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Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
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Kazia Therapeutics (KZIA - Free Report) is an Australia-based clinical-stage company focused on developing drugs targeting oncology indications.
In the past week, the company’s shares have skyrocketed 489.6%. This upside came after management reported encouraging data from an investigator-led phase II/III study (called GBM AGILE) evaluating Kazia’s lead drug paxalisib against the standard of care (SOC) in patients with glioblastoma (GBM).
The study enrolled a total of 313 newly diagnosed unmethylated (NDU) patients and recurrent patients who were randomized in Stage 1 to either receive paxalisib or concurrent SOC.
A prespecified secondary analysis in NDU patients showed that patients who received the drug achieved a median overall survival (OS) of 15.54 months compared with 11.89 months in the control arm. The results showed a 3.8-month improvement (nearly 33%) in OS for newly-diagnosed NDU patients, which is a difficult-to-treat GBM population.
A prespecified sensitivity analysis in NDU patients also showed a similar median OS difference between paxalisib-treated patients and concurrent SOC patients.
Management also stated that the above results were consistent with the previously reported Kazia-sponsored mid-stage study, where paxalisib-treated patients achieved a median OS of 15.7 months compared with 12.7 months in patients receiving temozolomide chemotherapy.
In August 2022, Kazia announced that paxalisib did not meet the requirements to advance to the next stage of the GBM-AGILE study. At that time, the company couldn't analyze the reasons for this setback because they were unaware of the specific results.
Based on the above analysis, Kazia is planning to request a meeting with the FDA to seek a potential pathway for the drug’s accelerated approval.
Originally developed by Roche’s Genentech, paxalisib targets a key molecule in cell growth (PI3K) that's often out of control in cancer. Unlike many other drugs in this class, paxalisib can penetrate the brain, making it a promising treatment for brain cancers.
Year to date, Kazia’s shares have surged 182.2% year to date against the industry’s 5.1% fall.
Image Source: Zacks Investment Research
However, the results of the primary analysis were not as encouraging, with data showing a median OS rate of 14.77 months for paxalisib in NDU patients compared with 13.84 months for SOC.
The drug also did not fare any better compared with SOC in recurrent disease patients, where paxalisib-treated patients achieved a median OS of 8.05 months compared with 9.69 months for concurrent SOC. Management stated that it will further analyze this data to identify any potential signals for further consideration.
The GBM AGILE study, which is sponsored by the Global Coalition for Adaptive Research (GCAR), is evaluating multiple therapies for glioblastoma. Kazia’s paxalisib is the third drug to complete enrolment in the study. The GBM AGILE study is also evaluating multiple other novel investigational therapies, which also include those developed by Bayer, Kintara Therapeutics, and Biohaven Pharmaceuticals.
Zacks Rank & Key Picks
Kazia carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) , Compugen (CGEN - Free Report) and Heron Therapeutics (HRTX - Free Report) . While CGEN sports a Zacks Rank #1 (Strong Buy), ARQT and HRTX carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Compugen’s 2024 earnings per sharehave risen from 2 cents to 5 cents. During the same period, loss estimates per share for 2025 have improved from 27 cents to 11 cents. Year to date, CGEN’s shares have lost 11.6%.
Earnings of Compugenbeat estimates in three of the last four quarters while missing the mark on one occasion. CGEN delivered a four-quarter average earnings surprise of 5.79%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.22 to $1.60. During the same period, the loss estimates per share for 2025 have narrowed from $1.37 to $1.14. Year to date, shares of Arcutis have surged 232.2%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per share have narrowed from 14 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 2 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 94.7%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.
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Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
Kazia Therapeutics (KZIA - Free Report) is an Australia-based clinical-stage company focused on developing drugs targeting oncology indications.
In the past week, the company’s shares have skyrocketed 489.6%. This upside came after management reported encouraging data from an investigator-led phase II/III study (called GBM AGILE) evaluating Kazia’s lead drug paxalisib against the standard of care (SOC) in patients with glioblastoma (GBM).
The study enrolled a total of 313 newly diagnosed unmethylated (NDU) patients and recurrent patients who were randomized in Stage 1 to either receive paxalisib or concurrent SOC.
A prespecified secondary analysis in NDU patients showed that patients who received the drug achieved a median overall survival (OS) of 15.54 months compared with 11.89 months in the control arm. The results showed a 3.8-month improvement (nearly 33%) in OS for newly-diagnosed NDU patients, which is a difficult-to-treat GBM population.
A prespecified sensitivity analysis in NDU patients also showed a similar median OS difference between paxalisib-treated patients and concurrent SOC patients.
Management also stated that the above results were consistent with the previously reported Kazia-sponsored mid-stage study, where paxalisib-treated patients achieved a median OS of 15.7 months compared with 12.7 months in patients receiving temozolomide chemotherapy.
In August 2022, Kazia announced that paxalisib did not meet the requirements to advance to the next stage of the GBM-AGILE study. At that time, the company couldn't analyze the reasons for this setback because they were unaware of the specific results.
Based on the above analysis, Kazia is planning to request a meeting with the FDA to seek a potential pathway for the drug’s accelerated approval.
Originally developed by Roche’s Genentech, paxalisib targets a key molecule in cell growth (PI3K) that's often out of control in cancer. Unlike many other drugs in this class, paxalisib can penetrate the brain, making it a promising treatment for brain cancers.
Year to date, Kazia’s shares have surged 182.2% year to date against the industry’s 5.1% fall.
Image Source: Zacks Investment Research
However, the results of the primary analysis were not as encouraging, with data showing a median OS rate of 14.77 months for paxalisib in NDU patients compared with 13.84 months for SOC.
The drug also did not fare any better compared with SOC in recurrent disease patients, where paxalisib-treated patients achieved a median OS of 8.05 months compared with 9.69 months for concurrent SOC. Management stated that it will further analyze this data to identify any potential signals for further consideration.
The GBM AGILE study, which is sponsored by the Global Coalition for Adaptive Research (GCAR), is evaluating multiple therapies for glioblastoma. Kazia’s paxalisib is the third drug to complete enrolment in the study. The GBM AGILE study is also evaluating multiple other novel investigational therapies, which also include those developed by Bayer, Kintara Therapeutics, and Biohaven Pharmaceuticals.
Zacks Rank & Key Picks
Kazia carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) , Compugen (CGEN - Free Report) and Heron Therapeutics (HRTX - Free Report) . While CGEN sports a Zacks Rank #1 (Strong Buy), ARQT and HRTX carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Compugen’s 2024 earnings per sharehave risen from 2 cents to 5 cents. During the same period, loss estimates per share for 2025 have improved from 27 cents to 11 cents. Year to date, CGEN’s shares have lost 11.6%.
Earnings of Compugenbeat estimates in three of the last four quarters while missing the mark on one occasion. CGEN delivered a four-quarter average earnings surprise of 5.79%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.22 to $1.60. During the same period, the loss estimates per share for 2025 have narrowed from $1.37 to $1.14. Year to date, shares of Arcutis have surged 232.2%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per share have narrowed from 14 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 2 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 94.7%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.