Core Viewpoint - Kazia Therapeutics Limited is advancing its investigational drug paxalisib for glioblastoma multiforme (GBM) and is set to meet with the FDA in December 2024 to discuss registration pathways [1][3]. Company Updates - The company announced results from the Phase II/III clinical trial GBM-AGILE, indicating clinically meaningful improvement in overall survival for newly diagnosed unmethylated GBM patients treated with paxalisib [2]. - Kazia has updated its corporate presentation to include preliminary data from the GBM-AGILE trial, which compares paxalisib to standard care for glioblastoma treatment [4]. - The company plans to participate in several medical conferences in Q4 2024, including the Society for Neuro-Oncology Annual Meeting and the San Antonio Breast Cancer Symposium, to engage with stakeholders and discuss investment opportunities [5][6]. Drug Development and Designations - Paxalisib has received orphan drug designation and fast track designation from the FDA for treating glioblastoma in patients with unmethylated MGMT promoter status, following radiation and temozolomide therapy [3][8]. - The drug has been involved in ten clinical trials since its licensing from Genentech in late 2016, with ongoing studies in various brain cancer types [7][8]. Future Plans - Full data from the GBM-AGILE study, including secondary endpoints, is expected to be presented at a scientific meeting later in 2024 [2]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, with promising preclinical data indicating activity against a broad range of tumor types [8].

SYDNEY, Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncologyfocused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination). Under t ...

Core Viewpoint - Kazia Therapeutics is a biotechnology company focused on developing oncology drugs, particularly paxalisib for glioblastoma, which has shown promising clinical trial results [2][8]. Group 1: Company Overview - Kazia Therapeutics is an Australian biotechnology firm specializing in oncology drug development [2]. - The company's primary drug in development is paxalisib, which recently completed a phase II/III study for glioblastoma treatment [2]. Group 2: Clinical Trial Results - Paxalisib demonstrated a 3.8-month improvement in overall survival, representing an approximate 33% improvement for selected glioblastoma patients compared to the standard of care [8]. - The drug was well tolerated during the study, marking significant progress for Kazia Therapeutics [8]. Group 3: Stock Performance - Kazia Therapeutics' stock price surged from $0.20 to a 52-week high of $1.58 before dropping to $0.53 [3]. - The volatility in stock price reflects the unpredictable nature of biotech investments [5][7]. Group 4: Future Prospects - Kazia Therapeutics plans to release full data from the paxalisib study at a scientific meeting later this year, which could influence future stock performance [9]. - The company intends to meet with the U.S. FDA to discuss the results and explore a potential path to accelerated approval for paxalisib [10].

Core Viewpoint - Kazia Therapeutics has reported significant positive data from its phase II/III study of paxalisib for glioblastoma, leading to a substantial increase in its stock price and plans for potential FDA accelerated approval [4][3]. Company Overview - Kazia Therapeutics is an Australia-based clinical-stage company focused on developing drugs for oncology indications [1]. Study Results - The recent study showed that paxalisib-treated patients had a median overall survival (OS) of 15.7 months compared to 12.7 months for those receiving standard chemotherapy [2]. - In a secondary analysis, newly diagnosed unmethylated (NDU) patients treated with paxalisib achieved a median OS of 15.54 months, representing a 3.8-month improvement (nearly 33%) over the control group [5][10]. - The primary analysis indicated a median OS of 14.77 months for paxalisib in NDU patients, which was slightly better than the 13.84 months for the standard of care [15]. Stock Performance - Kazia's shares have surged 489.6% in the past week following the positive study results, and have increased 182.2% year to date, contrasting with a 5.1% decline in the industry [4][13]. Future Plans - The company plans to request a meeting with the FDA to explore a potential pathway for accelerated approval of paxalisib [3]. Study Context - The GBM AGILE study, which evaluates multiple therapies for glioblastoma, has completed enrollment for paxalisib, making it the third drug to do so [16].

The Kazia Therapeutics clinical trial covered the company's paxalisib as a treatment of glioblastoma. Results from the trial came out positive when compared to the standard of care (SOC). The big news was the increase in the median Overall Survival (OS) period to 14.77 months. For the record, the SOC median OS rate is 13.84 months. A secondary analysis also showed a median OS of 15.54 months. KZIA Stock Movement Today The rally for KZIA stock isn't over yet with the company's shares up another 51.3% as of T ...

Kazia Therapeutics (NASDAQ:KZIA) stock is soaring higher on Wednesday after the oncology-focused biotechnology company provided results from a Phase II/III clinical trial. These results concern the effectiveness of paxalisib as a treatment of glioblastoma versus the standard of care (SOC). That includes a median Overall Survival (OS) period of 14.77 months for patients treated with paxalisib. For comparison, the SOC survival rate is 13.84 months. Median OS in its prespecified secondary analysis came in at 1 ...

Core Insights - Kazia Therapeutics Limited announced results from the GBM-AGILE study, highlighting the efficacy of paxalisib in treating glioblastoma, a severe brain cancer with significant unmet medical needs [1][9]. Study Overview - The GBM-AGILE trial is an adaptive phase II/III global study sponsored by the Global Coalition for Adaptive Research, aimed at evaluating the response of glioblastoma patients to new investigational agents using innovative Bayesian design [2]. - The trial included 313 patients, with newly diagnosed unmethylated (NDU) and recurrent glioblastoma patients randomized to receive either paxalisib or standard of care [3]. Efficacy Results - In the primary analysis, the median overall survival (OS) for paxalisib-treated NDU patients was 14.77 months compared to 13.84 months for the cumulative standard of care [10]. - A prespecified secondary analysis showed a median OS of 15.54 months for paxalisib-treated NDU patients versus 11.89 months for concurrent standard of care, indicating a 3.8-month improvement, approximately a 33% increase in survival [10][19]. - No efficacy signal was detected in the recurrent disease population, with median OS of 9.69 months for standard of care versus 8.05 months for paxalisib [5]. Safety Profile - Paxalisib was well tolerated in the GBM-AGILE trial, with no new safety signals identified in the patient population [11]. Future Plans - Based on the data from the GBM-AGILE study, Kazia plans to request a meeting with the FDA to discuss potential pathways for accelerated approval of paxalisib [12]. - Full data, including secondary endpoints from the paxalisib arm, is expected to be presented at a scientific meeting later in 2024 [18]. Company Background - Kazia Therapeutics is focused on developing paxalisib, an investigational drug targeting the PI3K/Akt/mTOR pathway for various brain cancers, and has conducted multiple clinical trials since its licensing from Genentech in 2016 [6]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, with ongoing Phase I studies [7].

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SYDNEY, May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia Therapeutics, the SRT has reviewed all preliminary (non-final) safety and pharm ...

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