Kazia Therapeutics (NASDAQ:KZIA) stock is on the move Thursday after the company received fast-track designation for its paxalisib program.
The Food and Drug Administration (FDA) granted the drug fast-track designation as it’s designed to treat solid tumor brain metastases harboring PI3K pathway mutations. The company seeks to use the drug alongside radiation therapy.
According to Kazia Therapeutics, it was granted this designation after the FDA saw interim data from its Phase 1 clinical trial of the drug. The positive results from this data have the FDA hopeful that paxalisib could be a candidate to treat solid tumor brain metastases.
Dr. John Friend, CEO of Kazia Therapeutics, said the following about the news:
“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. With important data read-outs expected in adult and childhood brain cancer during CY2023, we will be working with investigators and advisors to drive forward our research in brain metastases also.”
What This Means For KZIA Stock
Fast track designation will allow Kazia Therapeutics certain advantages when developing paxalisib. That includes more frequent meetings with the FDA as well as the potential for accelerated approval.
All of that means that Kazia Therapeutics could see paxalisib hit the commercial market sooner than if it didn’t have the fast-track designation. That could allow for quicker earnings, which is likely to help the price of KZIA stock rise.
KZIA stock was up in pre-market trading but is down 3.8% as of Thursday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
