Kazia Therapeutics Limited (NASDAQ:KZIA) stock is trading lower on Tuesday after the company provided a regulatory update on paxalisib for glioblastoma (GBM) following its Type C clinical meeting with the FDA.
In July 2024, the company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated 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 overall survival would generally not be appropriate for accelerated approval but could be considered to support a traditional/standard approval.
The agency further commented that the secondary endpoint overall survival data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval.
Importantly, the company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used.
“We believe data from the GBM-AGILE trial, including the prespecified secondary endpoint, which demonstrated a 3.8-month OS improvement, provides evidence supporting a clinically meaningful efficacy signal that merits further testing paxalisib in this patient population in a larger, pivotal study,” commented Dr. John Friend, Kazia’s CEO.
The company said it is continuing to evaluate several options, and we expect to provide an outline for a path forward to maximize shareholder value by the end of January 2025.
Price Action: KZIA stock is down 40.30% at $1.85 at the last check on Tuesday.
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