Kazia Therapeutics (NASDAQ:KZIA) news for Friday includes a designation from the U.S. Food and Drug Administration (FDA) sending KZIA stock flying high.
According to a Kazia Therapeutics news release, the company has received a Rare Pediatric Disease Designation for its paxalisib drug from the FDA. This treatment is for Diffuse Intrinsic Pontine Glioma (DIPG), which is a rare form of childhood brain cancer.
What this means for Kazia Therapeutics is that it can now seek a rare pediatric disease priority review voucher (PRV) if the FDA approves paxalisib for treating DIPG. That would grant it an “expedited six-month review” of the drug.
It’s worth pointing out that a PRV can also be sold to other companies. That means that Kazia Therapeutics can sell the voucher to another company that seeks to bring paxalisib to market for treating DIPG.
Here’s what Dr James Garner, CEO of Kazia Therapeutics, said about the news.
“Although glioblastoma remains our primary focus for paxalisib, we have been devoting increasing energy to developing the drug in childhood brain cancer as well. For patients diagnosed with DIPG, there are currently no FDA-approved drug treatments, and the average survival from diagnosis is around 9.5 months. The granting of RPDD by the FDA recognises our efforts and achievements so far and leaves us well placed to move paxalisib forward as a potential therapy for DIPG.”
KZIA stock was up 43.3% as of Friday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.