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 company announced that it has received Fast Track Designation from the FDA. Here’s what’s going on:

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KZIA Stock Climbs On Fast Track Designation

In the press release, Kazia Therapeutics said that the United States Food and Drug Administration has granted Fast Track Designation to paxalisib. The treatment is designed as a potential option for glioblastoma, the most common and most aggressive form of brain cancer.

As a result of the Fast Track Designation, the KZIA will be able to move forward with the expedited development of the treatment, benefiting from increased communication with the FDA and reduced review periods.

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

In awarding Fast Track Designation to paxalisib, FDA has recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement. 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. In particular, the ‘rolling review’ process enables Kazia to complete and submit substantial sections of our NDA filing in advance, saving time and reducing risk for the product. We look forward to working closely with FDA as we move into the final stage of development for paxalisib.

This News Is Huge

The news released by Kazia Therapeutics this morning proved to be overwhelmingly positive. After all, Fast Track Designation comes with quite a few perks. Not only will the company have increased access to the FDA, it will be able to submit data for its NDA on a rolling basis, rather than waiting for all data to be available and compiled together.

This means that if the treatment is going to be approved in the United States, it’s going to happen faster now. Moreover, if this treatment is approved, it could be a huge winner for KZIA. The Glioblastoma treatment market is expected to climb to be worth more than $3 billion annually in coming years. With few options, if this treatment proves to be effective, it has the potential to take a lion’s share of that market. With the recent positive news from KZIA and the market potential here, the stock is one to watch closely.

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