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Kazia Therapeutics Shares Rise Premarket After Key FDA Designation

By Colin Kellaher

 

U.S.-listed shares of Kazia Therapeutics Ltd. jumped more than 15% in premarket trading Wednesday after the Australian biotechnology company said the U.S. Food and Drug Administration awarded rare-pediatric-disease designation to its lead program in a rare and highly-aggressive childhood brain cancer.

Kazia said the designation covers paxalisib for the treatment of atypical rhabdoid/teratoid tumors, fast-growing tumors that begin in the brain and spinal cord and usually occur in children ages 3 and under.

The FDA's rare-pediatric-disease designation covers diseases with serious or life-threatening manifestations that mainly affect fewer than 200,000 people in the U.S. under the age of 18.

The agency awards priority-review vouchers to drug makers upon approval of drugs that are granted the designation, and those vouchers can be used to obtain priority review for another drug or sold to other companies.

Kazia's U.S. shares, which closed Tuesday at $4.17, were recently up 16% to $4.84 in premarket trading.

 

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

 

(END) Dow Jones Newswires

July 06, 2022 07:37 ET (11:37 GMT)

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