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Regulatory hurdles may lead to delayed approval, impacting KZIA's stock performance, similar to prior FDA interactions delaying other biotech firms.
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KZIA's stock declines 40.3% after regulatory update on paxalisib. FDA suggests overall survival data is not suitable for accelerated approval. Positive secondary endpoint data from GBM-AGILE study supports further testing. Kazia plans pivotal phase 3 study based on FDA discussions. CEO expresses intent to outline a path for shareholder value by January 2025.
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