Kazia Therapeutics (KZIA) announced that the U.S. FDA has granted a Type C meeting with the company in December to discuss the potential pathways to registration of Kazia’s blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM. In July, the company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data including secondary endpoints from the paxalisib arm of the GBM-AGILE study is expected to be presented at a scientific meeting later this year. Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See today’s best-performing stocks on TipRanks >>
Read More on KZIA:
- Upcoming Stock Splits This Week (October 28 to November 1) – Stay Invested
- Kazia Therapeutics trading halted, news pending
- Kazia Therapeutics Adjusts ADS Ratio to Boost Nasdaq Listing
- Kazia Therapeutics Reveals Promising Brain Cancer Study
- Kazia Therapeutics announces presentation of Phase 1 data on paxalisib
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
