Kazia Therapeutics (KZIA) Stock Rockets On FDA News

Kazia Therapeutics KZIA Stock News

Kazia Therapeutics Ltd (NASDAQ: KZIA) is running for the top in the market this morning, and for good reason. The comapny announced that the FDA has granted it Rare Pediatric Disease Designation. Here’s what’s going on:

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KZIA Stock Rockets On Rare Pediatric Disease Designation

In the release, Kazia Therapeutics said that the US FDA has awarded Rare Pediatric Disease Designation for its paxalisib treatment candidate. The treatment is being developed as a potential option for Diffuse Intrinsic Pontine Glioma, a rare, yet highly-aggressive childhood brain cancer. 

As a result of the designation, KZIA may now be eligible for a priority review, reducing the time to market. This potential priority review voucher will provide an expedited, 6-month review of the drug by the FDA. 

The priority review vouchers associated with these designations have massive value. In fact, historically, these vouchers have commanded prices of between $68 million and $350 million if sold to other companies. 

The designation was awarded to KZIA as a result of positive preclinical data. It is expected that the company will release initial clinical efficacy data in the second half of this hyear. Of course, if the data released later this year is positive, it can substantially enhance the likelihood of a future priority review voucher. 

In a statement, Dr. James Garner, CEO at KZIA, had the following to offer:

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. We continue to be inspired by the dedication of our collaborators in this field and are committed to understanding whether paxalisib may be able to help in this enormously challenging paediatric disease.

Final Thoughts

The news announced by Kazia Therapeutics today proved to be overwhelmingly positive. Rare Pediatric Disease Designation is only provided to companies that are showing promise in a rare pediatric disease indication with little-to-no currently approved options. 

That’s exactly the case here. 

This Rare Pediatric Disease Designation will make the FDA more accessible to KZIA. At the same time, the Designation opens doors for a shortened review period and further validates the prospect of the company’s treatment candidate. 

As such, KZIA stock is one to watch closely. 

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