Latest news with #Argenica
News.com.au
5 days ago
- Business
- News.com.au
Morgans spotlights nine healthcare stocks with upcoming catalysts after 'upbeat' Bioshares Biotech Summit
Morgans' Scott Power describes mood at Bioshares Biotech Summit as "markedly more upbeat than prior years" with signs of a rotation back to ASX healthcare sector Power highlights nine ASX healthcare companies from summit with clear near-term catalysts over next three to six months Results from Argenica's phase II trial of lead product ARG-007 in acute ischaemic stroke patients expected in early September In a further positive sign the ASX healthcare sector may be recovering, Morgans' senior healthcare analyst Scott Power has returned from the 19th annual Bioshares Biotech Summit, describing the mood of presenting companies as "markedly more upbeat than prior years". The summit, which featured presentations from more than 30 biotech companies, followed a strong July for the healthcare sector, which rose 9.05% to be best performer of the 11 ASX sectors. While healthcare remains the worst-performing sector YTD, up just 1.81%, the solid July results and positive momentum at this year's Bioshares conference signals a positive turnaround. Attended by analysts along with institutional and high net worth investors, Stockhead's Tim Boreham refers to the summit as the "Druggies & Dealers' conference – a playful nod to the well-known annual Diggers & Dealers mining forum, which this year fell in the same week. "The conference was centred on the evolution and strategic positioning of Australian biotech companies across the drug development lifecycle, with a strong emphasis on innovation and commercialisation," Power said. "We generally got the sense there is a lot more happening in the background for many of these companies than first glance." Power has highlighted nine ASX healthcare companies presenting at the summit with clear near-term catalysts over the next three to six months. Morgans nine ASX healthcare stocks with upcoming catalysts Neuren Pharmaceuticals (ASX:NEU) Market cap: $2.2 billion Neuren develops drugs for the treatment of neurological disorders and became the darling of the ASX biotech sector in 2023 when trofinetide, marketed as DAYBUE, received US Food and Drug Administration approval as the first and only approved treatment for Rett syndrome – a rare neurological disorder mostly affecting girls and emerging in infancy. Acadia Pharmaceuticals, Neuren's partner, markets DAYBUE in North America with the Aussie biotech eligible to receive double-digit royalties payments. Power said the key upcoming catalyst for Neuren would be an expectation of continued improvement in DAYBUE net sales in Q3 CY25. The company's latest quarterly sales were US$96.1 million, up 14% on pcp. CogState (ASX:CGS) Market cap: $295.9 million Cogstate is a neuroscience technology company focused on optimising neurological health assessments to advance the development of new medicines and deliver clinical insights into brain function. Its Cognigram digital cognitive assessment system is used by physicians to monitor key aspects of neurological performance, including processing speed, attention, visual learning, working memory and executive function. CogState has provided FY25 guidance of revenue between US$52 to US$54 million, up 20% to 24% and profit before tax between US$12 to US$14 million. "CGS will report its FY25 result on August 22 with the existing share buyback expected to be extended," Power said. Market cap: $95m The key upcoming catalyst for Argenica is results forecast for early September of a phase II trial of its lead product ARG-007 in acute ischaemic stroke patients. ARG-007 is a synthetic peptide designed to protect brain cells from dying in the critical minutes and hours after acute neurological events such as stroke, traumatic brain injury (TBI) and hypoxic brain damage. In April, Argenica completed dosing of 92 patients in the double-blinded, randomised, placebo controlled phase II trial undertaken at eight emergency departments around Australia. Data-read out from the trial is due in September with safety the main endpoint, determining if the drug asset can advance further in clinical development. Blinklab (ASX:BB1) Market cap:$55m Blinklab is a company founded by neuroscientists at Princeton University and has developed a smartphone based diagnostic platform for autism, ADHD, schizophrenia and other neurodevelopmental conditions. "The key short term catalyst is the release of results for BB1's pilot study for autism involving around 190 children," Power said, "The study undertaken at two sites is on track to finish recruitment in August with data locking and unblinding to follow and results expected to be released in September. "A main phase trial is expected to follow recruiting up to 900 children across eight additional sites." Clever Culture Systems (ASX:CC5) Market capitalisation $62.4 million Adelaide-based Clever Culture Systems has developed the only US FDA-cleared AI technology for automated culture plate reading. Its APAS (automated plate assessment system) Independence instruments automatically analyse culture plates to detect microbial contamination, classifying growth as significant or non-significant. In sterile drug manufacturing, culture plates are used inside cleanrooms to monitor for contamination, with results critical to releasing safe and effective drugs. Clever Culture's APAS Independence reduces the time consuming manual analysing of the culture plates by microbiologists. "CC5 has signed up three large pharmaceutical companies including AstraZeneca, Bristol Myers Squibb and Novo Nordisk plus two large lab companies and is in negotiations with other tier one groups," Power said. "Announcements around additional customers or expansion with existing customers is a key short-term catalyst." Tetratherix (ASX:TTX) Market cap: $215 million Wound management house Tetratherix made its ASX debut on June 30, breaking an IPO drought for the sector. Barrenjoey Markets and Morgans Financial were joint lead managers and underwriters to the Tetratherix IPO. Tetratherix has developed a proprietary polymer platform enabling the targeted delivery of cells, drugs and biologics, to treat a range of conditions across tissue spacing, bone regenerative and tissue healing. The company will post its maiden FY25 result in late August. "The near-term catalysts we expect to be called out include progress on the bone regeneration franchise which is targeting FDA clearance in H2 CY26 and an update on the recruitment in the trial for Cohort 2 using TetraDerm (tissue healing) involving surgical incisions in the face and neck," Power said. Micro-X (ASX:MX1) Market cap: $52 million Micro-X has proprietary cold cathode, carbon nanotube (CNT) emitter technology which is focused on medical imaging and security applications. The company recently announced a significant commercial milestone, a three-year supply agreement with a major US healthcare provider for its Rover Plus mobile radiology system. The deal followed a successful evaluation and competitive tender by the healthcare provider, which operates more than 700 facilities nationwide. It has added Rover Plus to its approved procurement list, allowing member hospitals to purchase the system without further evaluation or tendering. "We expect additional supply agreements will be executed over the near-term," Power said. Dimerix (ASX:DXB) Market cap: $300m Dimerix's lead drug candidate DMX-200 is in a phase III trial for Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease. The ACTION3 phase III trial continues to recruit across clinical sites globally, with more than 190 sites activated. Full targeted recruitment of 286 patients for the ACTION3 trial is expected to be completed by the end of CY25. Dimerix is also developing DMX-700 for respiratory disease. "Following a positive interim analysis (Part 1) another interim analysis (Part 2) is expected to be released late CY25 or early CY26," Power said. Artrya (ASX:AYA) Market cap: $148m Artrya is developing AI-powered solutions to improve the detection and management of coronary artery disease. Its proprietary software called Salix analyses coronary CT scans to identify key biomarkers of heart disease, supporting clinicians in diagnosing patients more accurately and efficiently. Artrya has three key modules in its Salix platform. The FDA-cleared and launched Coronary Anatomy module is already in market. Power said upcoming catalysts for the company included FDA clearances of its Coronary Plaque module, expected in Q3 CY25, and its Coronary Flow module, anticipated in Q1 CY26. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
News.com.au
10-08-2025
- Health
- News.com.au
Clock ticking as Argenica nears phase II stroke trial readout
Argenica's phase II trial results of lead drug ARG-007 in acute ischaemic stroke patients forecast for early September Trial completed in April with safety main endpoint and earlier studies showing promise in protecting brain cells Argenica's ARG-007 would be the first neuroprotective drug on the global market if approved The countdown is on for investors in Perth-based Argenica Therapeutics (ASX:AGN) with results forecast for September of a phase II trial of its lead product, a neuroprotective treatment known as ARG-007 in acute ischaemic stroke patients. Argenica's ARG-007 is a synthetic peptide designed to protect brain cells from dying in the critical minutes and hours after acute neurological events such as stroke, traumatic brain injury (TBI), and hypoxic brain damage. When it comes to acute neurological events, 'time is brain' — with around 1.9 million brain cells dying every minute that blood flow is halted. But ARG-007 is showing promising signs of preventing such catastrophic damage by protecting brain tissue during and after these critical neurological events. Initial target most common form of stroke CEO and managing director Dr Liz Dallimore, who has previously worked as a research scientist in neuroscience, has headed Argenica since its ASX-listing in 2021. Dallimore said acute ischaemic stroke was the most common type of stroke, caused by a blockage in a blood vessel in the brain. "Acute ischaemic strokes make up around 85% of strokes with the other type haemorrhagic, which is a bleed on the brain," she explained. "They present the same with the only way to differentiate by medical imaging. "A major reason we're targeting acute ischaemic stroke is many of these patients have a thrombectomy, where a radiologist inserts a catheter through the wrist or groin and guides it up into the brain to physically remove the clot." However, a thrombectomy has risk of reperfusion injury, which occurs when blood flow rapidly returns to previously oxygen-deprived brain tissue after a clot is removed and potentially causes additional damage. "ARG-007 has a second chance to work by protecting the brain against this secondary injury which can occur through the procedure," Dallimore said. Phase II in acute ischaemic stroke complete Argenica completed dosing of patients in a double-blinded, randomised, placebo controlled phase II trial of ARG-007 in acute ischaemic stroke patients in April. Involving 92 patients presenting to eight emergency departments around Australia, data-read out from the trial is due in September with safety the main endpoint, determining if the drug asset can advance further in clinical development. "Safety in a neurology trial is really important because you have to show your drug does no harm," Dallimore said. "It's quite different to an oncology drug where you can have some toxicity because you're trying to kill a cancer. "In this case we must ensure we're doing no harm to the brain or patient and safety is the main aspect big pharma and regulators will look at for ARG-007. Throughout the trial Argenica has had a data safety monitoring board reviewing all the data and making sure there's nothing unusual in terms of a safety profile. The secondary endpoint for the trial will examine efficacy, with a brain scan taken 48-hours post administration of either the placebo or ARG-007. "We are comparing the placebo group to treatment group to see whether our drug has reduced that brain injury," Dallimore said. "By administering our drug prior to the thrombectomy, we believe it has the potential to limit the progression of brain injury following thrombectomy, whereas in the placebo group, that damage may continue to expand." Promising preclinical results drive Argenica's push into human trials A spinout from the University of Western Australia and Perth-based Perron Institute for Neurological and Translational Science, ARG-007 has shown early success, including in preclinical studies and a phase I trial. Dallimore said what provided researchers confidence to progress into clinical trials was a non-human primate study that closely reflected how acute ischaemic stroke was treated in hospitals. "The drug was administered ahead of a standard thrombectomy procedure, simulating the real-world treatment pathway," she said. "That study was done out of Canada and showed a 70% reduction in brain injury." Dallimore said the study convinced researchers to take the drug forward into clinic trials and list Argenica on the ASX. First-of-kind 'holy grail' therapy targeting high need ARG-007 would be the first neuroprotective drug on the global market if approved, tapping into a large addressable global market for stroke and potentially other indications. The global stroke management market was valued at $36.1 billion in 2022, and is projected to reach $74 bn by 2032, driven by several factors including a growing ageing population. There are more than 45,000 strokes annually in Australia and 795,000 in the US – the world's largest healthcare markets. The estimated cost of stroke to the healthcare system in the US is forecast to reach ~US$184.13 bn by 2030. "There are no neuroprotective drugs on the market and neuroprotection really is the holy grail just because you get almost two million brain cells dying every minute,' Dallimore said. "Ultimately, we want this drug to be in every ambulance so as soon as a paramedic arrives and suspects a stroke they administer our drug." She said a lysis drug, also known as a thrombolytic, is often given to dissolve blood clots in ischaemic stroke. However, a lysis drug must not be given to patients with haemorrhagic stroke as it can significantly worsen bleeding in the brain. "ARG-007 will not exacerbate bleeding, and we haven't really looked at whether its efficacious in haemorrhagic stroke but suspect it probably will be but the main aspect for paramedics is doing no harm to the patient," she said. She said success in acute ischaemic stroke opens the doors for use of ARG-007 in other indications. "Ultimately, it could be given to anyone suspected of having some sort of brain injury whether from stroke, cardiac arrest with blood flow restriction to the brain or an accident," she said. "Essentially, what it does is hibernates those brain cells and stops them dying – buying that patient time to get to the hospital and treatment." Lining up against few competitors Dallimore said its closest competitors were in phase II trials with one Spanish company targeting inflammation, which has done a deal with big pharma Merck KGaA who will run its later stage trials. "The mechanism is very different to ARG-007 with our drug working in the acute phase trying to block the calcium flowing into the brain cells causing the injury," she said. "So, their drug is working to treat the inflammation which can also exacerbate brain injury." Dallimore said another global company was also in a phase II trial and while its approach was mechanically like ARG-007 extensive comparative work had demonstrated more promising efficacy for Argenica's treatment. "If we can hit that primary endpoint in the trial it should be a big value inflection and icing on the cake would be to show efficacy as well," she said. Looking to partner for future trials Argenica is planning its later stage clinical program for ARG-007 working with the US Food and Drug Administration (FDA) to get approval for future studies in the US, along with regulators in Europe and China, where stroke is now the leading cause of death. "Ideally, we could do some type of deal with a bigger pharma company with an interest in stroke or neurology when we get the Phase II results," Dallimore said. "Typically, that might look like they would give us an upfront payment to help fund the trial and then milestone payments along the way."
News.com.au
10-06-2025
- Health
- News.com.au
Health Check: RFK delivers knockout jab to powerful US vaccines committee
US health secretary sacks 17-member panel that advises on US vaccine policy, to 're-establish public confidence in vaccine science' FDA delivers Argenica a stroke trial knock-back, but Syntara is in the fast lane EZZ Life Science soars up to 29% on Southeast Asia distribution deal In a move dubbed both dramatic and extraordinary, US Health Secretary Robert F. Kennedy Jr has sacked all 17 members of a body that determines vaccine dosages and at what age they should be administered. In dehiring the Centers for Disease Control's advisory committee on immunisation practices, RFK said: 'a clean sweep is needed to re-establish public confidence in vaccine science'. Given the famed Kennedy family scion is an anti vaxxer (though he claimed otherwise at his confirmation), some may see the action through a different lens. RFK notes the 'rubber stamping' committee has never recommended against a vaccine – 'even those later withdrawn for safety reasons'. He cites the committee's 'perceived conflicts of interest' and eroded public trust in vaccines, health agencies and pharmaceutical companies. 'Some would try to explain this away by blaming misinformation or anti-science attitudes,' he writes. 'To do so, however, ignores a history of conflicts of interest, persecution of dissidents, a lack of curiosity and skewed science that has plagued the vaccine regulatory apparatus for decades.' Ouch! A central role According to Endpoints News, for four years the panel has played a central role in advising the government on public health policy. During its swansong meeting at the end of the month, the committee is likely to mull recommendations for Covid vaccines. 'RFK had already begun to undercut the committee's work after he unilaterally changed the Covid vaccine schedule to remove recommendations for pregnant women and to change the guidance for children,' Endpoints says. The newsletter says the US Food & Drug Administration (FDA) is expected to approve Covid jabs only for older and at-risk Americans. The sackings come amid a sharp decline in US vaccination rates well before the Trump Administration took office in January. According to Johns Hopkins University research, childhood vaccination rates for measles, mumps and rubella have been declining since the start of the pandemic. Data from 2066 counties in 33 states shows an average decrease from almost 94% before the pandemic to about 91% after the pandemic, well below 'herd immunity' levels of 95%. Keep an eye on CSL and Medadvisor In an Australian context, stocks vulnerable to any official anti-vaxx measures are CSL (ASX:CSL) and MedAdvisor (ASX:MDR). While CSL derives the lion's share of revenue from blood plasma products, its Seqirus arm is exposed to US flu vaccine demand. Seqirus' December half revenue fell 9%, with 'low immunisation rates significantly impacting the US flu market.' The company believes the problem should right itself when the consequences of a bad flu season – such as increased hospitalisations – become apparent. Medadvisor runs medication compliance programs for Big Pharma, with vaccines accounting for 30 to 50% of its US revenue (depending on the season). Medadvisor's half-year results were impacted by two big pharmaceutical customers reducing their vaccine promotional budgets. Medadvisor chief Rick Ratliff suggests the 'vaccine fatigue and hesitancy' has been compounded by the number of new vaccines to hit the market. These include prophylactics for shingles, RSV (respiratory syncytial virus) and pneumococcal vaccines. FDA strikes down stroke trial Stroke drug developer Argenica Therapeutics (ASX:AGN) appears to have fallen victim to the FDA's staffing turmoil, with the agency slapping a 'clinical hold' on the company's Investigational New Drug (IND) application. An IND is permission to start a trial; a 'clinical hold' means the applicant needs to do more homework. The agency declared the company's non-clinical data to support the IND 'is not adequate to support initiation of a proposed acute ischaemic stroke trial in the US at this time'. Argenica said it had expected 'some challenges' in receiving the go-ahead within the stipulated 30 days, 'due to current resourcing challenges at the FDA'. As a result, it submitted the application 'much earlier than required'. The company protests – mildly – that it had fulfilled the FDA's requirements, as outlined at a so-called type B meeting. 'Whilst we are obviously disappointed ... we are confident we can provide the additional data required by the FDA in a timely manner,' says Argenica CEO Liz Dallimore. The FDA decision does not affect Argenica's separate phase II trial being carried out here. The study is due for a readout in the September quarter. Meanwhile, the agency has granted advanced stage myelofibrosis developer Syntara (ASX:SNT) fast track designation for its drug candidate SNT-5505. As its name implies, fast track status enables more frequent FDA interaction and discussions on accelerated approval. Syntara says the FDA's stance recognises the significant unmet medical need in myelofibrosis, a rare and serious blood cancer. EZZ inks distribution deal EZZ Life Science (ASX:EZZ) is expanding its Asian foothold by signing up a distributor for Thailand, Vietnam and Singapore for its EZZ-branded products. The three-year deal with ROFA Enterprises Pty Ltd entails minimum purchases of $21 million over the contract term, with ROFA managing all local marketing, logistics and distribution costs. "This is a major milestone in our regional expansion strategy,' EZZ chair Glenn Cross says. 'ROFA's established presence and deep experience in Southeast Asia make them an ideal partner to help scale EZZ's brand footprint across these important markets.' Over the last decade, ROFA Enterprises has exported Australian and NZ dairy, health and beauty products to Southeast Asia. ROFA's distribution network includes more than 10,000 pharmacies, mother and baby stores, supermarkets, and online platforms. Based on genomic life sciences, EZZ has dozens of products on its books. Its bestsellers are lysine (amino acid) growth capsules, bone growth chews and the EZZ Smart Clarity Booster (for enhanced brain function). Investors applauded the deal, with EZZ shares soaring up to 29%. Study highlights Avita's burns treatment credentials Wounds management house Avita Medical (ASX:AVH) says a study of its flagship Recell shows the spray-on skin treatment has reduced hospitalisations by 36%. Avita cites US data aired at the British Burn Association's (BBA) annual meeting, which analysed more than 6300 patients treated with Recell between 2019 and 2024. These patients had total body surface area wounds of less than 30%. Compared with grafts, these patients had an average 35.7% reduction in hospital time, or 6.2 days. The company cites cost savings of $300 million over the 5-year study period. As with grafts, Recell uses the patient's own skin to treat the wound. The difference is the treatment requires only a small amount of material. 'Reducing hospital length of stay has a direct impact on the cost of care, especially in complex cases like severe burns,' Avita CEO Jim Corbett says. More than US 130 burn centres use Recell, but the company is seeking to expand into larger applications such as full-thickness skin defects.
