Welcome to our dedicated page for Kazia Therapeutics news (Ticker: KZIA), a resource for investors and traders seeking the latest updates and insights on Kazia Therapeutics stock.
Kazia Therapeutics Limited develops clinical-stage oncology therapies through an Australian foreign-issuer structure whose American depositary shares trade under KZIA. Company news centers on paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor being developed across brain cancer and advanced breast cancer indications, including triple-negative breast cancer studies that report clinical and translational findings.
Recurring updates also cover Kazia's broader oncology platform, including NDL2, a PD-L1 protein degrader platform, and MSETC, a SETDB1-targeted epigenetic program. Additional company developments include research leadership, licensing activity, financing and capital-structure actions, Nasdaq listing compliance, annual meeting matters, governance changes, and operating or financial results.
Kazia Therapeutics (Nasdaq: KZIA) has in-licensed a first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer, including the lead candidate MSETC and an AI-integrated discovery engine. The program is in preclinical development with a planned IND-enabling path.
Management expects to advance the SETDB1 and PD-L1 degrader programs to IND readiness for approximately $6 million over 18 months, with an upfront payment of $1.39 million and a tiered revenue-sharing structure.
Kazia Therapeutics (NASDAQ: KZIA) reported preclinical and translational data for NDL2, a bicyclic peptide degrader designed to selectively remove nuclear PD-L1, an intracellular driver of immunotherapy resistance and metastasis. In murine TNBC models NDL2 reduced tumor volume by 49% as monotherapy and 73% with anti-PD-1, plus a 50% reduction in lung metastases in combination. Data show immune reprogramming, favorable preclinical safety/PK, and liquid biopsy biomarker evidence. IND-enabling studies are underway with first-in-human trials targeted for 2027 and a planned dataset presentation in Q2 2026.
Kazia Therapeutics (NASDAQ: KZIA) reported preliminary clinical responses from its ongoing Phase 1b study of paxalisib combined with pembrolizumab and chemotherapy in late-stage metastatic triple-negative breast cancer (TNBC). To date, three patients treated with paxalisib-based regimens showed meaningful responses: two partial responses in trial participants and one confirmed complete metabolic response under expanded access. Median time on treatment is ~6.1 months, all patients remain on therapy, and paxalisib at 30 mg daily showed generally favorable tolerability. The company plans additional site activations and targets 12 TNBC patients by end-2026 with topline data in early 2027.
Kazia Therapeutics (NASDAQ: KZIA) said CEO John Friend will attend J.P. Morgan Healthcare Conference week and meet investors and partners.
The company highlighted it is well capitalized after a recent financing and expects a clinical and translational update before month-end from its Phase 1b paxalisib trial in advanced triple-negative breast cancer (TNBC), including additional clinical responses and expanded circulating tumor cell (CTC) and CTC cluster biomarker analyses. Kazia also plans the first update on its PD-L1 protein degrader program.
Kazia Therapeutics (NASDAQ: KZIA) regained full compliance with all Nasdaq listing standards on Dec 18, 2025 after Nasdaq confirmed the company meets Listing Rule 5550(b)(1) (the $2.5 million minimum stockholders' equity alternative to MVLS).
The restoration follows a $50 million private placement led by healthcare institutional investors that the company says materially strengthened its balance sheet; the previously scheduled Nasdaq hearing was cancelled as moot and Kazia's ADS will continue trading on The Nasdaq Capital Market.
Kazia Therapeutics (NASDAQ: KZIA) reported translational and early clinical data (Dec 10, 2025) showing paxalisib activity across HER2+ and triple‑negative breast cancer.
Key findings: an early TNBC patient showed ~76% primary tumor volume shrinkage and reversal of CD8 T‑cell exhaustion; ex vivo HER2+ samples showed paxalisib reduced single circulating tumor cells (CTCs) by 42% and CTC clusters by 78%; resumption after a 3‑week pause re‑suppressed CTC clusters, indicating a direct pharmacodynamic effect. Data support paxalisib's potential to disrupt mesenchymal, metastatic CTC clusters and to reinvigorate anti‑tumor immunity, informing combination strategies with pembrolizumab, PARP inhibitors, and chemotherapy.
Kazia Therapeutics (NASDAQ: KZIA) announced a private placement (PIPE) offering of approximately $50.0 million of ordinary shares and pre-funded warrants at an ADS-equivalent price of $5.00 per ADS (one ADS = 500 ordinary shares). The financing is led by healthcare-dedicated investors and expected to close on December 3, 2025, subject to customary conditions.
Net proceeds are expected to be about $46.5 million after fees and expenses, intended to fund continued clinical development of paxalisib, advance the PD-L1 degrader program, and for general corporate purposes; cash runway is expected into the second half of 2028.
Kazia Therapeutics (Nasdaq: KZIA) reported an initial immune-complete response (iCR) in a single stage IV triple-negative breast cancer (TNBC) patient treated under an FDA-authorized expanded access protocol combining paxalisib with pembrolizumab and chemotherapy.
The company previously reported an 86% tumor burden reduction after three weeks in the same patient and now cites a PET/CT after ~three months showing complete metabolic resolution of lesions consistent with an initial iCR; confirmatory imaging is planned per iRECIST.
Kazia also announced upcoming scientific presentations, an NDL2 PD-L1 degrader program moving toward IND-enabling studies in early 2026, plans to request a FDA Type C meeting on paxalisib GBM overall survival data, and a Nasdaq MVLS noncompliance determination with an intended request for a hearing to stay suspension/delisting.
Kazia Therapeutics (NASDAQ: KZIA) intends to request a Type C meeting with the U.S. FDA to discuss overall survival (OS) data for paxalisib in newly diagnosed glioblastoma (GBM) and to seek feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner.
Key disclosed data: in a prespecified secondary analysis of up-front unmethylated GBM, median OS was 15.54 months for paxalisib (n=54) vs 11.89 months for concurrent standard of care (n=46). Kazia plans to propose initiating a post-approval randomized Phase 3 confirmatory study prior to NDA submission and to present survival analyses, safety data, and trial design to the FDA.
Kazia Therapeutics (NASDAQ: KZIA) on October 7, 2025 announced an exclusive collaboration and in-licensing agreement with QIMR Berghofer for a first-in-class PD-L1 protein degrader program.
The lead optimized compound, NDL2, is described as an advanced PD-L1 protein degrader currently in development and positioned as a novel approach in cancer immunotherapy.