Kazia Therapeutics Shares Higher Premarket on Key FDA Designation

By Colin Kellaher

U.S.-listed shares of Kazia Therapeutics jumped in premarket trading Thursday after the Australian biotechnology company said the U.S. Food and Drug Administration granted a second fast-track designation to its lead program, paxalisib, in certain brain-cancer patients.

The Sydney-based company said the latest designation covers paxalisib for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Kazia previously won FDA fast-track designation for paxalisib in glioblastoma, an aggressive type of brain tumor, in August 2020.

Kazia's U.S.-listed shares, which closed Wednesday at $1.17, were recently up nearly 26% to $1.47 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 06, 2023 07:36 ET (11:36 GMT)

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