Kazia Therapeutics to Request FDA Type C Meeting to Discuss Overall Survival Data in GBM and Potential NDA Filing in Alignment with FDA initiative Project FrontRunner
Kazia Therapeutics Limited - American Depositary Shares (KZIA)
US:NASDAQ Investor Relations:
kaziatherapeutics.com
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Source: PR Newswire
SYDNEY, Oct. 27, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") today announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall survival (OS) findings in newly diagnosed glioblastoma (GBM) patients treated with paxalisib and to seek agency feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative. "GBM remains one of the most lethal cancers with limited therapeutic options. In line with the FDA Oncology Center of Excellence's Project FrontRunner initiative, we intend to engage the Agency to discuss whether the overall survival data generated in newly diagnosed GBM patients treated with paxalisib may be adequate to support a conditional approval pathway," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "Consistent with this framework, Kaz
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News
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- Kazia Therapeutics Achieves Initial iCR (Immune-Complete Response) in Metastatic TNBC and Delivers Q4 Business Update with Breakthroughs Across Breast Cancer, Immuno-Oncology, and GBM Regulatory StrategyPR Newswire
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KZIA
Analyst Actions
- 10/2/25 - Maxim Group
KZIA
Sec Filings
- 12/5/25 - Form 6-K
- 12/2/25 - Form 6-K
- 11/18/25 - Form 424B3
- KZIA's page on the SEC website