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October 29, 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.
HIGHLIGHTS
- Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in combination with chemotherapy has been undertaken
- Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having been recorded along with four (4) unconfirmed PRs and five (5) SDs
- The median duration on trial is longer than for comparative trials of chemotherapy alone
- The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24 October 2024, 3 patients have been recruited
As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
- 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
- 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
- 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
- Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
- Median duration on trial at data cut-off is 136 days, which compares favourably with historical data for chemotherapy alone of 117 days
- Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
16h
Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer’s disease trial and interim analysis timeline
Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that the 100th participant in its pivotal XanaMIA phase 2b/3 randomized trial of Xanamem® for Alzheimer’s disease (AD) has now passed all screening tests and is scheduled for randomization and treatment in July. This establishes the timeline for the planned safety and efficacy futility interim analysis by an independent Data Monitoring Committee (DMC).
Highlights:
- More than 100 eligible participants are now enrolled in the XanaMIA AD trial, with the 24-week visit “trigger” for interim data analysis based on those participants occurring in late December 2025
- The DMC review of all available interim data will occur in January 2026 after which the results of the interim analysis will be announced
- Final trial results for 220 participants are anticipated in Q4 2026.
The DMC comprises independent clinical and statistical experts who are not connected to the day-to-day conduct or analysis of the trial. The committee will review, in a highly confidential process, unblinded data for safety and efficacy futility from all available participant visits including many who will have completed the 36- week treatment period.
“Unblinded data” refers to data tables, figures and listings where the assignment of participants to Xanamem or the placebo control treatment will be known only to the DMC members. It will then make a recommendation to the Company about the continuation and conduct of the trial without disclosing details of the data review.
While Xanamem’s safety is carefully monitored throughout the trial in an ongoing process, DMC review of unblinded safety data will add a significant amount of additional information to ensure the conduct of the trial is optimal.
An “efficacy futility” analysis will review key efficacy endpoints to ensure that the eventual outcome of the trial is not futile according to customary analytic methods for DMC reviews of this type. The DMC may not stop the trial early for ‘success’ and would recommend stopping the trial only if the futility criteria are met or there are major safety concerns. Actinogen believes that fully enrolling the 220 planned participants will ensure that the safety and efficacy of oral Xanamem 10 mg daily will be robustly demonstrated and as a result support the earliest possible regulatory approval of the drug.
During the second half of 2025, the Actinogen clinical, nonclinical, manufacturing and regulatory teams will meet with the US FDA1 to discuss the detailed potential pathways to FDA approval of Xanamem for Alzheimer’s disease, including expedited pathways should the XanaMIA trial show much stronger efficacy and safety than currently available treatments. As a base case, Actinogen is planning its regulatory approval pathways according to “conventional” oral therapy guidelines for important and common diseases such as AD. The next, phase 3 stage of development may involve one or more commercial partnerships to assist in trial conduct, regulatory submissions and commercial launch preparation.
Oral Xanamem is a unique treatment approach that targets control of cortisol levels in brain regions relevant to memory and cognitive function where the 11-β HSD1 enzyme is highly expressed. It has the potential to be used alone or in combination with other approved treatments because of its low drug interaction potential and the ease and convenience of a once-daily pill.
Summary of Xanamem’s Alzheimer’s disease program timeline:
- H2 2025 – FDA meeting to review planned program for US regulatory approval
- Q4 2025 or January 2026 – Full enrolment of 220 XanaMIA phase 2b/3 trial participants
- January 2026 – Independent DMC review of safety and efficacy data for XanaMIA
- Q1 2026 – Open-label extension trial enrols the first patient following on from XanaMIA
- Q4 2026 – Final XanaMIA results announced
- Q1 2027 – Commencement of second pivotal, phase 3 trial.
Actinogen Chief Executive Officer, Dr Steven Gourlay, said:
“We are delighted to confirm the timeline for our independent Data Monitoring Committee review of safety and efficacy data based on the enrolment of the 100th patient in the XanaMIA phase 2b/3 Alzheimer’s trial. This confidential review of unblinded data will ensure the XanaMIA trial is on-track and that Xanamem continues to perform as a promising and well-tolerated, once-a-day oral therapy.”
“Furthermore, with our 35 Australian and US clinical sites now enrolling at full pace, we are able to reconfirm our guidance for final results in late 2026. The availability of a follow-on, open-label trial where all will receive active Xanamem therapy should give participants and their families more incentive to participate in the current XanaMIA trial as well as provide valuable long-term safety and efficacy data.”
Click here for the full ASX Release
This article includes content from Actinogen, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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18 June
Medibank to Fund Emyria’s PTSD Program at Perth Clinic
Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) a leader in developing and delivering innovative mental health treatments, is pleased to announce that Medibank Private Limited (“Medibank”), Australia’s largest private health insurer, has commenced funding for eligible customers to access Emyria’s Empax PTSD care program delivered in association with Perth Clinic.
Key Highlights:
- Medibank (ASX: MPL) to fund eligible customer participation in Emyria’s Post-Traumatic Stress Disorder (PTSD) care program through Perth Clinic, with no out-of-pocket costs 1.
- Medibank is Australia’s largest health insurer supporting over 4.2 million customers.
- Agreement is multi-year and marks the first major private health insurance funding of a psychotherapy-led PTSD program in Australia.
- Strong validation of Emyria’s Empax Model, which integrates psychiatrist-supervised therapy, care coordination, and real-world data capture.
- Emyria’s ambition is to scale a sustainable, data-generating mental health platform nationally, building on initial program at Perth Clinic.
- Firm bids received from new and existing sophisticated and professional investors for a Placement of $4M (before costs) at $0.024 per share, including Director Participation of $197,000 (subject to shareholder approval).
This multi-year agreement enables eligible and screened Medibank customers to receive Empax’s comprehensive psychological trauma care program once admitted to Perth Clinic 2, reducing a major barrier to access for those with complex mental health conditions.
The psychotherapy program is now live and accessible by eligible customers. There are no minimum or maximum patient quotas. Due to the individualised nature of the treatment the associated cost per customer will vary according to clinical requirements.
A Clinically Rigorous and Integrated Care Model
Emyria’s Empax Model combines psychiatrist-supervised psychotherapy, specialist care coordination, and real-world data monitoring. Each patient undergoes a personalised course of treatment tailored to their needs.
Key components include:
- Psychiatrist-led, and ethics-endorsed care protocols delivered by trained clinicians;
- Rigorous patient selection and screening planning;
- Fit-for-purpose treatment environments;
- Strong clinical governance frameworks;
- Integrated data capture and analysis to support continuous improvement, and;
- Durable real-world outcomes. 3
While individual treatment plans differ, similar programs delivered by Emyria typically involve a course of care valued between $20,000 and $30,000.
Delivering Advanced Mental Health Care Nationally Under the Empax Model
The partnership with Medibank reflects growing recognition of the urgent need for better mental health treatments and positions Emyria as a national leader in advanced psychological trauma care. It also demonstrates how Emyria’s integrated care model can align with hospital infrastructure and insurer funding to deliver scalable, measurable care.
Emyria Executive Chairman Greg Hutchinson said that Medibank’s commitment to funding new mental health initiatives, including innovative psychotherapy programs, underscores the huge need for funding in this previously under-represented area of healthcare.
“Whilst we’ve seen great advances in many areas of medicine over the past 20 years, mental health incidence and prevalence have increased to unacceptable levels. It’s clear that mental health requires not just more resources, but a multi-faceted, multi-stakeholder and more innovative approach.
We commend Medibank for their leadership in funding new mental health initiatives, support that will expand access to promising therapies for more Australians suffering with complex and persistent mental health challenges”.
Click here for the full ASX Release
This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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12 June
HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard
Common Shareholder Questions – Entitlement Offer
HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.
- Global Breakthrough: In a world-first exclusive, HITIQ secures an exclusive global agreement with Shock Doctor, the #1 global mouthguard brand, to provide a self-fit “boil and bite” mouthguard design incorporating PROTEQT instrumented technology revolutionizing the ease of use of cutting edge PROTEQT concussion management technology.
- Unmatched Partnership: Shock Doctor’s world-class mouthguard design expertise unites with HITIQ’s advanced sensor technology to deliver a game-changing safety solution. This agreement enables HITIQ to scale PROTEQT’s commercialisation globally, with plans to manufacture 20,000 units in 2025 and 100,000 units in 2026.
- Ready for Athletes: The co-branded mouthguard with the PROTEQT system, now in production, rolls out to community sports through partnerships with VAFA, AFL Barwon, and Westfield Sports High, with more to come.
Shock Doctor: The Ultimate Mouthguard Partner
Shock Doctor is the only company with the expertise, infrastructure and scale to provide a self-fit mouthguard that can integrate HITIQ technology thus enabling reliable worldwide distribution. The co- branded PROTEQT mouthguard, featuring HITIQ’s PROTEQT logo and Shock Doctor’s “SHOCK” branding, integrates advanced impact sensors into a high-performance design, setting a new global standard for athlete safety.
Left image: The PROTEQT HITIQ/SHOCK co branded instrumented mouthguard. Right image: Market ready PROTEQT concussion management system
PROTEQT: Redefining Safety, PROTEQT’s concussion management system detects head impacts, assesses risks, and guides recovery with precision, backed by a 7-day telehealth service using the Sports Concussion Assessment Tool (SCAT). Built on HITIQ’s proven Nexus iMG technology, validated by elite partners like the AFL and NRL, PROTEQT is ready to protect community athletes worldwide. Strategic partnerships with VAFA (HITIQ’s Official Concussion Technology Partner), AFL Barwon, and Westfield Sports High ensure rapid adoption, with more collaborations in development.
Global Impact, Unmatched Scale Shock Doctor’s design and production partner prowess enable PROTEQT’s rapid production at affordable price points, with production trials confirming a robust supply chain. This exclusive global agreement, built on World Rugby’s approval and a U.S. patent for HITIQ’s Nexus technology, positions PROTEQT as a global leader in athlete safety.
Leadership Vision
Earl Eddings, Executive Chair, HITIQ: “This world-first global agreement with Shock Doctor, the global mouthguard leader, is a defining moment. PROTEQT, now market-ready, combines our cutting-edge technology with their mouthguard excellence to transform concussion management worldwide.”
Jay Turkbas, SVP Product Development: Shock Doctor, Inc. It was a welcome challenge developing and producing the physical structure to house HITIQ’s sensor technology. Paired with Shock Doctor’s world-class design and development expertise we are proud of this groundbreaking mouthguard solution allowing HITIQ to provide PROTEQT technology that can redefine athlete safety globally.”
Click here for the full ASX Release
This article includes content from HITIQ Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here
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05 June
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems
HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device designation for its Aortic Stenosis (“AS”) ECG algorithm.
Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. If unrecognized, AS can cause irreversible myocardial damage and significant deterioration in cardiac function.
The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' MyoVista Insights™ cloud-based platform which would directly integrate with hospital electronic health record (“EHR") systems, requiring no additional hardware or testing. This technology provides several key clinical advantages:
- Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS.
- Real-time or retrospective analysis using existing ECG data already captured during routine care.
- Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.
The algorithm was developed using advanced convolutional neural network (CNN) deep learning techniques and trained on more than 120,000 ECG records. In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy (AUROC) increasing as the disease progressed.
This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Vaid.
"Receiving FDA Breakthrough Device Designation marks another significant milestone for HeartSciences," said Andrew Simpson, CEO of HeartSciences. "By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected—leading to earlier referrals, better treatment pathways, and ultimately, improved lives."
About HeartSciences
HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve ECG’s clinical utility. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and intends to provide these AI-ECG algorithms on a device agnostic cloud-based solution as well as a low-cost ECG hardware platform. Working with clinical experts, HeartSciences ensures that all solutions are designed to work within existing clinical care pathways, making it easier for clinicians to use AI-ECG technology to improve their patient's care and lead to better outcomes. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test.
For more information, please visit: https://www.heartsciences.com. X: @HeartSciences
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2024, filed with the SEC on December 16, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2025, filed with the SEC on March 13, 2024 and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Investor Relations:
Integrous Communications
Mark Komonoski
Partner
Phone: 877-255-8483
Email: mkomonoski@integcom.us
Media Contact:
HeartSciences
Gene Gephart
Phone: +1-682-244-2578 Ext. 2024
Email: info@heartsciences.com
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20 May
Exclusive UK Packaging Agreement signed between Sharpak Aylesham Limited, Zoono, and OSY
Zoono Group Limited (Company) (ASX: ZNO) is pleased to update the market on an exclusive contract signed with Sharpak Aylesham Limited (Sharpak) and the Company’s partner in the food supply chain sector, OSY Group Limited (OSY).
Background
When, around three years ago, the Company's traditional markets for anti-microbial products were decimated by over-supply problems and dwindling public sentiment, the Board made a decision, of necessity, to focus on the pursuit of niche sectors which it believed suited the characteristics of its products and where significant sales opportunities existed. One such sector, introduced to Zoono by OSY, was the food supply chain sector and, in particular, the application of the Company's products to food packaging for the purpose of extending food shelf-life and reducing food waste, a challenge for supermarkets and food producers across the globe.
In conjunction with OSY (Zoono's partner in this project) and following nearly three years of testing and promotion of its shelf-life extension products and technologies, Zoono is pleased to announce that it and OSY have signed an exclusive agreement with Sharpak (the UK division of a leading European manufacturer of packaging solutions for the food industry - see below for further details on Sharpak).
The agreement builds on the Company's platform in the UK & EU food shelf-life extension market, via advanced trials with multiple leading supermarkets and international food producers. One leading UK premium supermarket has endorsed the technology’s status as a “game changer” in the industry due to its unique ability to be applied to a wide range of products and packaging types.
Sharpak's operations in the UK supply a large market share of the packaging of soft fruits sold by UK supermarkets, with its packaging also used for a broad cross-section of fresh produce and other food categories including meat and poultry.
Material Contract Terms
Sharpak has signed an exclusive contract with Zoono and OSY to use the Company's shelf-life extension products and OSY's application technologies on its food packaging ranges for soft fruits sold to major UK supermarkets.
Click here for the full ASX Release
This article includes content from Zoono Group, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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15 May
Accent Trial Data Demonstrates that Narmafotinib + Chemotherapy Combination Superior to Chemotherapy Alone
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce important new data from our ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane. Fifteen (15) confirmed partial responses (PRs) have now been recorded in the trial, a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone.
HIGHLIGHTS
- Key milestone achieved, with 15 confirmed responses recorded in the ongoing Phase 1b/2a ACCENT trial
- Sufficient confirmed responses have now been recorded to demonstrate that narmafotinib combined with chemotherapy is superior to chemotherapy alone.
- The ACCENT trial is evaluating narmafotinib in combination with the chemotherapies gemcitabine and Abraxane® in patients with advanced pancreatic cancer
- Narmafotinib is a highly potent and selective FAK inhibitor discovered at the Melbourne-based Cooperative Research Centre for Cancer Therapeutics.
- Phase 2a ACCENT trial is fully recruited with top-line data expected in mid Q3 2025
A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected. As pancreatic cancer is highly aggressive it is extremely rare for patients to achieve a complete response (CR).
The ACCENT trial is an open-label study meaning that all patients on the study receive narmafotinib in combination with the standard-of-care therapy. The data obtained in this trial is compared to historical data for the combination of gemcitabine and Abraxane in pancreatic cancer, and specifically data from the MPACT study, upon which we have closely modelled our trial1.
At the outset of the study a statistical analysis was performed which identified that a patient cohort of 50 patients would be sufficient to allow the efficacy of our combination to be ascertained with reasonable confidence if 15 or more responders (confirmed PR or CR) were recorded. A total of 55 advanced pancreatic patients have enrolled in the study since January 2024, with 21 patients still on study at this time.
As noted in our recent press release2, the drug continues to be well tolerated by patients with the rate and type of adverse events for the narmafotinib combination being similar to that reported for chemotherapy alone.
Amplia CEO and MD Dr Chris Burns commented: “We are extremely excited to have now recorded 15 confirmed partial responses in the ACCENT trial, demonstrating the benefit of adding narmafotinib to standard-of-care chemotherapy. With over 20 patients still on study we are hopeful that further PR’s will be observed”
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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