Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA [Yahoo! Finance]
Kazia Therapeutics Limited - American Depositary Shares (KZIA)
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kaziatherapeutics.com
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Source: Yahoo! Finance
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). Kazia Therapeutics Limited Logo (PRNewsfoto/Kazia Therapeutics Limited) 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. Based on these results and the totality of data from all completed paxalisib clinical studies, Kazia requested a meeting with the FDA to discuss potential clinical and regulatory paths forward. Following discussions with the FDA and feedback from Kazia's recent Type C meeting, the FDA's current position is that data on OS would generally not be appropriate for accelerated approval, but could be consi
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News
- Why Is Brain Cancer-Focused Kazia Therapeutics Stock Trading Lower On Tuesday? [Yahoo! Finance]Yahoo! Finance
- Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDAPR Newswire
- 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 Granting of Type C Meeting with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma MultiformePR Newswire
KZIA
Sec Filings
- 12/31/24 - Form 424B3
- 12/31/24 - Form 424B3
- 12/31/24 - Form 6-K
- KZIA's page on the SEC website