Research analysts covering KAZIA THERAPEUTICS.
Recent press releases and 8-K filings for KZIA.
Kazia Therapeutics Reports Encouraging Preliminary Clinical Responses for Paxalisib in TNBC Study
KZIA
New Projects/Investments
Guidance Update
- Kazia Therapeutics reported encouraging preliminary clinical responses from its ongoing Phase 1b study evaluating paxalisib in late-stage metastatic triple-negative breast cancer (TNBC) as of January 27, 2026.
- The study observed two partial responses in evaluable patients and one confirmed complete metabolic response in a patient treated under an expanded access program. Paxalisib demonstrated a generally favorable safety and tolerability profile at the 30 mg daily dose.
- Kazia expects to activate two additional clinical sites by April 2026, targets enrollment of twelve TNBC patients by the end of 2026, and anticipates topline data readout in early 2027.
Jan 27, 2026, 1:00 PM
Kazia Therapeutics Announces J.P. Morgan Healthcare Conference Participation and Upcoming Clinical Updates
KZIA
New Projects/Investments
Guidance Update
- Kazia Therapeutics' CEO, John Friend, MD, will participate in the J.P. Morgan Healthcare Conference week in San Francisco next week to engage with investors, analysts, and strategic collaborators.
- The company is well capitalized following a recent financing.
- Kazia anticipates providing a clinical and biomarker update from its Phase 1b trial evaluating paxalisib in advanced triple-negative breast cancer before the end of January.
- Additionally, Kazia plans to release the first update on its PD-L1 protein degrader program.
Jan 8, 2026, 2:00 PM
Kazia Therapeutics Regains Full Nasdaq Listing Compliance
KZIA
Delisting/Listing Issues
- Kazia Therapeutics regained full compliance with all applicable Nasdaq listing standards on December 18, 2025.
- The company received written notification from Nasdaq confirming compliance with Nasdaq Listing Rule 5550(b)(1), the $2.5 million minimum stockholders' equity requirement.
- This restoration of compliance followed a recently announced $50 million private placement of equity securities, which significantly strengthened Kazia's balance sheet and stockholders' equity position.
- As a result, the previously scheduled hearing before the Nasdaq Hearings Panel has been cancelled as moot, and Kazia's American Depositary Shares will continue to trade on The Nasdaq Capital Market.
Dec 22, 2025, 1:00 PM
Kazia Therapeutics Highlights New Clinical Findings for Paxalisib in Breast Cancer
KZIA
New Projects/Investments
- Kazia Therapeutics Limited announced new clinical and translational findings for paxalisib, its brain-penetrant dual PI3K/mTOR inhibitor, demonstrating its ability to reinvigorate anti-tumor immunity across multiple advanced breast cancer populations, including TNBC and HER2+, as of December 10, 2025.
- In HER2-positive metastatic breast cancer, paxalisib reduced single circulating tumor cells (CTCs) by 42% and CTC clusters by 78% ex vivo, while also activating cytotoxic, interferon, chemokine, and inflammatory pathways in patient samples.
- Early clinical data from the first patient in the TNBC Phase 1b study showed 76% primary tumor volume shrinkage and a marked reduction in CTC clusters after a single cycle of paxalisib.
- The company believes these discoveries meaningfully expand the potential utility of paxalisib beyond current development programs, positioning it as a potentially transformative immunotherapy-enhancing agent.
Dec 10, 2025, 9:11 PM
Kazia Therapeutics Presents Positive Paxalisib Clinical and Translational Data
KZIA
New Projects/Investments
- Kazia Therapeutics announced new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) on December 10, 2025, supporting the activity of its drug, paxalisib, in HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC).
- In HER2-positive metastatic breast cancer, paxalisib reduced single circulating tumor cells (CTCs) by 42% and CTC clusters by 78% ex vivo.
- Early clinical data from the first patient in a Phase 1b study for TNBC demonstrated robust suppression of CTC clusters and reversal of T-cell exhaustion after a single cycle of paxalisib.
- The findings suggest paxalisib has the potential to disrupt aggressive CTC clusters, reverse resistance pathways, and reinvigorate immune cells, thereby enhancing responsiveness to immunotherapy across various breast cancer subtypes.
Dec 10, 2025, 1:00 PM
Kazia Therapeutics Completes Private Placement, Addresses Nasdaq Listing Concerns
KZIA
Delisting/Listing Issues
New Projects/Investments
- On December 2, 2025, Kazia Therapeutics Limited entered into Securities Purchase Agreements for a private placement of equity securities, which closed on December 3, 2025.
- The company received net proceeds of approximately $46.5 million from the private placement.
- These proceeds are anticipated to extend the company's cash runway into the second half of 2028.
- The private placement is expected to help the company regain compliance with Nasdaq's continued listing requirements, specifically by achieving stockholders' equity in excess of the $2.5 million requirement. The company had previously received a staff determination letter on November 12, 2025, due to its Market Value of Listed Securities being below the $35 million minimum.
Dec 5, 2025, 9:05 PM
Kazia Therapeutics Announces Pricing of $50.0 Million Private Placement
KZIA
New Projects/Investments
- Kazia Therapeutics Limited announced a private placement of equity securities totaling approximately $50.0 million.
- The offering includes ordinary shares and prefunded warrants, with a purchase price equivalent to $5.00 per ADS.
- The net proceeds, estimated at approximately $46.5 million, are intended to support the continued clinical development of its lead program paxalisib and the PD-L1 degrader program.
- This financing is expected to extend the company's cash runway into the second half of 2028 when combined with existing cash and cash equivalents.
- The transaction is expected to close on December 3, 2025.
Dec 2, 2025, 9:05 PM
Kazia Therapeutics Announces $50.0 Million Private Placement
KZIA
New Projects/Investments
- Kazia Therapeutics has entered into a securities purchase agreement for a private placement (PIPE) of equity securities, raising approximately $50.0 million.
- The PIPE is structured as a straightforward equity investment with a purchase price equivalent to $5.00 per ADS.
- The net proceeds of approximately $46.5 million will be used to support the continued clinical development of its lead program paxalisib, advance the PD-L1 degrader program, and for general corporate purposes.
- This financing is expected to extend the company's cash runway into the second half of 2028.
Dec 2, 2025, 2:00 PM
Kazia Therapeutics Announces Initial Immune-Complete Response in TNBC Patient and Provides Q4 Business Update
KZIA
Delisting/Listing Issues
New Projects/Investments
- Kazia Therapeutics reported an initial immune-complete response (iCR) in a patient with stage IV triple-negative breast cancer (TNBC) treated with a combination of paxalisib, pembrolizumab, and standard chemotherapy.
- The company is advancing its NDL2 PD-L1 degrader program towards IND-enabling studies, which are anticipated to begin in early 2026.
- Kazia plans to request a Type C meeting with the FDA to discuss overall survival data for paxalisib in glioblastoma (GBM) and explore a potential NDA submission pathway under the Project FrontRunner framework.
- Kazia received a Nasdaq staff determination letter on November 12, 2025, for not regaining compliance with the Market Value of Listed Securities (MVLS) Requirement by November 10, 2025, and intends to request a hearing to stay any suspension or delisting action.
Nov 18, 2025, 9:15 PM
Kazia Therapeutics to Request FDA Type C Meeting for Paxalisib in Glioblastoma
KZIA
New Projects/Investments
Product Launch
- Kazia Therapeutics plans to request a Type C meeting with the FDA to discuss overall survival (OS) findings for its drug paxalisib in newly diagnosed glioblastoma (GBM) patients.
- The company aims to seek feedback on a potential conditional approval pathway for paxalisib, aligning with the FDA Oncology Center of Excellence's Project FrontRunner initiative.
- Kazia intends to propose initiating a post-approval, randomized Phase 3 confirmatory study prior to submitting the New Drug Application (NDA).
- In a prespecified secondary analysis, paxalisib demonstrated a median OS of 15.54 months in newly diagnosed unmethylated GBM patients, compared to 11.89 months for concurrent standard of care.
Oct 27, 2025, 11:15 AM
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