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 Limited - American Depositary Shares (KZIA)
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kaziatherapeutics.com
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Source: PR Newswire
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. Full data including secondary endpoints from the paxalisib arm of the GBM-AG
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News
- 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 [Yahoo! Finance]Yahoo! Finance
- 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 SymposiumPR Newswire
- Kazia Therapeutics Announces Presentation of Promising Phase I Data Evaluating Concurrent Paxalisib and Radiation Therapy in Patients with Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations at the American Society fPR Newswire
- Kazia Therapeutics Announces Presentation of EVT801 Clinical Data at 15th Biennial Ovarian Cancer Research SymposiumPR Newswire
KZIA
Sec Filings
- 12/11/24 - Form 424B3
- 12/11/24 - Form 424B3
- 12/11/24 - Form 6-K
- KZIA's page on the SEC website