Kazia Therapeutics stock seeks FDA guidance on paxalisib approval path

Investing.com - Kazia Therapeutics (NASDAQ:KZIA), currently trading at $7.30 and showing significant volatility with a 97% surge over the past six months, has requested a Type C meeting with the FDA to discuss potential regulatory pathways for its lead PI3K inhibitor paxalisib in glioblastoma multiforme (GBM) treatment, the company announced Monday.

The company plans to seek approval based on results from the previously completed Phase 2/3 GBM Agile study under the FDA’s Project Frontrunner initiative, which aims to accelerate oncology drug approvals for earlier-line patients.

A prespecified secondary analysis of the study showed first-line unmethylated GBM patients treated with paxalisib achieved a median overall survival of 15.54 months (n=54) compared to 11.89 months for control patients on standard care (n=46).

If the FDA agrees with Kazia’s proposal, the company plans to initiate a confirmatory Phase 3 study before submitting a New Drug Application (NDA).

H.C. Wainwright reiterated a Buy rating and $13.00 price target on Kazia Therapeutics stock, noting uncertainty remains since the primary endpoint for all patients was not met in the GBM Agile study.

In other recent news, Kazia Therapeutics Limited has announced its intention to seek further feedback from the U.S. Food and Drug Administration (FDA) regarding its brain cancer drug, paxalisib. The company plans to request a follow-up Type C meeting with the FDA to discuss overall survival data related to this treatment. Kazia aims to align its regulatory approach with the FDA’s Project FrontRunner initiative. This initiative encourages the development of cancer treatments for use in earlier clinical settings, rather than solely for patients who have exhausted other options. These developments highlight Kazia’s ongoing efforts to advance paxalisib through the regulatory process. The company is focusing on potentially expanding the drug’s applicability and availability to a broader patient population. This move indicates Kazia’s strategic efforts to seek regulatory approval and potentially enhance the treatment options for glioblastoma.

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