Kazia Therapeuti Stock Price, News & Analysis

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) shared new data on its drug paxalisib at the Society for Neuro-Oncology (SNO) Annual Meeting. The interim analysis of the phase II glioblastoma study indicated a median progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months, significantly outperforming the standard treatment, temozolomide (PFS: 5.3 months, OS: 12.7 months). The safety profile at a 60mg dose is also consistent with earlier findings. A separate study on pediatric patients showed promising tolerability and pharmacokinetics.

Kazia Therapeutics (NASDAQ: KZIA) has entered a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to join the GBM AGILE pivotal study for glioblastoma. This collaboration will initiate the operational phase of the study, targeting the recruitment of patients for the paxalisib arm, expected to begin in Q1 CY2021. Kazia will pay an initial fee of US$ 5 million to GCAR, with additional milestone payments throughout the study. The GBM AGILE study aims to provide essential clinical evidence for the regulatory approval of paxalisib in key markets.

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) has partnered with Dana-Farber Cancer Institute to explore the use of its drug paxalisib in treating primary CNS lymphoma. This collaboration includes a phase II clinical trial to recruit up to 25 patients, expected to last two years. Paxalisib, a PI3K inhibitor, is the only one in development capable of crossing the blood-brain barrier, targeting a disease that has limited treatment options. Kazia will provide the study drug and financial support from its recent Share Purchase Plan.

Kazia Therapeutics (NASDAQ:KZIA) is reinitiating its focus on paxalisib, a PI3K inhibitor for treating glioblastoma multiforme (GBM). This drug will enter the innovative GBM AGILE study with patient enrollment expected by the end of 2020. The valuation for Kazia has been set at US$104 million (A$145 million) with a target price of US$10.98 per ADR. Forecasts indicate a peak sales potential of US$450 million, though approximately US$32 million (A$45 million) in capital is needed to reach approval by 2025.

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) has received Orphan Drug Designation (ODD) from the US FDA for paxalisib, aimed at treating malignant glioma, including the aggressive childhood cancer DIPG. This designation, following the Rare Pediatric Disease Designation received on August 7, 2020, provides several incentives such as up to seven years of exclusivity and potential grant funding. CEO Dr. James Garner emphasized that these approvals will expedite paxalisib's commercialization and development processes, with initial efficacy data expected in late 2020.

Kazia Therapeutics Limited (KZIA) has received Orphan Drug Designation (ODD) from the FDA for its drug paxalisib, targeting malignant glioma, including Diffuse Intrinsic Pontine Glioma (DIPG), a critical childhood brain cancer. This designation follows the Rare Pediatric Disease Designation awarded earlier in August 2020. ODD grants up to seven years of exclusivity and financial benefits, including fee waivers for new applications. Initial data from a phase I study in DIPG is anticipated in the latter half of 2020, with further data on glioblastoma expected at an upcoming conference.

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) announced that the U.S. FDA granted Fast Track Designation to its drug paxalisib for treating glioblastoma, a severe brain cancer. This designation enhances Kazia's access to the FDA, enabling expedited drug development and potential faster approval processes. Paxalisib is intended for newly diagnosed glioblastoma patients with specific genetic markers, building on favorable interim results from a phase II trial showing a median overall survival of 17.7 months. The company plans to initiate NDA preparations in CY2021.

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) has received Rare Pediatric Disease Designation (RPDD) from the FDA for its drug paxalisib, aimed at treating Diffuse Intrinsic Pontine Glioma (DIPG), a rare childhood brain cancer. This designation may enable Kazia to obtain a priority review voucher, valued between US$68 million and US$350 million, if paxalisib receives approval for DIPG. Positive preclinical data has been reported, with initial efficacy results expected in the second half of 2020. Currently, there are no FDA-approved treatments for DIPG, with a typical survival time of around 9.5 months.

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) presented interim data at the AACR Annual Meeting, showcasing promising results for paxalisib in glioblastoma and Cantrixil in ovarian cancer. The phase II study of paxalisib, now with data on 30 patients, showed a progression-free survival (PFS) of 8.5 months and overall survival (OS) of 17.7 months. In the Cantrixil study, one complete response and two partial responses were noted, leading to an overall response rate of 19%. The company plans to commence pivotal studies for paxalisib in late 2020.