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Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
KZIA
prnewswire.comDecember 31, 2024

SYDNEY , Dec. 31, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA). In July 2024, the Company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated (NDU) 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.

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
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
KZIA
prnewswire.comNovember 4, 2024

Company and FDA to meet in December to discuss potential pathways to registration of paxalisib in glioblastoma multiforme (GBM) Company updates to corporate presentation and participation in upcoming medical meetings SYDNEY , Nov. 4, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, announced that the U.S. Food and Drug Administration (FDA) 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.

KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER
KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER
KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER
KZIA
prnewswire.comSeptember 12, 2024

SYDNEY , Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused 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).

Biotech Stock Laboratory: Try a Small Experiment With Kazia Therapeutics
Biotech Stock Laboratory: Try a Small Experiment With Kazia Therapeutics
Biotech Stock Laboratory: Try a Small Experiment With Kazia Therapeutics
KZIA
investorplace.comJuly 25, 2024

Biotechnology stock traders, listen up! Do you like to roll the dice and take your chances on promising drug developers?

Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
KZIA
zacks.comJuly 12, 2024

Kazia (KZIA) surges after positive data from a phase II/III study on its lead pipeline drug in patients with glioblastoma. Based on this data, it plans to seek an accelerated nod from the FDA.

KZIA Stock Alert: Kazia Continues Its Surge on Thursday With 51% Gains
KZIA Stock Alert: Kazia Continues Its Surge on Thursday With 51% Gains
KZIA Stock Alert: Kazia Continues Its Surge on Thursday With 51% Gains
KZIA
investorplace.comJuly 11, 2024

Kazia Therapeutics (NASDAQ: KZIA ) stock is continuing to rally on Thursday after the company reported positive alongside clinical trial data yesterday. The Kazia Therapeutics clinical trial covered the company's paxalisib as a treatment of glioblastoma.

Why Is Kazia Therapeutics (KZIA) Stock Up 300% Today?
Why Is Kazia Therapeutics (KZIA) Stock Up 300% Today?
Why Is Kazia Therapeutics (KZIA) Stock Up 300% Today?
KZIA
investorplace.comJuly 10, 2024

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).

Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma
Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma
Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma
KZIA
prnewswire.comJuly 10, 2024

GBM AGILE trial data shows clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma SYDNEY , July 10, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics.  GBM AGILE STUDY GBM AGILE is an adaptive phase II/III global trial sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world's foremost clinical, translational, and basic science researchers, from institutions such as Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute.

KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS AT ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER
KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS AT ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER
KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS AT ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER
KZIA
prnewswire.comJune 27, 2024

SYDNEY , June 27, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data from its lead program, paxalisib, at the upcoming 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) June 29 – July 2, 2024, in Philadelphia, PA. Kazia concurrently announces  publication of an article in European Journal of Cancer highlighting the need for evaluating mutation-specific, CNS penetrant, inhibitors to treat pediatric patients with Diffuse Midline Glioma (DMG).