Kazia Therapeuti Stock Price, News & Analysis

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.

Kazia Therapeutics (NASDAQ: KZIA) reported remarkable results from a single-patient expanded access case using their investigational drug paxalisib. The patient, diagnosed with triple-negative breast cancer (TNBC), showed an 86% reduction in overall tumor burden after just three weeks of combination therapy including paxalisib, immunotherapy, and chemotherapy.

The patient, a 40+ year old female initially diagnosed in April 2023, had previously undergone neoadjuvant therapy and surgery before developing metastatic disease in the bones and lungs. The treatment approach mirrors Kazia's ongoing Phase 1b TNBC study, which evaluates paxalisib in combination with Keytruda® and chemotherapy.

Kazia Therapeutics (NASDAQ: KZIA) announced its participation in an Australian Medical Research Future Fund (MRFF) project focused on developing an AI-driven platform for treating diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG). The three-year initiative will establish DMG-ADAPTS, an AI-enabled clinical decision-making platform to optimize therapy sequencing for these aggressive pediatric brain cancers.

The project aims to integrate multiomics profiling with a therapeutic toolkit of twelve brain-penetrant molecules, including Kazia's investigational drug paxalisib, a dual PI3K/mTOR inhibitor. The initiative addresses DMG/DIPG, which accounts for up to 25% of childhood brain cancer deaths with median survival of less than one year. Kazia will provide paxalisib, which has shown encouraging activity in the PNOC 022 pediatric brain cancer trial.

Kazia Therapeutics (NASDAQ: KZIA) has reported breakthrough results from an ex vivo study of paxalisib, their investigational PI3K-mTOR inhibitor, in Stage IV HER2-positive metastatic breast cancer. The study demonstrated that paxalisib monotherapy achieved 100% disruption of circulating tumor cell (CTC) clusters containing three or more cells.

The research, led by Professor Sudha Rao at QIMR Berghofer, revealed significant potential for paxalisib in treating HER2-positive breast cancer, which represents 15-20% of cases. These findings complement Kazia's ongoing Phase 1b trial in triple-negative breast cancer, where initial data from July 2025 showed promising results in reducing CTCs.