By Katherine Hamilton
Kazia Therapeutics stock retreated Tuesday after the FDA said it could consider standard, but not accelerated, approval for the company's brain cancer drug.
Shares of the oncology-focused drug company fell 26% to $2.28 in morning trading. The stock is down about 48% this year.
The drug, called paxalisib, is designed to treat the brain cancer glioblastoma. It showed clinically meaningful improvement in overall survival during a July trial, and Kazia's stock more than quadrupled.
The FDA said it would generally not approve accelerated approval for pazalisib, Kazia said Tuesday. It could consider support for a standard approval.
The FDA said some of the overall survival data would be supportive for designing a pivotal registrational study to pursue standard approval. The agency agreed with Kazia on aspects of a phase 3 study, including patient population and primary endpoint, Kazia said.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
December 31, 2024 10:11 ET (15:11 GMT)
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