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What Sparked Kazia Therapeutics' Over 51% After-Hours Surge? - Kazia Therapeutics (NASDAQ:KZIA)

Kazia's patient with metastatic triple-negative breast cancer showed an initial immune-complete response, surpassing typical 0.6-4% complete response rates for pembrolizumab monotherapy.

  • Kazia Therapeutics Limited announced a patient with stage IV triple‑negative breast cancer treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab and chemotherapy achieved an initial immune-complete response per iRECIST criteria.
  • Kazia and investigators hypothesize the paxalisib plus pembrolizumab and chemotherapy strategy addresses checkpoint inhibitor resistance, noting `Although this is a single expanded-access case and requires confirmatory imaging, the depth of response aligns closely with our mechanistic hypothesis.`
  • Imaging showed the patient had an 86% reduction in tumor burden after three weeks, with a PET/CT scan after three months confirming complete metabolic resolution consistent with an initial iCR.
  • Unless Kazia timely requests a hearing, Nasdaq staff indicated on Tuesday that its ADSs could be suspended or delisted, and the company plans to request a hearing to stay any action.
  • Kazia intends to request a follow-up FDA Type C meeting to discuss paxalisib survival data and will present at the Brisbane Cancer Conference and SABCS from December 10-14, 2025.
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Kazia Therapeutics Achieves Initial iCR (Immune-Complete Response) in Metastatic TNBC and Delivers Q4 Business Update with Breakthroughs Across Breast Cancer, Immuno-Oncology, and GBM Regulatory Strategy

SYDNEY, Nov. 18, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, today announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab…

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Charleston Gazette-Mail broke the news in Charleston, United States on Tuesday, November 18, 2025.
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