.Don't recall period of RPDD extension for Paxalisib in DIPG off the top of my head but remember, DIPG is not the only RPDD Kazia has with Paxalisib. Summer/winter, depending on hemisphere, of last year they got that designation in AT/RT. (July 2022)
Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) has been awarded a Rare Paediatric Disease Designation (RPDD) by the US Food and Drug Administration (FDA) for the use of paxalisib in the treatment of atypical rhabdoid/teratoid tumours (AT/RT), a rare and highly aggressive childhood brain cancer.The RPDD is granted to drugs with the potential to treat rare childhood diseases, providing a paediatric priority review voucher (pPRV) if the drug is initially approved for that rare childhood disease.A pPRV allows an expedited six-month review process for a new drug application. As a tradable voucher, a pPRV can command prices of more than A$147 million (US$100 million).Targeting brain cancer indications“This is the second time that paxalisib has been granted RPDD and it demonstrates the importance of childhood brain cancer in the overall paxalisib development program,” Kazia Therapeutics CEO Dr James Garner said.
KZA Price at posting:
18.0¢ Sentiment: Buy Disclosure: Held
