Australia-based drug development company Kazia Therapeutics Limited (NASDAQ: KZIA) announced on Monday that it has been granted a Type C meeting with the U.S. FDA in December 2024 to discuss potential registration pathways for paxalisib, its PI3K/mTOR inhibitor for treating newly diagnosed glioblastoma multiforme (GBM).

Kazia's paxalisib, which crosses the blood-brain barrier, showed promising results in a Phase II/III trial (GBM-AGILE), with improved overall survival for unmethylated GBM patients.

The company's corporate presentation now includes preliminary trial data from GBM-AGILE, accessible on Kazia's website. Kazia will also participate in the Society for Neuro-Oncology Annual Meeting and the San Antonio Breast Cancer Symposium later this year, offering opportunities to engage with investors and stakeholders.

Paxalisib holds Orphan Drug and Fast Track Designations from the FDA for glioblastoma and other rare CNS cancers. Kazia is also advancing EVT801, a VEGFR3 inhibitor, in clinical trials following successful preclinical outcomes, with data presented at the Ovarian Cancer Research Symposium in September 2024.