KZA kazia therapeutics limited

Six SP News Drivers - Next 6 Months

  1. 2,142 Posts.
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    Important ASX announcements drive the share price - most would agree with that.

    Market sensitive announcements for KZA........(or anything much else really), despite all their current mid stage FDA Trials, have actually been few and far between, in recent times.

    - sure we had Phase 11 Paxalisib Interim data on 7/4/20... but those results were "killed off" by a major CR announced on the same day . A muted "Cantrixil Last Patient Visit" announcement on 17/4 contained data, but just 10 days post the CR was also smothered by the additional shares.

    So thats about it for investors, until you go back to 11th Dec 2019... "Kazia joins GBM Agile" and real data way back on 25 Nov 2019 with the a Paxalisib poster that showed some efficacy results, in 9 patients.

    So what is the point in above comments : ..... and then some imminent possible announcements from the company.

    In the 9 patient Paxalisib poster (the last time a data release was unencumbered - we saw absolute SP explosion with violent trading in the US , that saw the SP up 250% in an hour, subsequently over here, it gapped nearly 100% the next working day.

    Question is/ Pont is : What SP movement, may we see upon announcement of any of "my" six, without a CR overhang.

    At the very least, the SP has reached a stage of day to day, hold your breath type excitement I think, I hope.

    ------------------------------

    So my six, in the next 6 months - - no great surprise, but ALL, big impact news.


    1. Dana Farber Brain Mets Phase 2 Data.


    2. GBM Agile Confirmation.


    3. Company "blue sky" detailed explanation. Does KZA drug also work outside the Brain.


    4. Additional trials - possibility in a combo FDA Phase 3.


    5. DIPG St Jude Clinical Trial data.


    6. Early FDA approval application notification or advice from the Company.


    So some massive SP drivers are imminent finally

    .....just on the last one, which I regard as having the highest SP impact, this from another broker - NDF 4th April 2018. I think the possibility of an approach at the end of the current GBM Trial later this real is real.


    The GDC-0084 Phase 2 may allow early approval. In 2009 the FDA granted Genentech’s monoclonal antibody drug Avastin69 accelerated approval as a single agent for glioblastoma patients with progressive disease following prior therapy. The Agency did so mainly on the basis of a Phase 2 study called AVF3708g in 167 patients70 which showed an Objective Response Rate of 28%71. We believe, given the relative lack of a survival advantage for existing treatments, that GDC-0084 has potential to qualify for similar accelerated approval after the Phase 2, so long as it turns in a good number on the primary endpoint, which is Progression-Free Survival (PFS). Avastin’s PFS in recurrent glioblastoma is around 3.5 months7
 
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