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SYDNEY - Kazia Therapeutics Limited (NASDAQ:KZIA), a small-cap biotech company with a market capitalization of $7.8 million, announced Monday it plans to request a follow-up Type C meeting with the U.S. Food and Drug Administration to discuss overall survival data for its brain cancer drug paxalisib and explore a potential regulatory pathway. According to InvestingPro data, the company maintains a favorable position with more cash than debt on its balance sheet, providing financial flexibility for its drug development programs.
The company aims to align its approach with the FDA’s Project FrontRunner initiative, which encourages developing cancer treatments for earlier clinical settings rather than only for patients who have exhausted other options.
Kazia reported that in a prespecified secondary analysis of newly diagnosed unmethylated glioblastoma patients, those receiving paxalisib showed a median overall survival of 15.54 months compared to 11.89 months for patients on standard care. While the clinical results appear promising, InvestingPro analysis indicates the company’s overall financial health score remains weak at 1.64, though analysts have set price targets significantly above current trading levels.
"GBM remains one of the most lethal cancers with limited therapeutic options," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics. "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."
The company plans to propose initiating a post-approval, randomized Phase 3 confirmatory study before submitting a New Drug Application, citing the FDA’s recent emphasis on overall survival as the primary endpoint for cancer treatments, particularly in diseases with short natural history.
Glioblastoma is an aggressive form of brain cancer with few effective treatment options. Paxalisib is an investigational brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway that has received multiple FDA designations, including Orphan Drug Designation for glioblastoma and Fast Track Designation.
The announcement was made in a press release statement issued by the company. Despite experiencing significant stock price volatility, with shares down over 70% in the past year but up 92% over the last six months, InvestingPro analysis suggests the stock may be undervalued at current levels. Subscribers can access additional insights, including 8 more ProTips and detailed financial metrics, to better evaluate the company’s potential.
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