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].

Table of Contents As filed with the Securities and Exchange Commission on June 24, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification N ...

Table of Contents (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on May 29, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (I.R.S. Employer Identification No ...

If at any time during the Second Compliance Period the closing bid price of the Company's security is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance. Nasdaq's determination was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and th ...

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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (Exact name of Registrant as specified in its charter) As filed with the Securities and Exchange Commission on January 30, 2024 (State or other jurisdiction of incorporation or organization) Registration No. 333- Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificatio ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCH ...