Kazia Therapeutics falls after US FDA says cancer drug cannot be granted accelerated approval

Kazia Therapeutics

31/12/2024 13:47

** Shares of drug developer Kazia Therapeutics  KZIA.O 
 RIC  fall 3.2% to $3 premarket 
    ** KZIA says after discussions, US FDA said data from its
mid-to-late stage cancer study "would generally not be
appropriate for accelerated approval, but could be considered to
support a standard approval" 
    ** Co in July conducted a mid-to-late stage study testing
its experimental drug, paxalisib, in patients with glioblastoma-
a type of cancer that starts as a growth of cells in the brain 
    ** Said paxalisib increased survival by 3.8 months in the
study vs standard of care in patients with glioblastoma
    ** KZIA says it has aligned with FDA on the design of a
late-stage study to test the drug 
    ** Co says it continues to test the drug in pediatric brain
cancer and brain metastases as it evaluates its next steps for
the drug 
    ** Up to last close, stock down 29.5% YTD

 (Reporting by Sneha S K)
 ((Sneha.SK@thomsonreuters.com;))