ASX Quarterly Health Wrap: Licensing deals, clinical and commercial milestones | Stockhead
It's quarterly check up time for ASX healthcare companies. Pic: Getty imagesDimerix secures fifth licensing deal for DMX-200 with Everest Medicines covering Greater China, South Korea and key Southeast Asian. . .
It's quarterly check up time for ASX healthcare companies. Pic: Getty imagesDimerix secures fifth licensing deal for DMX-200 with Everest Medicines covering Greater China, South Korea and key Southeast Asian marketsEBR completes 46 WiSE implants in Q2 CY26, taking total US pilot and limited market release implants to 117Island start GMP manufacturing of Galidesivir to support pivotal Marburg studies under US FDA Animal Rule pathwayQuarterly reporting season continues for the ASX-healthcare sector, which after a tough period is starting to catch a bid, up more than 13% in June and up almost 7% in the past five days. Here’s some of the latest quarterly results. Dimerix (ASX:DXB)Dimerix managing director Dr Nina Webster described Q4 FY26 as a “transformational period” for the company, which signed itsfifth regional licensing agreement for lead asset DMX-200with Everest Medicines covering Greater China, South Korea and several other key Southeast Asian markets. Under the deal, Everest will develop and commercialise DMX-200 across the licensed territories, with Dimerix eligible to receive up to ~$481 million in development and sales milestones, plus tiered royalties on net sales. The transaction further strengthens the commercial validation of DMX-200, taking the aggregate potential value of Dimerix’s licensing agreements to approximately $1. 9 billion in milestone payments, in addition to royalties. Dimerix also progressed its pivotal ACTION3 Phase II study of DMX-200 in focal segmental glomerulosclerosis (FSGS), with an external blinded statistical review confirming the trial remains appropriately powered at greater than 90% to demonstrate a treatment effect for the primary proteinuria endpoint. Following the review, Dimerix and its commercial partners elected to continue ACTION3 through to the final proteinuria endpoint, with the company aiming to maximise the potential for a successful regulatory outcome. The adult cohort remains fully recruited, with 333 patients randomised and dosed across 21 countries. Post quarter, Dimerix expanded its kidney disease pipeline through the acquisition of DMX-652, a first-in-class USP30 inhibitor being developed for acute kidney injury (AKI). DMX-652 has completed Phase 1 studies and received US FDA clearance to proceed with Phase II development. Akey patent relating to DMX-652 has also been granted by the United States Patent and Trademark Office (USPTO). Dimerix also strengthened its balance sheet, securing a $10 million non-dilutive funding facility to support clinical development, pipeline expansion and commercial readiness activities. Combined with existing cash reserves and the expected Everest upfront payment, Dimerix is funded through completion of ACTION3 and initiation of the DMX-652 Phase II trial. Dimerix ended the quarter with A$16. 2 million in cash and continues negotiations for up to a further $40m in non-dilutive funding. “The June quarter was another transformational period for Dimerix,” Webster said. EBR Systems (ASX:EBR)EBR Systems continued to advance the limited market release (LMR) of its WiSE wireless cardiac pacing system during the June quarter, with growing physician adoption and hospital engagement supporting its US commercial rollout. The company completed 46 WiSE commercial implants during Q2 CY26, taking total implants across the pilot phase and LMR to 117. Of these, 87 implants were completed during CY26 to 30 June, which the company said reflected continued progress as its builds commercial experience across activated accounts. EBR signed 17 new purchasing contracts during the quarter, bringing total contracts signed to 52, while 26 additional physicians completed training. The company now has 90 trained physicians across 30 activated hospital sites. As the LMR matures, EBR is shifting its focus from expanding the number of sites and trained physicians towards increasing utilisation within existing accounts,More than half of activated sites have now completed three or more WiSE implants, supporting repeat procedural experience and commercial adoption. EBR reported continued demand for WiSE, with encouraging patient identification and scheduling activity expected to support further implant growth in H2 CY26. The company expects Q2 revenue of US$2. 5m to US$2. 6m, subject to final quarter-end adjustments. During the quarter, EBR strengthened its funding position partially completing a fully underwritten $150m capital raise, with the final $35m tranche expected to be completed by August 24. Proceeds supporting EBR’s US commercial expansion, manufacturing scale-up, cost reductions, ongoing R&D, along with pathway to cashflow breakeven. The company also made progress on reimbursement and hospital access, with CMS initiating the National Coverage Determination process for WiSE. EBR secured purchasing agreements with major US healthcare networks including HCA Healthcare, Advocate Health and CHRISTUS Health. Investor and industry engagement remained strong during the quarter, with clinical data presented at Heart Rhythm 2026 in April highlighting improvements in real-world outcomes. Data from early US commercial implants showed the complication rate had fallen to 10%, compared with 19. 1% in the SOLVE study. “Q2 was another successful quarter of commercial execution for EBR with continued progress across WiSE implant activity, purchasing contracts and physician training,” said EBR president John McCutcheon. Island Pharmaceuticals (ASX:ILA)Island Pharmaceuticals delivered significant progress across its Galidesivir program during the June quarter, advancing manufacturing, regulatory and development activities aimed at supporting its FDA Animal Rule pathway for Marburg virus disease. The company started GMP manufacturing of Galidesivir, an important step towards late-stage development and potential commercial readiness. The manufacturing campaign being undertaken by global contract research, development and manufacturing organisation PI Health Sciences (PIHS) supports planned pivotal studies, regulatory submissions and future biodefence opportunities, including potential government procurement programs. Island expanded its collaborationwith the US Army Medical Research Institute of Infectious Diseases (USAMRIID) through an updated Cooperative Research and Development Agreement (CRADA). The agreement confirms a planned dose optimisation study, expected to commence this quarter, with topline results targeted for Q4 CY26. The USAMRIID study will evaluate different Galidesivir dosing regimens and treatment timeframes to identify the optimal dose for the FDA Animal Rule pathway. One of the world’s leading bio-defence and high-containment infectious disease research organisations, USAMRIID is part of the Defense Health Agency (DHA) and The Geneva Foundation for Medical Research. Post-quarter Island executed a statement of work with Texas Biomedical Research Institute, establishing the second phase of its FDA-directed dose optimisation program for Galidesivir. Combined the programs will generate data from 32 non-human primates to strengthen future regulatory submissions. During the quarter, the US FDA granted Orphan Drug Designation to Galidesivir for post-exposure prophylaxis of Marburg virus, which provides potential regulatory and commercial benefits, including eligibility for market exclusivity upon approval. Following quarter end,Island secured regulatory and government approvals to provide Galidesivir to patients under compassionate use during Uganda’s Bundibugyo Ebola outbreak under the World Health Organization’s MEURI emergency framework. Beyond Galidesivir, Island continued to advance its broader antiviral pipeline, including strengthening intellectual property around ISLA-101 with a Singapore patent covering treatment of flavivirus infections including Dengue and Chikungunya. The company has also launched ISLA-6181, an oral prodrug program based on Galidesivir, expanding future antiviral opportunities. “We have continued building the complete clinical, regulatory, manufacturing and commercial framework required to maximise Galidesivir’s long-term value as a medical countermeasure for high-consequence viral threats,” said CEO Dr David Foster. Optiscan (ASX:OIL)Optiscan continued to build momentum across its regulatory, clinical and commercial programs during Q4 FY26, advancing preparations for planned FDA submissions for its InVue and InForm platforms in H2 CY6. The company’s clinical programs progressed, with the breast cancer study at Royal Melbourne Hospital moving beyond the halfway mark with 34 of 50 planned cases completed by June 30 and a second clinical site at Frances Perry House accelerating enrolment. Optiscan said results from the first 25 patients were “very positive” with “excellent images across healthy and malignant breast tissue” allowing the company to stay on track for the planned FDA submission. The company’s head and neck Cancer study and anatomical pathology study also continued to generate strong clinical data to support future regulatory submissions. Optiscan also progressed preparations for two US-based Mayo Clinic studies, with institutional approval received for the breast cancer study during the quarter. Institutional approval is underway for the head and neck cancer study. The full submission to Germany’s University Medical Centre Mainz ethics committee was approved during the quarter, clearing the way for clinical preparation and site initiation activities for an observational imaging study in gastrointestinal (GI) tissues at one of Europe’s leading gastroenterology centres. Alongside regulatory progress, Optiscan advanced commercialisation activities across its device portfolio, completing go-to-market planning, customer profiling, market opportunity modelling and sales frameworks for InSpecta, InVue and InForm. Post-quarter the companyformally launched InSpecta in the US marketat the American Veterinary Medical Association (AVMA) Convention, following completion of launch preparations in Q4 CY26. Optiscan completed its ISO 13485 surveillance audit with full compliance results during the quarter, which the company said provided further confidence in its FDA inspection readiness. The company also strengthened its operational infrastructure by internalising key IT functions and implementing enhanced cybersecurity, access control, patch governance and security awareness initiatives. It also boosted its clinical team with the appointment of four clinical research associates to support upcoming Mayo Clinic studies. Optiscan received $2. 537m in government grants and tax incentives during the quarter and invested $1. 936m in R&D, supporting clinical and regulatory activities ahead of planned FDA submissions for InVue and InForm. Managing director Dr Camile Farah said the company had entered FY27 with strong momentum across regulatory, clinical and commercial priorities. “As we enter FY27, Optiscan is continuing to enjoy clear-cut development momentum with another round of commercial and regulatory milestones set to soon be realised,” he said. “These include our planned InVue and InForm FDA submissions, continued commercial progress for InSpecta, and the expected commencement of the two US-based Mayo Clinic studies. ”This article does not constitute financial product advice. You should consider obtaining independent financial advice before making any financial decisions. At Stockhead, we tell it like it is. While Dimerix, EBR Systems, Island Pharmaceuticals and Optiscan are Stockhead advertisers, the companies did not sponsor this article.