Latest news with #Dimerix
News.com.au
01-07-2025
- Business
- News.com.au
Biocurious: Dimerix could be riding big and beautiful kidney drug success earlier than expected
With the FDA's blessing, Dimerix will use phase III trial endpoints that could lead to accelerated approval for its kidney disease drug Dimerix is confident of phase III success because an expert 'peek' at the blinded data shows it's on the right track The company is well cashed up, courtesy of four global distribution deals When it comes to clinical trials, the choice of primary endpoints can mean the difference between a trial failing and a billion-dollar blockbuster drug emerging. Plenty of drug candidates have looked successful at mid stage, but then floundered because a later stage trial has failed to meet strictly defined goals. This appears to be the case with Opthea (ASX:OPT) and the recent failure of its two phase III eye disease trials. In other cases, strictly enforced endpoints mean that a trial is too long and too expensive. But regulatory attitudes are changing. In the case of Dimerix (ASX:DXB), the US Food & Drug Administration (FDA) has delivered the kidney disease drug developer a concession on endpoints for its ongoing phase III trial. The FDA's stance not only means that the endpoints are more likely to be achieved, reducing risk. It also means the company could win accelerated FDA marketing approval before the study has completed. 'That sparked a lot of interest in the sector because suddenly the trials are more manageable,' says Dimerix chief Dr Nina Webster. The 286-patient study is testing Dimerix's candidate DMX-200 for the regressive focal segmental glomerulosclerosis (FSGS). A rare – but not ultra rare – disease, FSGS usually results in end-stage kidney failure. Endpoints have delayed the endgame Previously, the FDA had set an endpoint of how well a drug preserves kidney function. But this meant a trial had to track the patient to kidney failure or death, which could take years. This makes a trial too long and too costly. 'In rare diseases, no-one is going to do these studies,' Webster says. About five years ago the FDA became more amenable to the use of 'surrogate' endpoints These are measures that substitute a true clinical endpoint to expedite drug development. The FDA allowed the use of the kidney function biomarker, called estimated global filtration rate (eGFR). Under the dainty banner of 'Parasol' – and, no it's not an umbrella group – experts advised the use of proteinuria as a further alternative endpoint for FSGS. Proteinuria is kidney proteins seeping into the urine, while eGFR is the rate at which the spuds can cleanse blood. If proteinuria is present and the eGFR is not up to scratch, they are sure signs the kidneys are not working as they should. Conversely, if a drug reduces proteinuria or the eGFR 'slope rate' – the rate of decline – it is accepted as being effective. Parasol promises faster Action Dubbed Action 3, the Dimerix trial involves two years' treatment, as measured against placebo. The study is due to complete in 2027 when the last patients have been treated. But Dimerix now is working with Parasol to establish the exact surrogate endpoints required to front the FDA for accelerated marketing approval. Expedited approval is as allowed for some orphan drugs, such as DMX-200. 'The full study is for two years and that doesn't change,' Webster says. 'Th question is whether we can get interim approval and go to market earlier.' One possibility is that proteinuria alone could be the accepted endpoint, given proteinuria and eGFR appear to point to the same thing. That is: deteriorating kidneys. Dr Webster says an accelerated endpoint must reasonably predict the outcome of the trial. 'The question is, what do we need to see at point X to prove the end at point Y? Parasol is working with us on that. 'We're collecting all of our data on eGFR and proteinuria anyway, so it gives us a lot of flexibility in the program.' (Other geographies such as Japan and Europe still require an eGFR endpoint). Surrogate change spurs others … The FDA's stance on surrogate endpoints could be a double-edged sword for Dimerix, as it also provides succour to potential rivals. In this vein, a drug called sparsentan (brand name Filspari ) won FDA approval for a kidney condition called IgA nephropathy. The drug failed its Phase III endpoint for eGFR. But now its owner Travere Therapeutics is having a crack at FDA marketing approval for FSGS using a proteinuria endpoint. The data from the supportive trial was unblinded, which means the study custodians can't change the endpoints retrospectively. 'But the FDA is in a hard spot with this one because is an area of such high unmet need,' Webster says. 'These patients currently have limited treatment options and Filspari looks like it is doing something for them. 'We are waiting with bated breath in the hope that Filspari is approved and gives hope to these patients.' Travere has licensed the European and local sparsentan rights to our own CSL (ASX:CSL). … but we're friends, not rivals Webster says rather than rivalling DMX-200, sparsentan could be used in unison. An angiotensin receptor, sparsentan targets high blood pressure – a key cause of kidney disease in the first place. (High blood pressure causes inflammation which causes scarring and cell death). Thus, sparsentan needs to be better than the current blood pressure medication. But DMX-200 works on the secondary inflammatory pathway, with the patients already on blood pressure meds. 'It's not apples for apples with study design, which is why we are compared against the placebo and not a comparator,' Webster says. In effect, DMX-200 faces a lower comparative hurdle. 'Our drug is complementary, not competitive,' Webster says. Data 'peek' hints at trial success While a trial result is never certain, Dimerix is confident it won't meet the fate of Opthea or Percheron Therapeutics (ASX:PER). (The latter's neurological disease trial also failed to meet primary endpoints). One reason is that the Action 3 trial already has been subject to a blinded interim analysis by an arm's length expert committee, which peeked at the data. 'Blinded' means that Dimerix, the trial investigators and the patients don't know the results. In March last year the 72-patient analysis reported that DMX-200 worked better than placebo. As per protocol, the experts did not disclose the extent of this efficacy. But it was enough for the company to know that it's on the right track. 'We just know at that point in time, we were doing better and that if we carry on that trajectory, we have a shot at the endpoint,' Webster says. 'That was a big moment for us, because we wanted to confirm something similar to our smaller phase II study in a larger cohort of patients.' FDA approval could come sooner rather than later Dimerix has received over $65 million of cash, courtesy of four distribution deals that may deliver up to $1.4 billion of milestone payments plus royalties. While a further capital raising is a case of 'never say never', it's unlikely. Naturally, most of the milestones are back ended to achievements such as phase III success and FDA approval. But with accelerated approval possible after the interim analysis, the latter might be sooner than investors think. Many drug developers view the Trump Ascendancy Mark Two with trepidation. In contrast, Webster notes Trump nominated kidney disease as a key health priority in his first stab at POTUS. The financial motive alone is compelling, in that dialysis costs the US health system around US$125 billion annually. 'We are in the sweet spot of being a rare disease (with pricing benefits) and having the potential to reduce US healthcare costs,' Webster says.
News.com.au
30-06-2025
- Business
- News.com.au
Health Check: Tetratherix breaks biotech IPO drought with 13pc gain on debut
Tetratherix's listed life starts on a solid note Dimerix pockets a $4.2 million milestone – with close to $1.4 billion to come Orthocell chalks up first commercial US procedure for its Remplir device Today's ASX debut of wound management house Tetratherix (TTX) has raised the hopes of other life-science plays that have eyed an IPO but have relegated the idea to the too-hard basket. Having downsized its offer from $35 million $25 million to banish the fast money, Tetratherix traded up to 13% above their $2.88 a share offer price. The company has developed an injected liquid polymer that hardens at body temperature and then biodegrades after the job is done. Yet to be approved, the platform-based tech targets novel applications including tissue healing, bone regeneration and surgical spacing (such as in prostate radiation therapy). CEO Will Knox dubs the platform as 'medical Lego', in that the products are built from the same polymer structure. 'That means you can use the same underlying biological performance and safety data in all regulatory applications. 'Our path to market is a lot faster and simpler because the data is interchangeable across the different applications.' Post raising, Tetratherix has cash of circa $30 million. This factors in two US Food & Drug Administration (FDA) approval applications, one further submission and 'multiple clinical trial readouts'. Tetratherix is the first life sciences IPO since late November 2024, when cryogenics play Vitrafy Life Sciences (ASX:VFY) and nerve repair house ReNerve (ASX:RNV) listed on the same day. Their shares are down 20% and 50% to date, respectively. Aptium is on IPO foot-ing The developer of an AI-powered tool for the podiatry market, the private Aptium is eyeing an IPO after a private whip-'round. Aptium's scanner provides real-time thermal and three and four dimensional analysis of motion and the shape of the foot. This enables 3D manufacturing of patient-specific insoles 'with precision-grade firmness and softness:. The tech also may detect diabetic foot ulcers early. Co-founded by biotech greybeards Dr Mel Bridges and Carl Stubbings, Aptium is seeking to tap $5 million in a private convertible note round. The company aspires to list within the next 18 months or so. Bridges has founded six companies, including ImpediMed (ASX:IPD) and the formerly ASX-listed Panbio. Stubbings was former CEO of Sienna Cancer Diagnostics, which merged with Bard1 to become Inoviq (ASX:IIQ). Aptium could test IPO appetite in more ways than one. That's because the company is 40% owned by Greg Creed, the former CEO of US giant Yum! Brands which owns KFC, Pizza Hut and Taco Bell. Dimerix pockets first milestone from Japanese partner Kidney drug developer Dimerix (ASX:DXB) has pocketed $4.2 million as its first milestone payment from Japan's Fuso, one of the company's four global partners. Signed in January this year, the Fuso compact could deliver up to $100 million of milestone payments. This is subject to progress on Dimerix's lead phase III program, for the kidney ailment focal segmental glomerulosclerosis. In October 2023 Dimerix inked distribution deals with the London-based Advanz Pharma (covering Europe, Canada, Australia and New Zealand). The company followed up in May last year by entering a Middle East licensing agreement with the Oman-based pharma group, Taiba. In its biggest deal, Dimerix last May signed up the Nasdaq-listed rare diseases house Amicus Therapeutics for the US honours. Collectively, the deals promise $1.4 billion of potential milestones, largely contingent on eventual FDA drug approval. The Amicus deal alone involves of US$520 million of success-based payments. The Fuso milestone became payable on opening of the first Japanese site for the Action 3 trial. Investors now expect likely follow-on deals in territories including China, Latin America and South Korea. LTR Pharma is full bottle on safety study Drug development is all about getting the small stuff right, such as whether the packaging is tickety-boo. In this vein, LTR Pharma (ASX:LTP) has affirmed that the bottle and pump components for its proposed nasal mist based erectile dysfunctional treatment meet accepted standards. LTR completed the so-called extractables study with co-development partner Aptar Pharma. The study confirmed that all detected compounds met International Council for Harmonisation safety thresholds – the standard adopted by the FDA and other agencies. A 'leachables' study is now underway, to support an FDA marketing submission. As the name suggests, the leachables study evaluates the potential migration of compounds from packaging into the liquid. This takes account of 'real-world' storage conditions, such as the back of the bedside drawer. The study will run for at least 24 months, after which the company can submit its FDA entreaty. Dubbed Spontan, LTR's treatment is based on the same active ingredient as current oral treatments but is much faster acting. LTR is also developing Oroflow, a spray treatment for a group of ailments that affect swallowing function. Orthocell hits the right nerve Nerve repair play Orthocell (ASX:OCC) reports the first use of its Remplir device in a US surgical procedure, to repair a foot injury. The FDA approved Remplir in April. The company says the first use is a crucial step in its US rollout, 'building surgical experience and knowledge of the product that will be key in driving product sales'. Remplir is a collagen 'wrap' that improves regeneration of damaged nerves and requires less stitching. The surgery took place at an unnamed Ohio hospital, sourced from Orthocell's network of 14 specialist distributors. These intermediaries have 'mature, direct-to-surgeon, hospital and other customer relationships' across 25 US states. Orthocell CEO Paul Anderson said the critical first step in the US rollout was 'getting Remplir into surgeons' hands for them to gain familiarity with its key features and benefits in clinical practice'. The company promises 'material' sales growth in the December half - which of course starts tomorrow – with the financial benefits reflected in the June half 2026 accounts. Orthocell estimates that surgeons carry out two million peripheral nerve repairs annually, equating to a US$3.5 billion market. This is across its approved markets of Australia/New Zealand, Singapore, the US, Europe/UK, Canada, Brazil, Japan, Hong Kong and Thailand.
News.com.au
20-06-2025
- Business
- News.com.au
Closing Bell: ASX arrests slide to fall just 0.2pc as utilities sector leads recovery
ASX pulls back from 0.55pc slide to dip 0.21pc Utilities leads recovery, up 0.74pc ASX All Ord Gold index climbs 0.62pc ASX pulls out of tailspin to make up ground While the ASX closed lower today, down 0.21%, it was looking a lot worse around lunchtime, when the bourse was 0.55% in the red. The market managed to put the breaks on its slide, with the utilities (+0.74%) sector in particular providing support, followed by industrials, health care and info tech. Standouts in those sectors included Dimerix (ASX:DXB) up 9.8%, ZIP Co (ASX:ZIP) adding 5.9%, Droneshields (ASX:DRO) up 5.6% and Fluence Corporation (ASX:FLC) jumping 13.8%. The ASX All Ord Gold index (+0.62%) also put in some work, alongside the Small Ords (+0.19%). The ASX lost 0.49% over the last five trading days, now sitting 1.55% off its 52-week high. ASX SMALL CAP LEADERS Today's best performing small cap stocks: Security Name Last % Change Volume Market Cap PV1 Provaris Energy Ltd 0.015 50% 3831208 $6,980,013 E79 E79Goldmineslimited 0.028 40% 2009033 $3,168,253 MOH Moho Resources 0.004 33% 5000 $2,236,242 RNX Renegade Exploration 0.004 33% 521227 $3,865,090 HAW Hawthorn Resources 0.068 28% 634353 $17,755,827 BMO Bastion Minerals 0.002 27% 22379119 $1,419,960 NSB Neuroscientific 0.078 26% 991242 $8,965,502 ALM Alma Metals Ltd 0.005 25% 807408 $6,345,381 AUK Aumake Limited 0.0025 25% 176755 $6,046,718 CUL Cullen Resources 0.005 25% 183700 $2,773,607 FIN FIN Resources Ltd 0.005 25% 100000 $2,779,554 GGE Grand Gulf Energy 0.0025 25% 1458526 $5,640,850 JAV Javelin Minerals Ltd 0.0025 25% 651325 $12,252,298 MEM Memphasys Ltd 0.005 25% 1004099 $7,934,392 HCL Highcom Ltd 0.295 23% 641196 $24,643,841 HAR Harangaresources 0.065 20% 4915026 $11,585,428 MCA Murray Cod Aust Ltd 1.045 20% 124393 $92,023,850 AJL AJ Lucas Group 0.006 20% 356600 $6,878,648 TON Triton Min Ltd 0.006 20% 2099975 $7,841,944 HIQ Hitiq Limited 0.02 18% 3191499 $6,885,382 BAS Bass Oil Ltd 0.027 17% 2429874 $7,345,899 AHN Athena Resources 0.007 17% 6103136 $13,595,742 BGE Bridgesaaslimited 0.014 17% 61111 $2,398,310 NAE New Age Exploration 0.0035 17% 50877 $8,117,734 PGY Pilot Energy Ltd 0.007 17% 4218242 $12,951,960 Making news… Hydrogen compression and shipping solution company Provaris Energy (ASX:PV1) has teamed up with global shipping leader 'K' LINE. K LINE, otherwise known as Kawasaki Kisen Kaisha, will provide technical, commercial and operation support, offering its extensive global shipping expertise as PV1 develops its hydrogen transport and storage model. PV1's main focus is the proprietary H2Neo Carrier and H2Leo Barge, which offer a combination of offshore compression, storage and shipping solutions for hydrogen gas transportation. Bastion Minerals (ASX:BMO) has tapped John Ribbons as company secretary, effective immediately. The appointment follows the resignation of Justin Clyne, who exits on good terms with the board and will make himself available during the transition. Ribbons will fill dual roles, as he already holds the position of chief financial officer for BMO as well. ASX SMALL CAP LAGGARDS Today's worst performing small cap stocks: Security Name Last % Change Volume Market Cap RPG Raptis Group Limited 0.044 -73% 2637660 $56,109,577 CT1 Constellation Tech 0.001 -50% 1542725 $2,949,467 BCB Bowen Coal Limited 0.18 -49% 2933425 $37,715,145 BEL Bentley Capital Ltd 0.008 -33% 7852 $913,535 ENT Enterprise Metals 0.002 -33% 2756 $3,543,952 FTC Fintech Chain Ltd 0.002 -33% 530785 $1,952,309 PKO Peako Limited 0.002 -33% 2925298 $4,463,226 RLC Reedy Lagoon Corp. 0.001 -33% 135000 $1,165,060 SHP South Harz Potash 0.002 -33% 310000 $3,308,186 ADD Adavale Resource Ltd 0.0015 -25% 186313 $4,574,558 AFA ASF Group Limited 0.003 -25% 79842 $3,169,590 ASR Asra Minerals Ltd 0.0015 -25% 577297 $7,983,396 EEL Enrg Elements Ltd 0.0015 -25% 16582818 $6,507,557 VFX Visionflex Group Ltd 0.0015 -25% 199999 $6,735,721 HPC Thehydration 0.01 -23% 4074374 $4,982,912 WEC White Energy Company 0.035 -20% 212 $13,711,276 EXT Excite Technology 0.008 -20% 2685646 $20,726,419 MTB Mount Burgess Mining 0.004 -20% 409514 $1,758,513 OEL Otto Energy Limited 0.004 -20% 3458960 $23,975,049 SKK Stakk Limited 0.004 -20% 5016 $10,375,398 VRC Volt Resources Ltd 0.004 -20% 1463043 $23,423,890 ODY Odyssey Gold Ltd 0.019 -17% 5122049 $20,674,036 GUL Gullewa Limited 0.068 -17% 420322 $17,877,818 HMG Hamelingoldlimited 0.069 -17% 66142 $16,340,625 AMS Atomos 0.005 -17% 1700232 $7,290,111 In the news... Bowen Coking Coal (ASX:BCB) has signalled it's considering placing the Burton Mine Complex operation into a temporary pause if an effort to transition the project to an owner-operator model is unsuccessful. The company is exploring a range of options to fund the transition plan and provide immediate liquidity, but the most recent Resources and Energy Quarterly forecasts falling demand for met coal as low emissions steel production gains pace. Atomos (ASX:AMS) has launched a new employee incentive plan, with over half of the company's roll to be offered defined annual bonuses linked to share price performance. AMS says the incentives are a way to recognise the contributions of staff who worked tirelessly on minimal salaries over the last few years, and aligns employee interests with those of shareholders. IN CASE YOU MISSED IT Pure Hydrogen Corporation (ASX:PH2) has completed the handover of a Taurus hydrogen fuel cell prime mover to Barwon Water, Victoria's largest regional urban water corporation. Legacy Minerals (ASX:LGM) has wrapped up its first drilling campaign at the Thomson project, intersecting wide zones of quartz-sulphide mineralisation. Cyclone Metals' (ASX:CLE) power study has highlighted potential to power the Iron Bear project entirely with renewable energy. TRADING HALTS AIC Mines (ASX:A1M) – cap raise betr Entertainment (ASX:BBT) – off-market takeover offer for PointsBet GBM Resources (ASX:GBZ) – cap raise and board changes Great Boulder Resources (ASX:GBR) – cap raise New Murchison Gold (ASX:NMG) – Crown Prince project approvals update Victory Metals (ASX:VTM) – strategic alliance and funding facility Zenith Minerals (ASX:ZNC) – resource update for Dulcie Far North gold project LAST ORDERS Hillgrove Resources (ASX:HGO) is ahead of schedule on development efforts at the Nugent underground, hitting the orebody at the Kanmantoo copper mine earlier than expected. It's the first development ore produced at the Nugent underground operation, marking an important milestone toward formal ore production.
News.com.au
06-06-2025
- Business
- News.com.au
Scott Power: ASX health stocks dip but it was a good news week for EMVision
ASX health stocks dipped 0.82% over the past five days while the broader market has risen 1.26% EMVision appoints Ramsay Health Care CEO to board and expands sites of pivotal trial First Japan site opens for Dimerix's phase III clinical trial of DMX-200 in rare kidney disease Healthcare and life sciences expert Scott Power, who has been a senior analyst with Morgans Financial for 27 years, gives his take on the ASX healthcare sector for the week and his 'Powerplay' stock pick. Power said that, while healthcare markets were down this week, broader markets remained elevated with things starting to look more positive at the halfway mark of a thus-far volatile 2025. US President Donald Trump's trade and health policies have been impacting the sector throughout the year. At about lunchtime on Friday the S&P/ASX 200 Health Care index was down 0.82% for the past five days, while the benchmark ASX 200 rose 1.26% for the same period. "The broader market is up this week and May was a reasonably good month," he said. "We are coming up to June 30 and the end of financial year so there will be some tax-loss selling coming through across various portfolios. "June tends to be a weaker month as investors look to clean up their portfolio, while July seasonally tends to be a stronger month and there is potentially some good value out there across the smaller names which really haven't done too much for the last couple of years." Ramsay CEO joins EMVision board, trial expands EMVision Medical Devices (ASX:EMV) has had two major announcements this week including the appointment of Ramsay Health Care (ASX:RHC) CEO Carmel Monaghan as non-executive director and broadening of a pivotal trial for its emu bedside brain scanner, which is designed to rapidly diagnose stroke. Monaghan has worked across hospital, corporate and global positions at Ramsay for almost three decades. "She is highly regarded and will bring a lot of credibility and contacts into the business," Power said. He said EMvision was also making good progress with the activation of its third US site, Mount Sinai Hospital in New York, scheduled for this month. Activation of its second Australian site, Liverpool Hospital in Sydney, has also been in progress this week. Five world-leading hospitals in stroke care are now taking part in EMVision's pivotal trial with a sixth set to be activated shortly. The pivotal (validation) trial is designed to support US Food and Drug Administration (FDA) de novo (new device) clearance of the emu point-of-care brain scanner device. "The expectation is that they will get approval sometime in 2026," Power said. Power's Powerplay: Big year for Dimerix Dimerix (ASX:DXB) is Power's stock of the week after announcing it had opened the first trial site in Japan for its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease. Opening of Japan's first clinical trial site for ACTION3 triggers the first development milestone payment of ¥400 million (~A$4.3m) to Dimerix from FUSO Pharmaceutical Industries Ltd, its exclusive licensee of DMX-200 for FSGS in Japan. FUSO is one of four regional licensing deals executed for DMX-200, which collectively provide up to ~$1.4bn in total upfront payments and potential milestone payments, plus royalties on net sales. FSGS is a serious kidney disease that causes progressive scarring, leading to permanent damage and, ultimately, end-stage kidney failure – often requiring dialysis or a transplant. It affects adults and children and no treatments are currently approved specifically for the condition anywhere in the world, affecting overall prognosis. As a result, DMX-200 has received orphan drug designation in both the US and Europe, along with the UK's equivalent designation under the Innovative Licensing and Access Pathway (ILAP). Dimerix last year reported positive interim results from the ACTION3 trial, showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date. Full enrolment in the ACTION3 study is expected by the end of 2025 with a further blinded interim analysis planned. "It's going to be a big year for Dimerix," Power said. Mayne Pharma takeover deal far from over Adelaide-headquartered pharmaceutical company Mayne Pharma (ASX:MYX) is continuing to do battle with its US-based suitor Cosette Pharmaceuticals after announcing on Wednesday it had received a notice "purporting to terminate" the $7.40 per share offer worth more than $600 million. The withdrawal comes after Cossette asserted that a "material adverse change" had occurred, and consequently freeing Cosette from its obligations under the scheme implementation deed (SID). The announcement sent the stock lower and came hours after Mayne put out another one telling the market it had not received a notice of termination, which sent its shares higher. On Thursday Mayne put out another announcement saying the scheme meeting would go ahead on June 18, as scheduled with the stock rising more than 7%. "Mayne Pharma directors continue to unanimously recommend that vote in favour of the scheme resolution at the scheme meeting, in the absence of a superior proposal," said chairman Frank Condella. However, the company needs a court decision to affirm its view that the "material adverse change" were not, in fact, material. "There is a fair bit more water to flow under the bridge with this one and it just looks very messy at the moment," Power said. ReNerve enters partnership to expand product range Biotech company ReNerve (ASX:RNV) this week announced it had entered a strategic partnership with US-based Berkeley Biologics LLC to develop and commercialise two new complementary tissue-based product ranges. The first range addresses the need for human dermal tissued, deeper layers of the skin often sourced from donors. The second product range will provide amniotic tissue products, which are known for their regenerative and healing properties. The products are set to be produced at Berkeley Biologics' California facility and launch before the end of CY25. ReNerve said the new products represent a natural extension of its existing sales activities, leveraging the same sales network and continuing to target the same surgeon and hospital customer base. The company said surgeons could incorporate additional tissue grafts when treating nerve injuries, enabling them to address both the damaged nerve and any associated trauma. "It is a strong indication that they're trying to build their sales momentum by expanding the product offering to the surgeons," Power said. "Sales are expected to grow over subsequent quarters." The views, information, or opinions expressed in the interview in th is article are solely those of the interviewee and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this article.
News.com.au
03-06-2025
- Business
- News.com.au
Health Check: Don't dis-May! ASX biotechs record strong year-on-year share gains
Medadvisor and Dimerix lead the valuation gains in a choppy month Emvision and Paradigm open more pivotal trial sites Capital raisings click over MedAdvisor (ASX:MDR) is the ASX hero biotech of an otherwise subdued May, stacking on more than 52% in market capitalisation for the month. The medication compliance group said it had found a probable buyer for its Australian operations, thus spurring the rally. This supersized effort eclipsed Dimerix's (ASX:DXB) 24% surge, on the back of its May 1 news of a US distribution deal for its putative kidney disease drug. The numbers are based on Biotech Daily's top 40 index, which records the performance of the biggest stocks. The newsletter also recorded the Big Four – CSL (ASX:CSL), ResMed (ASX:RMD), ProMedicus (ASX:PME) and Cochlear (ASX:COH) – separately. Overall, the top 40 eased 2.6%, with Avita Medical (ASX:AVH) leading the decliners with a 40% tumble and Imugene (ASX:IMU) shedding 37%. shares lost 6%, translating to $555 million of lost value. Don't dis-May But don't dis-May too much: the sector's still up 9.7% year on year, just eclipsing the overall market's 9.5% increment. The Big Four gained 2.6%, thanks to Pro Medicus's 21% rebound from subdued levels. Investors had to go beyond the top 40 for the best return: pot and psychedelic drug play Incannex Healthcare (ASX:IHL) climbed 300 per cent, albeit having plunged 80% in April. We're doing better than our American friends, with the Nasdaq Biotechnology Index shedding 4.2% for the month. The index is also down 7% over the past 12 months. On trial In trial news, EMvision Medical Devices (ASX:EMV) is poised to activate its third US site in its pivotal trial of its bedside stroke detection device, Emu. The site is at The Mount Sinai Hospital in New York, a recognised leader in stroke research and treatment. The company is activating its second Australian site this week, at Sydney's Liverpool Hospital (a large stroke referral centre). These activations will bring the total of sites activated in the pivotal (validation) trial to five. These include Houston's UTHealth and Memorial Hermann-Texas Medical Centre, Mayo Clinic in Jacksonville and the Royal Melbourne Hospital. The study aims for US Food & Drug Administration (FDA) clearance for Emu, under the new device route. Knees up Paradigm Biopharmaceuticals (ASX:PAR) has activated the first of 11 proposed sites, for the local leg of its phase III knee osteoarthritis trial. Melbourne's Sportsmed Biologic is the first site, with the treatment overseen by prominent sports physician Dr Philip Bloom. The other sites are in 'various stages of start-up and activation'. Meanwhile, 48 sites are in advanced preparation stages. The study is pitched at FDA approval for Paradigm's repurposed drug candidate, to treat the common and debilitating condition. Capital-raising corner While finding a dime in the sector remains difficult, companies are managing decent smaller raisings. Shrugging off its US reimbursement setback, Pacific Edge (ASX:PEB) today upsized its NZ$15 million placement to NZ$16 million, with the board accepting oversubscriptions. A NZ$5 million share purchase plan (SPP) is yet to come. The offer is priced at NZ10 cents a share, a healthy 20% premium to the 20-day weighted average price. The raising is partly to grow sales channels for its non-invasive bladder cancer assay Cxbladder, independent of US Medicare reimbursement. Pacific Edge's Medicare coverage ceased in April, after a code pertaining to genetic oncology testing was excised. Not surpisingly, the company wants to re-gain this funding via legal and other means of suasion. Also today, Recce Pharmaceuticals (ASX:RCE) said it had placed a $7.4 million shortfall from its recent entitlement offer. This takes total proceeds from its capital raising to $15.8 million. The funds will support the synthetic anti-infective outfit's phase III trials, in Indonesia and locally. The Indonesian study treats diabetic foot infections, while the local effort is for acute bacterial skin and skin structure infections. Meanwhile heart device play Cardiex (ASX:CDX) has raised $2.4 million in an insto placement at 4 cents a share, with a $4.1 million rights issue opening on Friday. And OncoSil Medical (ASX:OSL) has raised $6.7 million in a placement and hopes an SPP will reap another $2 million. The price is one-third of a cent, a circa 20% discount. The funds will support the Oncosil's eponymous pancreatic cancer targeted radiation device. Thirty geographies have approved the tool, including Europe and the UK. Best of British biotech Data analytics house Global Data reports that venture financing for UK biopharmaceutical companies doubled in the March quarter, to US$1.1 billion. This is the highest quarterly total since 2021. This foreign investment surge also highlights danger for the Brit 'Growing dependence on US capital and policy-driven cost pressures signal an urgent need to strengthen domestic investment for sustainable growth.'
