Tonpor Kasa
Kazia Therapeutics (NASDAQ:KZIA) stock soared 142% in morning trading Wednesday after the company reported positive Phase 2/3 results for its drug paxalisib in the treatment of glioblastoma.
A primary analysis of the study, called GBM-AGILE, showed a median overall survival of 14.77 months for paxalisib treated patients versus 13.84 months for those given standard of care. A total of 313 newly diagnosed unmethylated, or NDU, patients and recurrent patients took part in the study.
The company said a prespecified secondary analysis in NDU patients showed a median overall survival of 15.54 months in the paxalisib arm, compared with 11.89 months for those undergoing concurrent standard of care.
Kazia said that it intends to request a meeting with the FDA to determine if an accelerated pathway for approval is appropriate for the product.