia Therapeutics Shares Fall After FDA Declines Accelerated Drug Approval","url":"https://stock-news.laohu8.com/highlight/detail?id=2495616028","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495616028?lang=en_us&edition=fundamental","pubTime":"2024-12-31 23:11","pubTimestamp":1735657860,"startTime":"0","endTime":"0","summary":"Kazia Therapeutics stock retreated Tuesday after the FDA said it could consider standard, but not accelerated, approval for the company's brain cancer drug.Shares of the oncology-focused drug company fell 26% to $2.28 in morning trading. The stock is down about 48% this year.The drug, called paxalisib, is designed to treat the brain cancer glioblastoma. It showed clinically meaningful improvement in overall survival during a July trial, and Kazia's stock more than quadrupled.The FDA said it would generally not approve accelerated approval for pazalisib, Kazia said Tuesday. It could consider support for a standard approval.The FDA said some of the overall survival data would be supportive for designing a pivotal registrational study to pursue standard approval. The agency agreed with Kazia on aspects of a phase 3 study, including patient population and primary endpoint, Kazia said.","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LENZ","BK4139","KZIA"],"gpt_icon":0},{"id":"2495247690","title":"BRIEF-Kazia Therapeutics Provides Update On Paxalisib Regulatory Pathway Following Type C Meeting With FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2495247690","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495247690?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:54","pubTimestamp":1735653293,"startTime":"0","endTime":"0","summary":"BRIEF-Kazia Therapeutics Provides Update On Paxalisib Regulatory Pathway Following Type C Meeting With FDADec 31 (Reuters) - Kazia Therapeutics Ltd KZIA.O:KAZIA THERAPEUTICS PROVIDES UPDATE ON PAXALIS","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241231:nTUA59PWFV:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","KZIA"],"gpt_icon":0},{"id":"2495690902","title":"BUZZ-Kazia Therapeutics falls after US FDA says cancer drug cannot be granted accelerated approval","url":"https://stock-news.laohu8.com/highlight/detail?id=2495690902","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495690902?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:47","pubTimestamp":1735652858,"startTime":"0","endTime":"0","summary":"** Shares of drug developer Kazia Therapeutics     fall 3.2% to $3 premarket    ** KZIA says after discussions, US FDA said data from its mid-to-late stage cancer study \"would generally not be appropriate for accelerated approval, but could be considered to support a standard approval\"    ** Co in July conducted a mid-to-late stage study testing its experimental drug, paxalisib, in patients with glioblastoma- a type of cancer that starts as a growth of cells in the brain    ** Said paxalisib increased survival by 3.8 months in the study vs standard of care in patients with glioblastoma   ** KZIA says it has aligned with FDA on the design of a late-stage study to test the drug    ** Co says it continues to test the drug in pediatric brain cancer and brain metastases as it evaluates its next steps for the drug    ** Up to last close, stock down 29.5% YTD ","market":null,"thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":"BUZZ-Kazia Therapeutics falls after US FDA says cancer drug cannot be granted accelerated approval","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["KZIA","BK4139"],"gpt_icon":0},{"id":"2495690924","title":"Kazia Therapeutics Shares Drop After FDA Derails Fast Track of Potential Brain Cancer Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2495690924","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495690924?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:44","pubTimestamp":1735652666,"startTime":"0","endTime":"0","summary":"Kazia Therapeutics  shares fell more than 6% in pre-market trading Tuesday after the company said it was considering options for its drug candidate paxalisib after the US Food and Drug Administration discouraged an accelerated approval process for the potential glioblastoma treatment.The company said a July study of the drug showed \"clinically meaningful improvement\" for overall survival compared to the standard of care in the treatment of brain cancer. The FDA said the results could be considered to support a standard approval process and aligned with the company on designing a phase 3 study, the company said.The company said it is testing paxalisib for several other indications and will present an outline for a path forward on the drug by the end of January.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4585","KZIA","IE00BFXG0V08.USD","BK4567","IE00B5TLWC47.USD","IE00BYQQ9H92.USD","BK4588","LENZ","BK4139","FAST","BK4104"],"gpt_icon":0},{"id":"2495692558","title":"Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting With FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2495692558","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495692558?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:00","pubTimestamp":1735650003,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241231:nTUA59PWFV:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["KZIA","BK4139"],"gpt_icon":0},{"id":"2495692531","title":"Kazia Therapeutics Ltd - FDA Says Os Data Not Appropriate for Accelerated Approval","url":"https://stock-news.laohu8.com/highlight/detail?id=2495692531","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495692531?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:00","pubTimestamp":1735650003,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241231:nTUA59PWFV:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","KZIA"],"gpt_icon":0},{"id":"2495535692","title":"Kazia Therapeutics Ltd - Aligns With FDA on Phase 3 Study Design","url":"https://stock-news.laohu8.com/highlight/detail?id=2495535692","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495535692?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:00","pubTimestamp":1735650003,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241231:nTUA59PWFV:4","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","KZIA"],"gpt_icon":0},{"id":"2495929676","title":"Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2495929676","media":"PR Newswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495929676?lang=en_us&edition=fundamental","pubTime":"2024-12-31 21:00","pubTimestamp":1735650000,"startTime":"0","endTime":"0","summary":"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  compared to standard of care. 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.\"We appreciate the extensive and thoughtful feedback from the FDA, which provides us with added clarity with respect to paxalisib's potential registration pathway for the treatment of patients with NDU glioblastoma,\" commented Dr. John Friend, Kazia's CEO \"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 pa","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/kazia-therapeutics-provides-paxalisib-regulatory-130000476.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/kazia-therapeutics-provides-paxalisib-regulatory-130000476.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4097","KZIA","LENZ","OS","BK4139"],"gpt_icon":0},{"id":"2490685149","title":"Kazia Therapeutics to Present Data Highlighting Synergistic Activity Between Paxalisib and Immunotherapy in Immunotherapy-Resistant Triple Negative Breast Cancer Model at the San Antonio Breast Cancer Symposium","url":"https://stock-news.laohu8.com/highlight/detail?id=2490685149","media":"PR Newswire","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2490685149?lang=en_us&edition=fundamental","pubTime":"2024-12-11 21:00","pubTimestamp":1733922000,"startTime":"0","endTime":"0","summary":"SYDNEY, Dec. 11, 2024 /PRNewswire/ -- Kazia Therapeutics Limited , an oncology-focused drug development, announced that data from two abstracts will be presented at the San Antonio Breast Cancer Symposium highlighting the activity the Company's lead product candidate, paxalisib, for the potential treatment of immunotherapy-resistant triple negative breast cancer  and HER2 positive metastatic breast cancer with active brain metastases.\"In a second abstract, clinical investigators presented efficacy and safety data in heavily pretreated patients  with HER2 positive breast cancer with active brain metastases. Although the primary endpoint of overall response rate  was not met, patients receiving a combination of paxalisib and trastuzumab  had a median overall survival of 16.5 months, which compares favorably versus historical control studies.\"","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/7d1Pp00nd36xGLybjR7CaQ--~B/aD0xNTA7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/a0db042be43a53b84547568a8e78101c","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/7d1Pp00nd36xGLybjR7CaQ--~B/aD0xNTA7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/a0db042be43a53b84547568a8e78101c"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/kazia-therapeutics-present-data-highlighting-130000183.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/kazia-therapeutics-present-data-highlighting-130000183.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["KZIA","LENZ","BK4139"],"gpt_icon":0},{"id":"2482081849","title":"Kazia Therapeutics -Got Letter From Nasdaq Informing Co Has Regained Compliance With Minimum Bid Price Requirement for Continued Listing","url":"https://stock-news.laohu8.com/highlight/detail?id=2482081849","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2482081849?lang=en_us&edition=fundamental","pubTime":"2024-11-12 23:09","pubTimestamp":1731424173,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241112:nFWN3MJ1JK:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","KZIA"],"gpt_icon":0},{"id":"2481658985","title":"Kazia Therapeutics Advances Paxalisib with FDA Meeting","url":"https://stock-news.laohu8.com/highlight/detail?id=2481658985","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2481658985?lang=en_us&edition=fundamental","pubTime":"2024-11-05 05:59","pubTimestamp":1730757571,"startTime":"0","endTime":"0","summary":"Kazia Therapeutics (KZIA) has released an update. 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Company updates to corporate presentation and participation in upcoming medical meetings. SYDNEY, Nov. 4, 2024 /PRNewswire/ -- Kazia Therapeutics Limited , an oncology-focused drug development company, announced that the U.S. Food and Drug Administration  has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia's blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM.In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. 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