Kazia Therapeutics Ltd (KZIA) Quote

Big Upward Move Coming. FDA Approval Probably

$1 break is close.

Buying is picking up

.70 close is a good possibility.

Grabbed a few more.

More charts... se replied to for long term chart.

Heading back below $0.50 the sellers of the $0.50 puts morons served on a half shell

credentials still work hadnt been here in a few years

interesting volume 3rd leg next week hmmmm

After Hours trading looking Good...

Should open above 1.50 at 9:30am...

Bought the Dip at 1.00 average...

GhosT

Is it too high to buy....Volume was good...Has seemed to Wane a bit...

Good Call Ghost...This thing ran from 20 to 160 in a couple days...wow...I remember seeing it at 30...

Closed my Position at 1.45 average...

On watch for now...

GhosT

TOP IN AGAIN

Thank you Tommyboy🥰

$KZIA
$KZIA Highlighted the break over the 200 day MA yesterday during trading..pointed out how much room it had to run..just over $1 now Premarket..In pure beast mode now.. let’s see if it can get through the residence between $1-$1.15.. pic.twitter.com/YHRJarumZR— Chris from Massachusetts AKA TommyboyTrader (@autumnsdad1) July 11, 2024

If you can stomach the volatility then you will be just fine!

Yes indeed ! Have they applied for FDA

I feel you have to go with Xena's chart in the long term. The News yesterday was huge and moving forward if this passes phase 3 FDA approval a major pharmaceutical Company will buy it out!

Hi all. im new here. The explosion yesterday brought me to this stock. Am I late or has this got the potential to break over a dollar. thanks

Intriguing long term chart...



another chart:

algo trap

$KZIA +248% #DDAmanda Video Analysis - #1 Stock Scanner/Screener



Z

KZIA: My BAD!!! ("Finviz", below, says YOU are correct!!)
https://finviz.com/quote.ashx?t=KZIA&p=d
Google, below, mislead me:
https://www.google.com/search?q=kzia+stock+float&sca_esv=54722a0b5ffac30e&sca_upv=1&source=lnms&sa=X&ved=2ahUKEwjyta_75Z2HAxWIBe8CHd5GABEQ0pQJegQIBRAC&biw=1366&bih=657&dpr=1

The outstanding shares are only about 23,000,000:
https://www.otcmarkets.com/stock/KZIA/security

Nice strong A.H. close at .95 :)

After Hours trading looking good...

Should open above 1.00 at 9:30am...

Bought the Dip 0.58 average...

GhosT

KZIA: 243-million Float, & yet soared like that??? (O.K., so there goes the old "Small-Float" theory.)

KZIA........................................https://stockcharts.com/h-sc/ui?s=KZIA&p=W&b=5&g=0&id=p86431144783

yeah, mine wasn't top of cloud but .40 to .82 not bad i guess

One of the drugs with the Standard of care for glioblastoma is Temodar.

Temodar had sales of $800 million in 2022.

Hmmm .... makes this stock with a market cap of less than $30 million look interesting?

We shall see, but it looks good....

NO...TOP OF CLOUD EXIT

you still holding?

WOW YOU ARE GOOD...CALLING HALTS DOES NOT MAKE $$$

About to halt

KZIA...DOLLA BREAK

KZIA...TOP WEEKLY CLOUD TEST COMING UP

HERE WE GO TO A DOLLA

Why don’t I ever get lucky like this? Smh

Let's get back over $1.00 and b become compliant again :)

Crazy

KZIA...78C HALT....LETS SEE A DOLLAR

KZIA...HERE WE GO TO 77C

KZIA...77C MAGNET UP AHEAD

KZIA HERE WE GO ...NEW HIGH BREAK

KZIA...HERE WE GO

KZIA HERE WE GO

KZIA...ON THE MOVE PHASE 3 RESULTS

Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma
GBM AGILE trial data shows clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma

SYDNEY, July 10, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics.


GBM AGILE STUDY
GBM AGILE is an adaptive phase II/III global trial sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world's foremost clinical, translational, and basic science researchers, from institutions such as Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute. The trial is designed to efficiently screen for and characterize the response of glioblastoma (GBM) patients to novel investigative agents. Utilizing a complex innovative design, Bayesian principles are applied to the primary endpoint (Overall Survival) comparison of the investigational agents to patients receiving Standard of Care (SOC) enrolled from the study start (also referred to as cumulative control population). In general, secondary analyses and endpoints are assessed based on established statistical models in comparison to the control patients enrolled at the same time as the investigational agent (concurrent control population).

Paxalisib is the third drug candidate to complete its evaluation in the study and was evaluated in newly diagnosed glioblastoma patients with unmethylated MGMT promoter status as well as in patients with recurrent disease.

GBM AGILE Paxalisib Results

Kazia CEO, Dr John Friend stated, "We are excited to have shown a 3.8 month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard of care arm. Having comparable Overall Survival data across two independent studies is a compelling outcome in this difficult to treat glioblastoma population. We look forward to discussing possible approaches for an accelerated approval pathway for paxalisib with the FDA."

A total of 313 newly diagnosed unmethylated (NDU) patients and recurrent patients being treated at top US cancer hospitals were randomized in Stage 1 to either a paxalisib treatment arm (60 mg/day) or the SOC concurrent control arm from January 2021 to May 2022. The cumulative control arm was enrolled from July 2019 (GBM Agile study start date) to May 2022.

For the primary analysis the median Overall Survival (OS) was 14.77 months for paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75).

For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the paxalisib arm (n=54) versus 11.89 months for concurrent SOC (n=46). In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months).

The secondary analysis results are consistent with the previously reported Company-sponsored phase II study, where median OS was 15.7 months (n=27) for paxalisib treated NDU patients compared to 12.7 months historically reported with temozolomide in this patient group (Wen 2022).

Paxalisib was well tolerated in GBM-AGILE, and no new safety signals were identified in this patient population.

An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for paxalisib (n=100). Similar results in this population have been reported in the other two drug candidates that have completed the GBM AGILE trial. Kazia is currently pursuing further analyses of this data to elucidate potential signals for further consideration.

Based on the totality of data available from all completed paxalisib clinical studies in newly diagnosed unmethylated GBM patients, Kazia will request a meeting with the US Food & Drug Administration (FDA) to discuss the results and determine if a potential path to accelerated approval is appropriate for paxalisib.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Full data including secondary endpoints from the paxalisib arm of the GBM AGILE study is expected to be presented at a scientific meeting later this year.

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia.

Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are

KZIA...........................................https://stockcharts.com/h-sc/ui?s=KZIA&p=W&b=5&g=0&id=p86431144783

.40 breakout that is sweet $$