Kazia Therapeutics (KZIA) shares fell more than 6% in pre-market trading Tuesday after the company said it was considering options for its drug candidate paxalisib after the US Food and Drug Administration discouraged an accelerated approval process for the potential glioblastoma treatment.
The company said a July study of the drug showed "clinically meaningful improvement" for overall survival compared to the standard of care in the treatment of brain cancer. The FDA said the results could be considered to support a standard approval process and aligned with the company on designing a phase 3 study, the company said.
The company said it is testing paxalisib for several other indications and will present an outline for a path forward on the drug by the end of January.
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