Oncology company Kazia Therapeutics (NASDAQ:KZIA) stock price has surged to its highest level this year after news that the company has been awarded a grant by the United States Food and Drug Administration (FDA) for its lead drug.
So far its shares are up over 100% premarket at $8.60 per share, a level not seen since November 2019.
The new grant has been awarded Rare Pediatric Disease Designation for paxalisib by the FDA, which is used for the treatment of a highly aggressive childhood brain cancer.
The company said that it may now be eligible to receive a ‘rare pediatric disease priority review voucher’ (PRV) if paxalisib is approved as a treatment.
Kazia CEO, Dr James Garner, commented, “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.