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The site will be located at Sportsmed Biologic in Melbourne, and directed by specialist sports physician Dr Phillip Bloom, who has more than two decades of clinical experience in osteoarthritis management.

This will be the first of 11 Australian sites earmarked for participation in the PARA_OA_012 study. Paradigm has also received informed consent from its first Australian patient, who will take part in the trial.

Alongside the Oz component, there will also be 48 sites in the States that are currently in advanced preparations for activation under the centralised ethics approval.

Managing director Paul Rennie said these were significant milestones for the Paradigm.

“The activation of our first site in Australia and the consenting of our first patients in Australia, with the US soon to follow, mark a significant operational achievement for the company,” Mr Rennie said.

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He continued: “I am particularly pleased to see the high level of engagement from leading clinical investigators and trial sites.

“I am also pleased that the company is progressing in line with our intended schedule.”

PAR has been trading at 30.5 cents.

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The company unveiled its financial report for the year ending March 31, telling investors its full-year operating revenue had risen 6% to $208M. This was underpinned by an 11% rise in product sales and royalties across all territories, along with $0.7 million worth of income from licensing.

Group revenue was boosted by sales growth in the Australian and New Zealand markets, up 17% and 10% respectively. In Australia, this increase was offset by the one-off factors of destocking and interruptions to demand for Maxigesic IV.

In Oz, the operating profit was also in good shape, with an increase of 65%.

With this variable considered in the medium term, AFT has now set the goal of reaching $300M in revenue by the end of the 2027 fiscal year.

Earnings for the year were in a slightly weaker position, with EBITDA (earnings before interest, taxes, depreciation and amortization) falling 20% to $20.9M while operating profit fell 27% to $17.6 million – in line with guidance released at the half year – and net profit after tax was down 23% to $12M.

AFT co-founder and managing director Dr Hartley Atkinson said the company had already achieved multiple goals during the 2025 fiscal year.

“Aside from continued strong growth in our core Australasian businesses, we have significantly advanced strategy to extend our reach across multiple geographies and added to our research and development pipeline,” AFT’s boss explained.

Highlights included launching Maxigesic tablets in the U.S., the launch of a proprietary antiseptic cream in mainland China, and the completion of multiple licensing agreements around the world, including Maxigesic IV in China and Brazil, Mr Atkinson flagged.

“These efforts have come at the cost of short-term earnings growth, but we are convinced they will deliver growth in long-term shareholder value.”

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Mr Atkinson added: “In a credit to our out-licensing activities, we were identified as the only company in the world last year to secure two licensing agreements into China, the world’s second largest pharma market.”

AFP shares have been trading at $2.55.

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The impact of Trump’s announcement – made on Truth Social on Sunday – could be observed in general terms, with Health Care being the worst performing sector on the ASX, down 1.17% on a mixed trading day.

Unsurprisingly, a cluster of companies followed the trend, with Neuren Pharmaceuticals, Telix Pharmaceuticals and Clarity Pharmaceuticals being noted as some of the bourse’s worst-performing stocks early on in the session, dropping 8.05%, 8.04% and 7.20% respectively by 14:25 AEST.

In his social media post, Trump said he wanted to bring prescription drug prices in the United States into line with those in other high-income countries, and promised he would sign an executive order to that effect on Monday.

Although he did not provide much detail about how the pricing would be shifted, the President said his policy would drive towards a ‘most favored nation’ framework, with prices to drop by between 30% and 80%.

“They will rise throughout the World in order to equalize and, for the first time in many years, bring FAIRNESS TO AMERICA!” he said.

“I will be instituting a MOST FAVORED NATION’S POLICY whereby the United States will pay the same price as the Nation that pays the lowest price anywhere in the World.”

As it is now, customers in the US pay the highest prices in the world for many prescription drugs.

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The trial’s Safety Review Committee (SRC) has looked at cumulative safety and pharmacokinetic data – including from the second dosed cohort of participants – and concluded that there are no issues.

This means Nyrada can proceed to the third cohort, for which it is already recruiting participants. It is expecting final readouts for the Phase 1 trial to be completed by the third quarter of the 2025 calendar year.

The company’s expectations for NYR-BI03 have been bolstered by positive newsflow throughout much of last year and into 2025, starting with an announcement in February 2024 that preclinical stroke study results had shown the candidate had achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.

This was followed by a preclinical study into coronary heart disease in October which revealed NYR-BI03 providing an 86% cardioprotective effect following myocardialischemic-reperfusion injury, a leading cause of tissue damage when blood flow is restored to the heart after injury.

Finally, last month Nyrada told investors about the results of a preclinical traumatic brain injury study which indicated a statistically significant (p = 0.043) neuroprotective effect provoked by NYR-BI03 following a penetrating traumatic brain injury.

The study in question was undertaken in collaboration with the Walter Reed Army Institute of Research and UNSW Sydney.

Nyrada has been trading at 11 cents.

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The retail move into Singapore was of particular importance, with initial stocks of Nasodine distributed to specific Guardian pharmacies in January.

This increased to 54 pharmacies the following month, including five new openings at Changi airport and a virtual training course for Guardian pharmacies marketing the product.

By the end of March, up to 125 pharmacies in Singapore are now selling Nasodine, supported by a range of marketing and in-store promotions organised through Firebrick’s marketing partner, Innorini Life Sciences.

Firebrick also reported marketing success in the U.S. where online orders grew 44% in the third quarter and were up 135% compared to first-quarter hauls.

Alongside this, Q3 unit sales have reportedly increased 81% compared to Q2 and 203% compared to Q1, with these figures reflecting the increasing underlying adoption of Nasodine in the U.S. A paid influencer marketing program which ran from December to January also helped, as did a “buy one, get one free” program which was offered between January and March 2025.

Expansion into other markets was also a watchword; Firebrick executed a License and Distribution Agreement with Makans covering Fiji and the South Pacific.

The company also continued major preparations for its launch into the Philippines.

The latter included the manufacture in February of Nasodine at Hizon Pharmaceuticals in Manilla, under Firebrick’s supervision.

The resulting product will receive stability testing for six months (expected for completion by August) followed by the completion of a registration dossier.

Once these test results come in, they should enable Firebrick’s licensing partner SV More to file for approval of Nasodine by the Philippines Food and Drug Administration (PFDA), opening the door to a launch in mid-2026.

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Financial news was also positive for the company during the March quarter: It secured a $1.1 million strategic investment from Pharma Nutria N.A., Inc., an entity that forms part of the SV More Group of Companies, including Firebrick’s Philippines licensing partner, SV More Pharma Corporation.

FRE has been trading at 7.9 cents.

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Emyria aims to expand its provision of programs supporting patients with PTSD and treatment-resistant depression – including through psychedelic-assisted therapies – by 50%.

The first two fully funded patients will commence treatment on April 14, with this underscoring the activation of the Perth Clinic site and the company’s intention to roll out a broader strategy to meet clinical demand.

The latter also reflects structural changes in mental health care funding.

The centre’s location in a licensed facility is to ensure Emyria meets the requirements of payers set to fund Empax treatment. The company is now looking to potential expansion of ‘Empax’ into the eastern states.

“We are responding to growing patient demand and the expectations of major health funders,” Emyria executive chair Greg Hutchinson explained.

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He continued: “Our expansion into licensed hospital settings demonstrates Emyria’s capacity to deliver scalable, evidence-based mental health care treatments.”

EMD has been at 3cps – a rise of 3.45% since the market opened today.

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All patients had been confirmed as having had large vessel occlusion strokes and undergoing an endovascular thrombectomy procedure to remove the clot. Of these, half received an intravenous infusion of a saline placebo, while the other half received an intravenous infusion of ARG-007.

Until the last patient has their follow-up functional assessment – 90 days post-stroke – the trial will remain ‘blind,’ meaning none of the people involved in dosing or follow-up assessments will be told what treatment each patient received.

Once this final functional assessment is complete, data will be unblinded and analysed to assess the trial’s ability to meet its endpoints.

Argenica anticipates the release of its topline data in Q3 calendar year 2025.

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The first endpoint for the ongoing tests involves the assessment of the drug candidate’s safety, when issued in one dose to a person with acute ischaemic stroke – examining mortality rate, incidence of serious adverse events, and incidence of symptomatic intracranial haemorrhage.

Additionally, the company will look at the effect of ARG-007 on reducing infarct volume in participants with acute ischaemic stroke.

AGN has been trading at 67 cents early on Friday morning.

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The placement involves a commitment from a private investor based in Australia, and the issue of around 17.9 million new fully-paid ordinary Recce shares, to be priced at 28 cents each for a total of $5 million.

The company also launched an entitlement offer of one new share for every six fully paid ordinary shares held by eligible Recce shareholders.

That price will be the same as the placement; the goal there is to raise $10.8M.

Recce plans to use the Placement funds to drive completion of one of its Phase III topical clinical tests, while funds from the Entitlement offer will go towards the progression of other development programs.

The former relates to the Phase III DFI Registrational Topical Clinical Trial in Indonesia – which is expected to bring in revenue in 2026.

Also related is the Phase III Acute Bacterial Skin and Skin Structure Infections Registrational Topical Clinical Trial in Australia, which is commencing soon.

“We’re delighted to receive further support from an existing Australian-based shareholder and are pleased to launch an entitlement offer to all shareholders to acquire new shares at the same price,” CEO James Graham said.

The funding, he added, now gives Recce an important injection to build future plans.

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He continued: “Proceeds from the capital raising will be used to support a Registrational Phase III clinical trial for Diabetic Foot Infections in Indonesia and a Registrational Phase III for ABSSSI across Australia, following a recently announced Phase II ABSSSI clinical study achieving all endpoints.”

Mid-arvo, Recce was trading at 29.5cps after a 9.23% drop.

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Nyrada is working with the Walter Reed Army Institute of Research and the University of New South Wales on the project, which revealed that NYR-BI03 could prevent secondary brain injury following a penetrating traumatic brain injury.

This was confirmed through MRI imaging conducted at the university, which confirmed statistically significant neuroprotection (p = 0.043) for NYR-BI03.

WRAIR – a globally significant military medical research institution that is part of theU.S. Army – provided an established penetrating TBI model involving 28 test animals,which received continuous intravenous infusion of either NYR-BI03 or a vehicle control, over48 hours.

Chair of the Scientific Advisory Board (SAB) and UNSW Scientia Professor Gary Housley said these results were significant. “This study provides strong evidence that Nyrada’s NYR-BI03 drug protected the brain following severe TBI.”

“This was determined using a new MRI approach for quantifying brain tissue integrity.”

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At the same time, Nyrada is progressing NYR-BI03 – a first-in-class TRPC 3/6/7 blocker with a novel mechanism of action – through a Phase I clinical trial to assess its safety and tolerability.

Readouts are expected in the third quarter of the 2025 calendar year.

Nyrada shares have been trading at 9.3 cents.

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The study analysed the effects of the drug candidate on Tessara’s RealBrain 3D human tissues model – a 3D model of the brain – and found both NUZ-001 and NUZ-001 Sulfone (which was also included in this particular study) were safe when applied to a healthy human brain.

The two tested drugs also reportedly provided neuroprotective properties against neurotoxic insult (damage to the brain and nervous system caused by toxic substances) and encouraged the health of brain tissues.

Additionally, they may potentially boost neuronal branching, enabling neuroplasticity.

Tessara’s Principal Scientist Dr Mark Greenough will be presenting the results of the study at the AD/PD 2025 Advances in Sciences & Therapy Conference, with AD/PD being the most prestigious international conference addressing Alzheimer’s and Parkinson’s diseases. The conference will be held in Vienna.

Further research is being done to explore how the NUZ-001 Tessara’s ADBrain model might have therapeutic benefits for sporadic Alzheimer’s disease

Results on that front are expected this quarter, the company has today confirmed.

“These findings indicate short-term treatment with NUZ-001 and NUZ-001 Sulfone maintains an excellent safety profile in Tessara’s RealBrain micro-tissues,” Tessara’s managing director and CEO Dr Christos Papadimitrio said.

In addition, the compounds appear to offer neuroprotective effects against ferroptosisand encourage neural branching, potentially boosting plasticity by enabling neurons to form additional connections.

“While further research is needed to clarify the mechanisms responsible… data suggests longer-term treatment may enhance network density and plasticity.”

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“In humans, this could translate into tangible benefits in cognition, learning, memory, or resilience to neurodegenerative processes involved in diseases such as Alzheimer’s, Parkinson’s, and Amyotrophic Lateral Sclerosis.”

Neurizon shares have been trading at 13 cents this morning.

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The Phase I first-in-human trial is assessing NYR-BI03’s safety and tolerability as well as scrutinising its pharmacokinetics (how the body interacts with the drug).

All participants have now been dosed and discharged.

Of these, six received NYR-BI03 while two participants received a placebo.

Once each cohort is completed, the Safety Review Committee will review the accumulated data on safety and pharmacokinetics, with further dose cohorts only going ahead after favourable review and approval by the SRC.

This development follows Nyrada’s report in February 2024 of preclinical stroke study results, which indicated that the drug candidate was able to meet a statistically significant neuroprotective effect, achieving the rescue of 42% of brain tissue in the penumbra region of treated animals.

Later that year, in October 2024, the company reported on a preclinical coronary heart disease study which revealed an 86% cardioprotective effect produced by NYR-BI03 following myocardial ischemic-reperfusion injury – a significant cause of tissue damage that occurs when blood flow is restored to the heart after injury.

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Final Phase I trial readouts are now expected in the third quarter of 2025.

NYR shares last traded at 10.5 cents – a fall of 4.54% since the market opened.

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The headlining news is the HEALEY treatment period for the trial is being extended from 24 to 36 weeks to enable a longer evaluation of treatment effects.

The study will also be enriched for fast progressors, the company said, through a shift in the “show time for symptom onset,” from 36 to 24 months. On top of that, peripheral blood mononuclear cell collection has been added to aid future research and therapy development.

Neurizon also shared data showing its lead product, NUZ-001, has been slowing the decline in slow vital capacity; a key respiratory function and survival metric for ALS.

The analysis for this was undertaken by Berry Consultants, with their findings indicating SVC could be a secondary endpoint for NUZ-001.

Specifically, they found that treatment with NUZ-001 resulted in a 48% slowing in the loss of respiratory function for all 12 patients in the Phase 1 MEND Study – compared to untreated matched controls.

“Following a comprehensive review of the data from the first five completed regimens, HEALEY has implemented improvements to the HEALEY Master Protocol to maximise the potential for a positive outcome,” Neurizon’s managing director and CEO Dr Michael Thurn said after sharing the news.

“We were excited to learn about the strong correlation between reducing the respiratory function decline rate in patients treated with NUZ-001 and overall functional decline as measured by ALSFRS-R.

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“Having supporting positive secondary endpoints greatly increases the likelihoodof receiving accelerated approval.

“Over the coming months, the company will continue to work towards finalising participation in the HEALEY trial, with entry expected during H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA’s clinical hold.”

Neurizon shares have been trading at 10.5 cents.

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Research and development costs – mainly relating to clinical trials – accounted for the main expenditure item, with these costs being $4.58 million.

Actinogen reported a busy and successful year in terms of these trials, including ongoing progress in screening and enrolment for its XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial, and positive findings yielded from its completed XanaCIDD phase 2a major depressive disorder (MDD) trial.

Results from the latter included positive findings on depressive symptoms – with this supporting the theory that controlling cortisol can have clinical benefits.

The company is now looking to follow this up with a Phase 2b trial.

Other achievements during the period included the granting of a unique International Nonproprietary Name (INN) ’emestedastat’ to Xanamem by the World Health Organization, and the publishing of an academic paper in peer-reviewed journal, Clinical Pharmacology in Drug Development, related to its clinical trials.

Actinogen was also the recipient of a $9M Research & Development tax incentive rebate in November 2024, with its funding secured to mid-to-late 2026.

CEO and managing director Dr Steven Gourlay said it had been a busy six months.

“The first half of the 2025 financial year has seen ongoing strong business momentum for Actinogen with positive findings in patients with depression that validate Xanamem’s mechanism of action and 10 mg dose,” he said.

“We continue to step up recruitment in the XanaMIA Alzheimer’s trial with growing confidence in a positive outcome while putting the necessary ancillary activities in place to assess and meet regulatory requirements for future marketing approvals.”

Actinogen shares closed at 3.7c today; a fall of 9.76% through Monday.

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Company Executive Chair Dr Peter Molloy, who originally developed Betadine Sore Throat Gargle in Australia, has previously outlined to HotCopper why Nasodine is superior to other cold treatments.

So how is it different?

The compound is a germicide and not a decongestant or cough suppressant, meaning that unlike other cold treatment drugs, Nasodine actually targets the cause of the common cold.

Nasodine is ultimately a disease prevention and treatment product, standing out from the rest.

Molloy has long had a hunch a topical antiseptic applied to the nasal cavity would be not only be safer than taking pills, but also more effective.

So far, he says study data backs up this hunch.

Helpfully, the biotech company is ready to go full scale commercial – Nasodine Nasal Spray is already available in the US and more recently Singapore (in recent history, Firebrick has successfully defended its PVP-iodine based nasal spray patent in Singapore after a third party began to sell a similar product.)

The last time Molloy spoke to HotCopper, we looked at how the recent COVID-19 debacle had heightened awareness, for better or worse, of global disease spreading broadly (as well as governmental responses to such outbreaks).

We’d suggested we wouldn’t be far away from the next pandemic risk event – and that’s exactly what we’re looking at now, though it’s important to note the World Health Organisation (WHO) has not yet issued any kind of alert about the spread of the disease.

Enter China’s Human Metapneumovirus (HMPV). This is the latest disease to come from the world’s second largest economy. Fortunately, so far, we’re not seeing the same kind of rapid transmission or fatality rates we saw in late 2019.

However, the condition isn’t necessarily ‘new’. The HMPV virus was first isolated in 2001 and has appeared occasionally during various winter seasons. What’s new is the sudden growth in cases currently hitting China and elsewhere. Consider that it’s winter in many parts of the world.

The condition is similar to COVID-19 in that it produces flu-like symptoms, and just like COVID, flu and other respiratory viruses, it is spread mainly by airborne droplets. When an infected person breathes, coughs, or sneezes, droplets containing the virus are released into the air; tiny microdroplets can hang in the air for hours. Typically, you breathe in these droplets and become infected.

Here, Nasodine’s implications are obvious: it’s a germicide that is proven to kill HMPV in under 60 seconds in lab testing; when applied to the nasal passage it should protect you from the infection or at least stop it in the early stages.

So that’s Metapneumovirus. But it’s actually the United States of America where a more pressing threat is of concern.

Late last year, the first patient in the US to die of a recent bird flu outbreak was officially recorded. As of Friday, January 17, 2024, the American Center for Disease Control (CDC) cites 67 confirmed human cases.

But it’s the capacity for further spread to humans that is of greater priority than the treatment of those 67 patients. For while no person-to-person spread of bird flu has yet been recorded, the disease is prevalent in cattle across multiple states in the US.

Meanwhile, poultry flocks and mammals are vulnerable to ‘sporadic spreads’ from the wild bird population. And this is the biggest concern: The particularly strong bird flu strain ‘H5’ is currently considered ‘widespread‘ among wild bird populations in the US, according to the CDC.

What happens next remains to be seen, but if human to human transmission and a new pandemic ensues, Nasodine Nasal Spray is already available in the US and it promises to kill bird flu virus just as quickly as normal flu and HMPV – with no risk of resistance to Nasodine. With the ongoing parade of pandemic threats, a tappable market for Nasodine isn’t going anywhere anytime soon.

Seeing as we’re talking forward-looking, it’s both a mix of predictable and wholly speculative angles of what lies ahead for the Australian pharmaceutical (and biotech) space in CY2025.

It goes without saying we can expect to keep seeing ‘Artificial Intelligence’ (AI) remain a dominant theme as companies try to jam chatbots into everything and everything.

It also goes without saying Trump’s looming ‘2.0’ administration in the US is good news for believers in hands-off small government and conservative regulators. Robert F Kennedy’s appointment as health overlord has been quiet in the press lately, but there’ll be lots of eyes there.

One could easily envisage a shift away from Big Pharma vaccines as the sole acceptable solution for pandemics, with governments becoming more receptive to approaches previously shunned during the COVID era. One of these is Nasodine, which could find it itself readily deployed as a frontline pandemic defence, especially while vaccine development takes place. Stockpiling is not out of the question.

It may be a while before it’s available on Australian pharmacy shelves, but in the meantime, Australians can buy it online from Singapore, and, according to Firebrick Pharma, many of its shareholders have done so.

It’s sold in Singapore as a ‘nasal antiseptic’ for use while commuting, air travel or any other situation where someone feels concerned about airborne germs. That sounds like a concern that most of us share!

Firebrick Pharma last traded at 6.1 cents.

The tech sector is still riding high, but 2025 calls for sharper focus. The days of broad rallies are over—this year, it’s all about picking the stars among the crowd. Many tech favourites have already hit lofty valuations, so the real opportunities lie in quality businesses with robust earnings growth and groundbreaking innovations. Not every tech name will shine in 2025; the winners will be those who redefine the game.

All eyes are on the Reserve Bank of Australia, which is expected to cut interest rates this year. While May is the most likely timing, there’s chatter about a potential February move. Two rate cuts could deliver a major boost, making borrowing cheaper, igniting the property market, and enhancing bank profitability. However, the RBA won’t move without clear signs of economic cooling—its cautious stance remains tethered to a strong labour market.

Global dynamics are driving a surge in demand for resources, and the materials sector is poised to benefit. India’s rapid growth, China’s stimulus measures, and Trump’s pro-industry policies are fuelling optimism. Yet, it’s not without risks—U.S. tariffs on Chinese goods like lithium batteries could weigh on Australian exports so keep a close watch on these macro factors as you navigate the sector.

After years as the market’s underdog, the energy sector could surprise us in 2025. The expansion of AI and other energy-intensive technologies is driving renewed demand for traditional sources like coal and gas, even as renewables continue to gain traction. Geopolitical factors, OPEC decisions, and shifts in U.S. energy policy will add to the intrigue, making energy the wildcard to watch this year.

With opportunities across sectors and plenty of excitement ahead, 2025 promises to be a year of transformation and growth. Stay sharp, stay informed, and get ready to make this year your best investing year yet!

The best-performing sectors include Energy, up just under three per cent, followed by Materials, up over two per cent and Real Estate, up over one and a half per cent. The worst-performing sectors include Information Technology, down over three per cent, followed by Healthcare, down over two per cent and Consumer Discretionary, down over one per cent.

The best-performing stocks in the ASX top 100 include James Hardie, up over eight per cent, followed by Evolution Mining and Telix Pharmaceuticals, both up over seven per cent. The worst-performing stocks include HUB24 Ltd, down over nine per cent, followed by WiseTech Global and Pro Medicus, both down over five per cent.

This week, the All Ordinaries Index showcased resilience, with buyers stepping in on Thursday to erase early selling pressure, pushing the market up by just under half a per cent. In a week marked by a back-and-forth struggle, the index had dipped over 1 per cent by Wednesday before buyers rallied around the 8,400 level, lifting it back into positive territory.

The 8,400 level is particularly noteworthy, as it has been tested nine times on a weekly basis since mid-September. This consistent activity highlights strong buying interest at this level, suggesting that it serves as a significant support zone. However, it also points to the market finding comfort in this range, raising the possibility of a return to the sideways movement seen from September to November last year.

Despite this, the overarching trend remains bullish. The strong rebound from 8,400 has shifted focus to the 8,600 level. An earlier attempt to breach the 8,600 level last week was met with selling pressure, but if the index manages to break through on the next try, a test of the all-time high appears likely. Should that high be surpassed, the potential for the index to reach 9,000 points this year comes into play.

In fact, if the All Ordinaries continues its strong trajectory from 2024, a move to 9,200 could be entirely achievable based on historical averages. Of course, markets can be unpredictable, but as an investor, remember you’re not trading the index directly—you’re picking individual stocks.

Therefore, use the broader market’s momentum to your advantage, and always protect your positions with well-placed stop losses in case the tide turns.

For now, good luck and good trading.

Dale Gillham is the Chief Analyst at Wealth Within and the international bestselling author of How to Beat the Managed Funds by 20%. He is also the author of the bestselling and award-winning book Accelerate Your Wealth—It’s Your Money, Your Choice, which is available in all good bookstores and online at www.wealthwithin.com.au. 

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Results from a Phase 2a trial – reported in November – had shown ISLA-101 to be both safe and demonstrating ‘anti-dengue activity,’ leading the Safety Review Committee (SRC) to recommend trialling move on to the next phase.

While Phase 2a has concentrated on ISLA-101’s preventative arm, with a clinical trial involving four subjects randomised as 3:1 (active: placebo), Phase 2b will focus more on the therapeutic features of the drug, with 10 subjects randomised 8:2 (active: placebo).

To date, four of these subjects have been enrolled, and the second group of six is now expected within the next two weeks.

During the trial, they will be exposed to an attenuated strain of the virus and then administered either the placebo or ISLA-101 seven days later.

Island will primarily be looking for evidence of viremia (virus load in the bloodstream) reduction in subjects, although other endpoints will include confirming the safety of ISLA-101, and a reduction in the symptoms associated with dengue infection.

CEO and managing director Dr David Foster said the assessment of the drug was moving along promptly.

“We are excited to start the Phase 2b cohort right on schedule, following the strong datafrom our Phase 2a cohort and the subsequent recommendation by the SRC to move forward,” Mr Foster said.

“The SRC’s determination that there was evidence of antiviral activity in ISLA-101 treated subjects in the prophylactic setting was a landmark conclusion and we look forward to seeing if ISLA-101 may also be effective as a treatment in dengue-infected subjects.

“After an incredibly fruitful 12 months for the ISLA-101 clinical program, we look forward tocontinuing the momentum and exploring our lead drug candidate as a dengue therapeutic through the Phase 2b study.”

Island has been trading at 16 cents.

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According to the exclusive development and license agreement, FUSO Pharmaceutical Industries Ltd will acquire exclusive rights to develop, register, and commercialise DMX-200 in Japan, taking on all clinical trial costs within the country.

The candidate is currently in global Phase 3 clinical development, with a blinded interim analysis expected in August 2025.

Dimerix – which retains all commercialisation rights for DMX-200 in all territories otherthan those covered by its agreements with FUSO, Advanz Pharma, and Taiba – will receive up to ¥10.5 billion (A$1071M) in upfront, development, and sales milestone payments, as well as through royalties.

CEO and managing director Dr Nina Webster said Dimerix was pleased to enter this partnership for the development of the candidate in Japan.

“FUSO brings a wealth of experience in pharmaceutical development and sales and marketing across Japan, and with a proven record in sales and marketing products for patients with renal disease,” she said.

“This partnership reflects a confidence not only in the significant potential for DMX-200 in FSGS patients but also in Dimerix’s capabilities in the development of DMX-200.

“FUSO’s expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of developing and commercialising DMX-200 and bringing hope to those patients desperately in need of treatment options.”

Dimerix shares rose on the news, and at 10:35 AEDT, they were trading at 42.5 cents – a rise of 19.72% since the market opened.

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The data – to be presented at the 66th American Society of Hematology annual meeting (ASH) – was from Syntara’s Phase 2 clinical trial for the drug, which was tested in combination with ruxolitinib (RUX).

It showed a 50% improvement in Total Symptom Score (TSS50) among 46% of evaluable patients following 12 weeks of treatment, with this rising to an 80% improvement at 38 weeks of treatment.

TSS50 is a standard efficacy endpoint used as the primary endpoint in clinical trials related to MF.

Spleen reduction volume (SRV) was another factor of importance, with 30% of evaluable patients achieving an SVR of 25%, while 20% reported an SVR of 35%.

Notably, both this variable and patient symptoms continued to improve over the period under assessment: Differentiating SNT-5505 from MF currently on the market and in later stages of development.

Professor of myeloproliferative neoplasms at Guy’s and St Thomas’ NHS Foundation Trust Claire Harrison said the drug candidate was showing positive signs of effectiveness and safety under this trial.

“This interim data confirms the excellent safety profile of SNT-5505 and also suggeststhat the mechanism of SNT-5505 may exert a long-term effect on the disease, with bothsymptoms and spleen volume continuing to improve as we now see patients on drug for9 months,” she said.

“This hasn’t been seen before with this class of drug and holds potential for real long-term benefits for MF patients.

“I look forward to seeing the data mature in the coming months to confirm these important early findings.”

Syntara has been trading at flat at 6.7 cents.

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Two achievements have made this possible: The first being Recce’s gaining of approval from the Indonesian Drug and Food Regulatory Authority – Badan POM – for the Registrational Phase 3 clinical trial.

Alongside this, Recce’s human ethics committee has approved commencement of patient dosing, and the alignment of both means the trial is on-track to begin this quarter.

While extending its global therapeutic footprint is an important priority for any pharmaceutical company, one might ask why Recce has decided to launch a trial in Indonesia in particular.

In fact, the upward trend of diabetes in the country has been acknowledged as a serious health issue since the 1980s, and today it has one of the world’s largest patient populations for the condition.

Data from the International Diabetes Federation (IDF) has shown that, in 2021, 10.6% (or around 19 and a half million people) were affected by diabetes mellitus – the group of conditions associated with high blood glucose – in Indonesia. By 2030, this was predicted to grow to 11.3% of the population (accounting for more than 23 million people).

Crucially, the same data set indicated that in 2021, 73.7% of people with diabetes were undiagnosed.

People living with diabetes are faced with a number of associated health problems, including foot infections, urinary tract infections, and surgical site infections.

The former in particular can have serious consequences when left untreated: Diabetic foot infections (DFIs) remain the most common cause of nontraumatic foot amputations among people living with diabetes – 15% of patients experience this.

The infections are mostly found at the bottom of the foot, within its soft tissue, and they are often caused by more than one pathogen – with between 50% and 80% of these wounds being polymicrobial. The pathogens often responsible for DFI infections include S. aureus, Enterococcus, P. aeruginosa, and E. coli.

Taken together, the seriousness of diabetes growth within Indonesia – plus the large percentage of people who experience foot amputations as a result of DFIs – makes Recce’s Registrational Phase 3 trial for its topical gel to treat the latter a timely study.

In fact, it is one of the largest DFI studies in the world, and the first of its kind within Indonesia.

This was acknowledged by the chairman of Indonesia’s Drug and Food Regulatory Authority – also known as Badan POM – who said:

“The approval of Recce Pharmaceuticals’ Phase 3 clinical trial is an important step in advancing treatment options for DFIs in Indonesia. Badan POM is committed to supporting the timely development of innovative therapies to address this critical health challenge. This collaboration aligns with Indonesia’s mission to advance healthcare solutions for our population, and we look forward to seeing the impact of this trial for patients in need of new, effective anti-infective treatments.”

While contributing to Indonesia’s healthcare landscape through the introduction of a novel treatment for infectious diseases is a key goal of this trial, it also aligns with Recce’s goal of pushing its topic gel through to commercialisation.

Recce’s chief executive officer James Graham said being able to move forward with the Phase 3 trial was an important milestone for the company.

“The approval from the Indonesian National Drug and Food Authority to initiate this pivotal Phase 3 trial in Recce’s clinical development is a significant achievement, bringing Recce closer to commercialisation and profitability,” he said.

“We also acknowledge the support of Investment NSW, Austrade, and the Australian Embassy team in Jakarta who played an important role in helping with the approval process.

“We look forward to evaluating R327G in our first Phase 3 trial.”

As an anti-infective, the company’s R327 candidate is being assessed in various forms to check its efficacy in treating various bacterial wounds, burns, and skin infections.

During a preclinical study on rats, it revealed notable antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections.

In the form of a topical spray, R327 is also the subject of an ongoing Phase I/II study in patients with infected burn wounds, and has demonstrated impressive data so far, including the return of healthy skin growth, reduced swelling and infection, and signs of tissue penetration to the underlying infection.

Building on the success of this trial, Recce commenced a Phase I/II proof-of-concept study at the South West Sydney Limb Preservation and Wound Research Unit to evaluate the safety and efficacy of R327 in patients with mild skin and soft tissue diabetic foot infections (DFIs).

Thus, Recce’s new trial initiative in Indonesia aims to build on a solid history of assessment for this treatment.

Recce has been trading at 47 cents.

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These results were based on preclinical studies of AI-168, whose composition was also refined as a result, with Algorae filing an International Patent Cooperation Treaty (PCT) application, enabling it to pursue patent protection for the drug candidate in commercially significant jurisdictions.

The preclinical tests were undertaken at Monash University Victorian Heart Institute Research Laboratories. They sought to assess the formulation of AI-168 and compare its performance with beta blockers using well-established in vitro models of cardiovascular disease.

AI-168 is a combination drug candidate comprised of a cardio selective beta blocker with cannabidiol.

In terms of intellectual property strategy, Algorae announced the filing of an initial patent application on November 23, with the more recent PCT patent application including data received after that point through the preclinical work. The latter application is an important one for international patent protection for AI-168.

Algorae shares moved up on the news, and at 13:24 AEDT, they were trading at 0.8 cents – a rise of 14.29% since the market opened.

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