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Our client, ASX-listed oncology company Kazia Therapeutics Ltd (ASX: KZA; NASDAQ: KZIA, has had a huge few months, including the achievement of significant milestones for lead drug candidate, paxalisib.
Just last week, the company announced it had raised $16.4m through an institutional entitlement offer, part of a broader institutional and retail offer looking to raise $25m, to help fund its participation in GBM AGILE – a pivotal study being used to seek regulatory approval for paxalisib for the treatment of glioblastoma – the most common and aggressive form of primary brain cancer.
The successful institutional raise capped off a busy period for the company, with Kazia announcing a new collaboration with the Dana-Farber Cancer Institute in the US in September. This will see the Institute initiate a phase II trial of paxalisib in in primary central nervous system lymphoma, a potential new indication for paxalisib and marking the sixth ongoing clinical trial for the drug.
In August, the company received three awards from the US Food and Drug Administration (FDA) which could potentially expedite the development and regulatory approval of paxalisib for the treatment of a range of highly aggressive brain cancers.
Kazia was awarded the following by the FDA for the drug:
- Orphan Drug Designation (ODD) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer. ODD is a special status accorded to drugs which are considered promising potential treatments for rare (‘orphan’) diseases, generally defined as those which affect less than 200,000 cases per annum in the United States. Read the ASX Announcement here.
- Fast Track Designation (FTD) for the treatment of glioblastoma. FTD is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions and gives Kazia substantially increased access to the FDA. Read the ASX Announcement here.
- Rare Pediatric Disease Designation (RPDD) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG). RPDD may now be eligible to receive a ‘rare pediatric disease priority review voucher’ (PRV) if paxalisib is approved for DIPG. A PRV grants the holder an expedited six-month review of a new drug application by FDA. Read the ASX Announcement here.
Following the grant of RPDD, IR Department secured an interview with Kazia collaborator, Dr Matt Dun and Kazia CEO, Dr James Garner on Channel 7’s Sunrise, in which Dr Dun and Dr Garner discuss the role paxalisib may have to play in treating the rare pediatric brain tumour, Diffuse Intrinsic Pontine Glioma (DIPG).
You can watch the video here.
In July, broker Bell Potter also initiated coverage on Kazia with a Speculative Buy rating on the stock. In August, the broker lifted its valuation on Kazia to $1.50, from $1.00.
For more information on Kazia’s capital raising, you can access the most recent investor presentation here.