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Kazia Therapeutics Limited

KZIA
OvervaluedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$8.97
▲ +0.15 · +1.7%

Financials

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52W LOW $4.8652W HIGH $17.40
Volume
35.03 K
Value Traded
3.02 M
Short % Float
7.83%
-3.24%Week
-24.49%1 Month
-33.85%3 Month
+1.7%6 Month
-97.03%5 Year
-99.41%All Time

Cash Data

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  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
115.29 M
EPS (TTM)
-6.82
P/E Ratio
-
Ent. Value
108.60 M
Total Shares
12.97 M
Float Shares
9.83 M
Insiders
14.01%
Institutions
36.49%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Pre-clinical data presentation
paxalisib
HR+/HER2- breast cancer (preclinical benchmarking)
Pre-clinicalSmall MoleculesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

KZIA Catalyst Timeline

Dated clinical, regulatory and corporate events for Kazia Therapeutics Limited

Catalyst Timeline

Dated clinical, regulatory & corporate events for Kazia Therapeutics Limited

484Total events
26Upcoming
111Tier-1 (high impact)
2017 to 2028Coverage

Upcoming catalysts 2

T2Trial Initiation
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Paxalisib
T3Additional Data
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Paxalisib

Event history 50

▲First Patient DosedPaxalisibTrial
Sovargen doses first patient in Phase 1b/2a trial of paxalisib for FCD T2 and TSC
intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC)source ↗
▲Milestone PaymentPaxalisibCorporate
$2 million development milestone payment to Kazia triggered by first patient dosing
intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC)source ↗
▲First Patient DosedPaxalisibTrial
First patient dosed in Arm A of PNOC035 evaluating paxalisib plus gemcitabine in recurrent/progressive AT/RT
recurrent or progressive atypical teratoid/rhabdoid tumor (AT/RT)source ↗
●Quarterly UpdateCorporate
Corporate update conference call
▲Preclinical PoCPaxalisibPreclinical
Adding paxalisib to immunotherapy reduced tumor volume by additional 50% vs immunotherapy alone
MSS/pMMR colorectal cancersource ↗
●Composition Patent FiledPaxalisibIP / Competition
New patent filing covering paxalisib's potential use in colorectal cancer
colorectal cancersource ↗
▲Patent GrantedPaxalisibIP / Competition
Provisional patent application filed
HR+/HER2- breast cancersource ↗
▲Patent GrantedIP / Competition
Provisional patent application filed for HR+ breast cancer findings
HR+/HER2- breast cancersource ↗
●Protocol AmendmentPaxalisibTrial
Protocol amendment to add three-arm expansion to ongoing TNBC trial
HR+/HER2- metastatic breast cancersource ↗
▼Equity OfferingCorporate
Closing of oversubscribed public offering
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How KZIA actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-03-31NDL2 Pre-clinical data readout Pre-clinical
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D36 / 100
Pipeline Score
$41M
Pipeline Value
Overvalued
Valuation Signal
3
Drugs Scored
0.3x
rNPV / MCap
Top 51%
Micro Cap
(rank 336 of 658)
Percentile Rank
Kazia Therapeutics Limited faces pipeline headwinds (36/100), with $572M risk-adjusted pipeline value, led by Paxalisib in CDK Gene Mutation (Phase 2).
Showing 1 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Paxalisib Small moleculeNCT03994796CDK Gene MutationPhase 2 ACTIVE NOT_RECRUITING 50Jun 1, 2028
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Clinical Trial Results

Readouts, endpoints and source filings for every KZIA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
paxalisib
Fast TrackOrphanRare Pediatric
advanced triple-negative breast cancerPhase 1b2026-08-27clinical benefit rate: 100%; objective response rate: 83%; complete response: 1; partial responses: 4; stable disease: 1; median reduction CTC clusters: 83%; median reduction terminally exhausted T cells: 51%Read MoreKazia Therapeutics Reports 100% Clinical Benefit Rate in Initial Six Patients Treated for Advanced Triple-Negative Breast CancerRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Coffey Steven R. S.DirectorGrant/Award 100,000 100,000 held$0.00 01/08/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in KZIA for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

KZIA Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How KZIA ranks across every disease it competes in

Competitive Position is a premium feature
See how KZIA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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KZIA News

KZIA
Sep 22, 2026
KZIAPhases

Kazia Therapeutics Announces Sovargen Co. Doses First Patient in Phase 1b/2a Trial of Paxalisib for Rare Seizure Disorders

Kazia Therapeutics announced that Sovargen Co. has dosed the first patient in a Phase 1b/2a trial of paxalisib for treating intractable epilepsy related to focal cortical dysplasia type 2 and tuberous sclerosis complex. This milestone triggers a $2 million payment to Kazia. The trial aims to explore paxalisib's potential in addressing significant unmet medical needs in these rare disorders.

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KZIA
Sep 9, 2026
KZIAPhases

Kazia Therapeutics Announces First Patient Dosed in PNOC035 Clinical Study Evaluating Paxalisib for Recurrent Pediatric AT/RT Brain Cancer

Kazia Therapeutics has announced the dosing of the first patient in the PNOC035 clinical study, evaluating paxalisib combined with gemcitabine for recurrent pediatric AT/RT. This Phase 2 study aims to provide new treatment options for a cancer with no approved therapies. The combination has shown promising preclinical results, significantly increasing median survival.

Read more →
KZIA
Sep 1, 2026
KZIAPhases
▼ -8.3%on this news

Kazia Therapeutics Reports Preclinical Data Showing Paxalisib Reprograms Immunotherapy-Resistant MSS/pMMR Colorectal Cancer and Enhances Response to Immunotherapy

Kazia Therapeutics reported promising preclinical data for paxalisib, which demonstrated a 52% reduction in tumor burden in MSS/pMMR colorectal cancer models. The addition of pembrolizumab further enhanced tumor reduction by 50%. The company plans to initiate a Phase 2 clinical trial to evaluate paxalisib's efficacy in immunotherapy-resistant colorectal cancer. The treatment was well tolerated, showing no significant toxicity.

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KZIA
Sep 1, 2026
KZIAPhases
▼ -8.3%on this newsshared move

Kazia Therapeutics Expands Paxalisib Clinical Trial into HR+/HER2- Breast Cancer, Supported by Preclinical Data Showing Strong Clinical Activity and Safety in HR+ Breast Cancer

Kazia Therapeutics is expanding its ongoing clinical trial of paxalisib into HR+/HER2- breast cancer, supported by promising preclinical data. The trial will evaluate paxalisib combined with standard therapies and aims to address significant unmet medical needs. The first patient is expected to be enrolled by the end of 2026, with full enrollment anticipated by 2027.

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KZIA
Aug 31, 2026
KZIAGeneral
▼ -8.3%on this newsshared move

Kazia Therapeutics Limited Announces Oversubscribed Closing of Up to $120 Million Public Offering

Kazia Therapeutics Limited has successfully closed an oversubscribed public offering, generating approximately $40 million in upfront gross proceeds, with potential total proceeds of $120 million. The offering includes American Depositary Shares and warrants linked to clinical milestones for breast cancer treatments. Kazia plans to utilize the funds primarily for the clinical development of its lead asset, paxalisib.

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KZIA
Aug 28, 2026
KZIAGeneral
▼ -19.6%on this newsshared move

Kazia Therapeutics Limited Announces Pricing of Up to $120 Million Public Offering

Kazia Therapeutics Limited has announced a public offering priced at $15.50 per American Depositary Share, aiming to raise up to $120 million. The offering includes warrants and is expected to close by August 31, 2026. Proceeds will primarily fund clinical development of paxalisib for various oncology indications. The company has ongoing trials and has received multiple designations from the FDA.

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KZIA
Aug 27, 2026
KZIAGeneral
▼ -19.6%on this newsshared move

Kazia Therapeutics Limited Announces Proposed Public Offering

Kazia Therapeutics Limited has announced a proposed public offering of American Depositary Shares (ADSs) and warrants to fund the clinical development of its lead asset, paxalisib. The offering is intended to support ongoing studies in triple-negative breast cancer and HR+/HER2- breast cancer. The completion of the offering is subject to market conditions, and there are associated risks regarding clinical milestones and regulatory approvals.

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KZIA
Aug 27, 2026
KZIAPhases
▼ -19.6%on this newsshared move

Kazia Therapeutics Reports 100% Clinical Benefit Rate in Initial Six Patients Treated for Advanced Triple-Negative Breast Cancer

Kazia Therapeutics reported a 100% clinical benefit rate in six patients with advanced triple-negative breast cancer treated with paxalisib. Five patients showed significant tumor reductions, including one complete response. The treatment demonstrated a favorable safety profile, with no serious adverse events. The ongoing Phase 1b trial aims to further explore paxalisib's efficacy in combination with other therapies.

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KZIA
Jul 28, 2026
KZIAFDA Updates

Kazia Therapeutics Announces the Filing of Provisional Patent for Novel Strategy, Supported by Preclinical Data, to Prevent Metastatic Recurrence in Triple-Negative Breast Cancer

Kazia Therapeutics has filed a provisional patent for a new therapeutic strategy aimed at preventing metastatic recurrence in high-risk early-stage triple-negative breast cancer (TNBC). Supported by promising preclinical data, the strategy involves the use of paxalisib, which has shown a significant reduction in residual disease and lung metastasis. The company is looking to broaden the clinical development of paxalisib based on these findings.

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KZIA
Jun 2, 2026
KZIAGeneral
▼ -6.1%on this news

Kazia Therapeutics Appoints James Levine as Chief Financial Officer

Kazia Therapeutics has appointed James Levine as Chief Financial Officer, effective June 1, 2026. Levine brings over 20 years of experience in financial leadership within the biotech sector. His role is expected to support Kazia's advancement of its lead asset, paxalisib, and the development of its oncology pipeline. The company is targeting multiple cancer indications with promising clinical trials underway.

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KZIA
May 26, 2026
KZIAPhases
▼ -8.4%on this news

Kazia Therapeutics Expands Ongoing Phase 1b Trial of Paxalisib in Advanced Breast Cancer

Kazia Therapeutics has announced an expansion of its ongoing Phase 1b trial for paxalisib in advanced triple negative breast cancer, increasing patient enrollment from 12 to 36. This decision follows positive safety and tolerability data. The trial aims to assess the efficacy of paxalisib in combination with pembrolizumab and chemotherapy, with updates expected throughout 2026 and 2027.

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KZIA
Apr 27, 2026
KZIAGeneral

NASDAQ: KZIA | X: @KaziaTx Beyond Inhibition. Reprogramming Cancer Control. 2026 Corporate Overview April 2026 This presentation contains forward - looking statements, which can generally be identified as such by the use

Kazia Therapeutics is a clinical-stage oncology company focused on developing next-generation therapies for high-need cancers. The company highlighted its lead asset, paxalisib, a dual PI3K/mTOR inhibitor, and other candidates like NDL2 and EVT801 in its corporate overview. With ongoing trials and approximately $46 million in cash, Kazia is positioned to continue its research and clinical programs into 2029. The company aims to redefine cancer treatment by going beyond conventional methods and targeting fundamental drivers of cancer biology.

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KZIA
Apr 15, 2026
KZIAGeneral
▲ +5.7%on this news

Kazia Therapeutics Strengthens Scientific Leadership with Appointment of Dr. Sudha Rao as Chief Scientific Officer to Lead Next-Generation Oncology Platform

Kazia Therapeutics has appointed Dr. Sudha Rao as Chief Scientific Officer to lead its oncology platform. Dr. Rao, a pioneer in epigenetic therapies, will oversee research and development, focusing on advancing Kazia's pipeline, including paxalisib and novel PD-L1 degradation strategies. Her leadership is expected to strengthen Kazia's integrated oncology strategy.

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KZIA
Apr 14, 2026
KZIAGeneral
▲ +5.2%on this news· ran to +23% by day 3shared move

Kazia Therapeutics Expands Oncology Platform with First-in-Class SETDB1 Inhibitor Drug Development Platform

Kazia Therapeutics has in-licensed a first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer. The lead candidate, MSETC, aims to restore immune signaling in tumors resistant to immunotherapy. This program is part of Kazia's strategy to address cancer treatment resistance through innovative therapies. The SETDB1 program is currently in preclinical development with a clear path toward IND-enabling studies.

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About Kazia Therapeutics Limited

Headquarters140 WICKS RD, NEW SOUTH WALES 2113, C3, 2113
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