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Thursday, August 20, 2020

Kazia Therapeutics up on U.S. accelerated review tag for lead drug

Nano cap Kazia Therapeutics Limited (NASDAQ:KZIA) jumps 21% premarket on robust volume in reaction to Fast Track status in the U.S. for lead drug paxalisib for a type of brain cancer called glioblastoma.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Shares rallied in April when it reported positive preliminary data from a mid-stage study. Additional data should be available this year with final results expected in H1 2021.

Paxalisib, in-licensed from Roche in 2016, modulates an intracellular pathway called PI3K that plays a key role in cell growth, proliferation, survival and angiogenesis (growth of blood vessels).


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