Kazia Therapeutics Ltd (ASX: KZA) share price has skyrocketed 34% today after announcing the US Food and Drug Administration (FDA) had granted fast track designation (FTD) for Kazia’s drug, paxalisib.
Paxalisib is used for the treatment of glioblastoma, which is the most common and aggressive form of primary brain cancer.
Fast track designation is a significant opportunity for Kazia Therapeutics because it speeds up the development of pharmaceutical products that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
Additionally, it provides Kazia with better access to the FDA, including opportunities for face-to-face meetings and written consultation throughout paxalisib’s development.
Companies with drugs given FTD designation are eligible to apply for accelerated approval and priority review. It could lead to faster product approval.
Kazia Therapeutics CEO Dr James Garner said by awarding FTD to paxalisib, the FDA had recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma.
“This is a very powerful acknowledgement,” Dr Garner said. “The opportunities that fast track designation creates, as we move towards an NDA filing, are of great value and have the potential to substantially accelerate the commercialisation of paxalisib…
“Additionally, the company is looking forward to working closely with the FDA as it moves into the final stage of development of the drug.”
Where to next?
Kazia Therapeutics completed recruitment to its phase II clinical trial of paxalisib in newly diagnosed glioblastoma in February this year. It presented its interim clinical data at the American Association of Cancer Research (ACCR) virtual annual meeting II in June 2020.
Pleasingly, the survival rate of Kazia’s drug, paxalisib was calculated at 17.7 months which compares favourably to the existing FDA-approved standard of care drug, temozolomide, which is 12.7 months.
The company expects to present further data from its study in the second half of this year and to finish the study early next year.
Additionally, paxalisib has been selected to join the international GMB AGILE pivotal study in glioblastoma. Recruitment is expected to begin in the second half of this year.
About Kazia Therapeutics share price
Kazia Therapeutics is an oncolgy-focused biotechnology company based in Sydney, Australia. Its pipeline includes two clinical-stage drug development candidates, and it’s looking to develop therapies across a range of oncology indications.
The market has responded positively to today’s news sending the share price up 33.94% at time of writing to be trading at $1.10. It has a market capitalisation of $104.5 million.