Kazia Therapeutics has been awarded 'Drug Discovery Company of the Year' in the 2026 BioTech Breakthrough Awards for its innovative cancer therapies.

Kazia Therapeutics has announced the acceptance of two abstracts focusing on paxalisib's unique tumor reprogramming mechanisms for presentation at the 2026 SABCS.

Read the full paper: Paxalisib with Trastuzumab for HER2-Positive Metastatic Breast Cancer with Active Brain Metastases: A Phase II Trial with Integrated Plasma and CSF ctDNA Analyses

Kazia Therapeutics has advanced the development of Paxalisib, initiating its first patient trial for rare epilepsy disorders, marking a significant clinical milestone.

Reported Tuesday, Sep 22 - 7:37am EDT (TheFly subscription required to read more.)

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Clinical Milestone Expands Development of Paxalisib Beyond Oncology and Triggers $2 Million Payment to Kazia SYDNEY, Sept. 22, 2026 /PRNewswire/ — Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced that Sovargen Co., Ltd., a biotechnology company specializing in central […]

Key Points Kazia Therapeutics dosed the first patient in PNOC035, a Phase 2 study of paxalisib plus gemcitabine for recurrent or progressive AT/RT. The

Multicenter study to evaluate paxalisib plus gemcitabine for children and young adults with recurrent or progressive AT/RT, where no approved therapies currently exist SYDNEY, Sept. 9, 2026 /PRNewswire/ — Kazia Therapeutics Limited (NASDAQ: KZIA) (“Kazia” or the “Company”), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, […]

Kazia Therapeutics has made a groundbreaking advancement in the treatment of pediatric brain cancer with the dosing of its first patient in a clinical study evaluating paxalisib.

Kazia Therapeutics has reported promising preclinical results for its drug Paxalisib, indicating its potential to treat immunotherapy-resistant colorectal cancer effectively.

Paxalisib Monotherapy Significantly Reduced Tumor Burden in Pre-Clinical Model of MSS/pMMR Colorectal Cancer, With the Addition of Pembrolizumab Driving a Further Reduction Paxalisib Was Well Tolerated as Monotherapy and in Combination with Checkpoint Inhibition Kazia is Preparing to Advance Paxalisib Into a Phase 2 Clinical Study to Evaluate Paxalisib in Immunotherapy-Resistant MSS/pMMR Colorectal Cancer SYDNEY, […]

Paxalisib Monotherapy Significantly Reduced Tumor Burden in Pre-Clinical Model of MSS/pMMR Colorectal Cancer, With the Addition of Pembrolizumab Driving a Further Reduction Paxalisib Was Well Tolerated as Monotherapy and in Combination with Checkpoint Inhibition Kazia is Preparing to...

Preclinical Data Show Paxalisib Combined With Standard-of-Care Therapy Is Well Tolerated and Produces Statistically Significant Antitumor Activity Three-Arm Expansion of the Ongoing TNBC Trial Will Evaluate Paxalisib Plus Fulvestrant, With Palbociclib, Versus Standard-of-Care First...

Kazia Therapeutics (NASDAQ: KZIA) reported new preclinical and translational data showing its PI3K/mTOR inhibitor paxalisib reduced tumor burden by 52% (p=0.035) in a microsatellite stable / proficient mismatch repair (MSS/pMMR) colorectal cancer model. In a separate study, adding paxalisib to an existing checkpoint inhibitor immunotherapy cut tumor volume by an additional 50% versus immunotherapy alone (p=0.022). Across both models, treatment was well tolerated with no treatment-related toxicity observed.Kazia is also running a next-generation biomarker program to define molecular, immune and epigenetic signatures linked to paxalisib response, and has filed a new patent related to colorectal cancer use. The company plans a five-arm Phase 2 trial in pre-treated MSS/pMMR metastatic colorectal cancer, testing paxalisib monotherapy and combinations with pembrolizumab versus standard of care. The primary endpoint will be safety and tolerability, with key efficacy endpoints as secondary measures. Enrollment is expected to start in Q1 2027, with full enrollment of all five arms targeted by year-end 2027.

Kazia Therapeutics is set to expand its clinical trial for HR+/HER2- breast cancer after revealing preclinical data that shows promising efficacy and safety for paxalisib.

Reported Tuesday, Sep 1 - 7:35am EDT (TheFly subscription required to read more.)

Preclinical Data Show Paxalisib Combined With Standard-of-Care Therapy Is Well Tolerated and Produces Statistically Significant Antitumor Activity Three-Arm Expansion of the Ongoing TNBC Trial Will Evaluate Paxalisib Plus Fulvestrant, With Palbociclib, Versus Standard-of-Care First Patient Expected By Year-End 2026 and Full Enrollment by End of 2027 SYDNEY, Sept. 1, 2026 /PRNewswire/ — Kazia Therapeutics Limited (NASDAQ: […]

Reported Tuesday, Sep 1 - 7:21am EDT (TheFly subscription required to read more.)

Kazia Therapeutics Limited announces the successful closing of an oversubscribed public offering, raising $40 million initially, with potential total proceeds reaching $120 million.

Kazia Therapeutics reports groundbreaking results from a study of paxalisib, showing 100% clinical benefit in six patients with advanced TNBC.

Kazia Therapeutics Limited announces its new registered public offering designed to support the development of its innovative oncology therapies.

Kazia Therapeutics (NASDAQ: KZIA) reported initial data from six evaluable Stage IV triple-negative breast cancer (TNBC) patients treated with its lead asset, paxalisib, in an ongoing Phase 1b trial combining paxalisib with pembrolizumab and chemotherapy. All six patients achieved clinical benefit, yielding a 100% clinical benefit rate. Five patients achieved an objective response (one complete, four partial), for an 83% objective response rate, and one patient had stable disease. A 44-year-old woman achieved a complete metabolic response with no evidence of disease since November 2025. No paxalisib-related serious adverse events were reported, and no grade 3 or higher hyperglycemia, stomatitis or mucositis were observed.Translational analyses showed median reductions of 83% in circulating tumor cell clusters within six to seven weeks and 51% in terminally exhausted CD8+ T cells within about three weeks, with preserved total CD8+ T cell counts and blood-based evidence of improved immune function. Enrollment in the Phase 1b study is expected to complete by July 2027, with interim updates anticipated throughout 2026 and 2027.

An Australian #Biotech company is already turning heads so far on Wednesday after it was announced results from its GBM-AGILE, which is a hase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with…