Kazia Therapeutics Ltd KZIA shares are trading higher Thursday after the company announced it received FDA Fast Track Designation for its lead program paxalisib.
What Happened: The FDA granted Kazia's paxalisib Fast Track Designation for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.
The Fast Track Designation was based on clinical data from an interim analysis of an ongoing Phase 1 clinical trial in which patients with brain metastases from a primary tumor are receiving paxalisib in combination with radiotherapy. 100% of evaluable patients in the trial responded to the combination of paxalisib with radiotherapy.
"We have seen a high level of interest from clinicians in the emerging data from this patient population, and it is exciting to now have that interest complemented by FDA's award of Fast Track Designation," said John Friend, CEO of Kazia.
Further data from the ongoing Phase 1 study is expected in the first quarter of 2024. Paxalisib is also the subject of nine other ongoing clinical trials.
See Also: Why Allarity Therapeutics Stock Is Tanking Today
KZIA Price Action: Kazia shares were up 8.55% at $1.27 at the time of writing, per Benzinga Pro.
Photo: Lalmch from Pixabay.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.