{"id":644722,"date":"2026-05-02T10:34:24","date_gmt":"2026-05-02T10:34:24","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/644722\/"},"modified":"2026-05-02T10:34:24","modified_gmt":"2026-05-02T10:34:24","slug":"asx-quarterly-health-wrap-clinical-milestones-dominate-as-late-stage-trials-advance","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/644722\/","title":{"rendered":"ASX Quarterly Health Wrap: Clinical milestones dominate as late-stage trials advance"},"content":{"rendered":"<p>ASX healthcare stocks kept climbing the clinical milestone ladder during the March quarter. Pic: Getty Images <\/p>\n<p>Entropy advances Phase II clinical trial of TRP-8803 for binge eating disorder<br \/>\nLTR\u2019s SPONTAN Phase II pharmacokinetic study fully recruits, with interim PK data expected in Q2 CY26<br \/>\nNeurotech initiates Phase III Beyond Harmony trial, while Singular Health expands its commercial footprint in the US<\/p>\n<p>\u00a0<\/p>\n<p>Quarterly reporting season is upon us once more for ASX-listed healthcare companies, with updates showing a mix of clinical momentum and financial discipline across the sector.<\/p>\n<p>This reporting period arrives against a more unsettled macro backdrop, with ongoing geopolitical tensions in the Middle East, macroeconomic pressures and broader market volatility.<\/p>\n<p>After a prolonged period of underperformance for parts of the healthcare sector, investors are watching closely for signs of genuine clinical progress translating into commercial traction.<\/p>\n<p>\u00a0<\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/entropy-neurodynamics-enp\/\" rel=\"nofollow noopener\" target=\"_blank\">Entropy Neurodynamics (ASX:ENP)<\/a><\/p>\n<p>Entropy progresses Phase II clinical trial using TRP-8803 for binge eating disorder\u00a0<br \/>\nSecures Australian patent protection for precision-controlled IV dosing method underpinning TRP-8803 through to 2042<br \/>\nEnded March quarter with $9.1 million in cash and funding facilities to support continued clinical execution<\/p>\n<p>Entropy has highlighted progress during the March quarter in its Phase II clinical trial using its lead IV therapy TRP-8803 for binge eating disorder (BED), alongside strengthened intellectual property protection and a solid funding position to advance ongoing development.<\/p>\n<p>During the quarter, the first treated patient treated with TRP-8803, alongside supportive psychotherapy, completed the four-week post-treatment assessment with top-line results demonstrating clinically meaningful improvements across multiple symptom domains.<\/p>\n<p>Cohort 1 of the Phase II BED trial completed enrolment of six patients in March with three already fully dosed and the remainder progressing through treatment.<\/p>\n<p>Top-line results are expected this quarter following completion of dosing and four week follow-up later this quarter.<\/p>\n<p>Supporting the program, Entropy also published peer-reviewed Phase 2a data for TRP-8802 (oral), showing an ~80% reduction in binge eating episodes sustained over follow-up, along with improvements in psychological and metabolic markers.<\/p>\n<p>In addition, the company secured Australian patent protection for its precision-controlled IV dosing method underpinning TRP-8803 through to 2042.<\/p>\n<p>Bolstering its cash position Entropy received ~$1.73 million refund under the Australian Government\u2019s R&amp;D tax incentive for FY25.<\/p>\n<p>The company ended the March quarter with $9.1m in cash and funding facilities to support continued clinical execution and upcoming trial activity.<\/p>\n<p>\u00a0<\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/ltr-pharma-ltp\/\" rel=\"nofollow noopener\" target=\"_blank\">LTR Pharma (ASX:LTP)<\/a><\/p>\n<p>LTR\u2019s SPONTAN Phase II pharmacokinetic study fully recruited with interim PK data on track for Q2 CY26 readout<br \/>\nPhase I SPONTAN data accepted for podium presentation at World Meeting on Sexual Medicine 2026<br \/>\nContinued commercial momentum for ROXUS US entry via FDA 503(a) pathway, alongside expanding real-world prescribing\u00a0<\/p>\n<p>LTR Pharma made solid progress across clinical development, commercialisation and real-world validation of its nasal spray therapy SPONTAN and ROXUS to treat erectile dysfunction (ED).<\/p>\n<p>During the quarter LTR progressed SPONTAN into the dosing phase of its Phase II pharmacokinetic (PK) study reaching full recruitment of 27 participants across three cohorts, with the final cohort progressing through a 15-day dosing phase.<\/p>\n<p>Interim PK results remain on track for release in Q2 CY26 and are expected to support the company\u2019s US Food and Drug Administration (FDA) 505(b)(2) regulatory pathway.<\/p>\n<p>Scientific confidence in SPONTAN was reinforced with Phase I data accepted for podium presentation at the World Meeting on Sexual Medicine 2026, highlighting faster absorption and improved bioavailability versus oral vardenafil, alongside a favourable safety profile.<\/p>\n<p>Real-world use under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) also continued to expand. Prescribing activity under the SAS has now exceeded 1,000 cumulative prescriptions, contributing to ongoing real-world evidence generation.<\/p>\n<p>During the quarter an independent observational case series reported positive real-world outcomes from SPONTAN use in five younger men experiencing erectile difficulties associated with performance anxiety.<\/p>\n<p>On the commercial front, LTR Pharma continued advancing its US strategy for ROXUS via the FDA 503(a) personalised medicine pathway, with partner discussions progressing and a disciplined focus on structuring long-term value-accretive agreements.<\/p>\n<p>Financially, the company remains well-positioned with a cash balance of $24.1m, no debt, and an estimated 13-quarter funding runway.<\/p>\n<p>\u00a0<\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/neurotech-nti\/\" rel=\"nofollow noopener\" target=\"_blank\">Neurotech (ASX:NTI)<\/a><\/p>\n<p>Neurotech starts Phase III Beyond Harmony trial evaluating NTI164 in paediatric patients with Autism Spectrum Disorder (ASD)<br \/>\nFirst clinical site initiated at Monash Children\u2019s Hospital and patient recruitment underway<br \/>\nDelivered strong preclinical validation with a 90-day GLP non-rodent toxicology study showing NTI164 was well tolerated with no mortality or dose-limiting toxicities<\/p>\n<p>Neurotech made progress in its Phase III Beyond Harmony trial evaluating its proprietary cannabinoid compound NTI164 in paediatric patients with Autism Spectrum Disorder during the quarter, with the first clinical site initiated and opened for recruitment.<\/p>\n<p>The first site to be activated, Monash Children\u2019s Hospital, is actively screening patients following receipt of all required regulatory approvals.<\/p>\n<p>This study represents a key step toward potential registration and future commercialisation of NTI164, with 150 patients planned under an adaptive trial design that allows for pre-specified modifications based on interim analyses.<\/p>\n<p>The Phase III program continues to expand, with additional clinical sites expected to come online in coming months as recruitment scales.<\/p>\n<p>Neurotech is also working with international clinical and regulatory experts to support study expansion and global alignment.<\/p>\n<p>In preclinical development, Neurotech reported strong safety outcomes from a 90-day GLP repeat-dose oral toxicity study of NTI164 in a non-rodent species.<\/p>\n<p>The study demonstrated no mortality or dose-limiting toxicities across all dose levels, with the compound well tolerated even at exposures ~10 times higher than the highest human dose evaluated to date.<\/p>\n<p>Importantly, any mild treatment-related findings were fully reversible, and no progressive or irreversible toxicities were observed.<\/p>\n<p>Neurotech also achieved a significant scientific milestone with the publication of clinical and mechanistic data in peer-reviewed Neurotherapeutics, the official journal of the American Society for Experimental NeuroTherapeutics.<\/p>\n<p>The journal reports results from a sub-cohort of patients enrolled in Neurotech\u2019s Phase I\/II open-label clinical trial in Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), alongside a comprehensive multi-omics analysis examining immune and epigenetic pathways.<\/p>\n<p>The study showed NTI164 delivered statistically significant improvements across all major disease domains in paediatric patients with PANS, alongside evidence of immune and epigenetic pathway normalisation.<\/p>\n<p>Neurotech also continued to advance its pipeline and strategic positioning, including a collaboration with the University of Sydney to explore NTI164 in Rett syndrome models and ongoing engagement with potential pharmaceutical and biotechnology partners.<\/p>\n<p>The company also maintained active investor engagement through media coverage, roadshows and conference presentations.\u00a0 It closed the quarter with cash and cash equivalents of ~$4.3m.<\/p>\n<p>\u00a0<\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/singular-health-group-shg\/\" rel=\"nofollow noopener\" target=\"_blank\">Singular Health Group (ASX:SHG)<\/a><\/p>\n<p>Singular Health expands US commercial footprint during March quarter with rollout of 500 additional 3DICOM MD\u00ae licences under its agreement with PNS<br \/>\nStrong growth in clinical and education adoption, including successful go-live of 3DICOM Patient at Life Radiology<br \/>\nFDA 510(k) clearance for the 3DICOM MD\u00ae Cloud platform, granted in January, expanding support to additional imaging modalities and strengthening regulatory positioning<\/p>\n<p>During the quarter Singular Health built on prior technical and commercial progress, successfully transitioned pilot programs into live clinical deployments, expanded its presence within the US education sector, and strengthened its position within emerging regulatory and interoperability frameworks.<\/p>\n<p>The company said these developments continued to reinforce its strategy of delivering scalable, interoperable imaging solutions across clinical, educational and enterprise environments.<\/p>\n<p>\u201cThe March quarter represented a period of strong execution for Singular Health,\u201d managing director and CEO Denning Chong said.<\/p>\n<p>\u201cAs we move into the next two quarters, we are focused on a number of key milestones, including finalising agreements with a US health plan, further demonstrating outcomes from our PNS deployment, and progressing potential expansion and renewal opportunities.\u201d<\/p>\n<p>On the commercial front, Singular Health\u2019s relationship with Provider Network Solutions (PNS) in the US continued to gather momentum, with the 500 3DICOM MD\u00ae licences deployed during the quarter across its primary care network with 750 licences now in total.<\/p>\n<p>A post-quarter payment of US$500,000 (~A$750,000) for licensing fees by PNS was made to Singular Health as per the binding enterprise agreement.<\/p>\n<p>Discussions with PNS are underway regarding potential expansion and renewal of licensing arrangements expected later in CY26.<\/p>\n<p>In parallel, Singular Health advanced its clinical rollout strategy, achieving full deployment of 3DICOM Patient Solution at Life Radiology in Miami.<\/p>\n<p>Clinical and administrative staff are now using the solution to retrieve radiological images including CT, MRI, PET, X-ray and mammography, along with associated reports and securely distribute them to patients and referring physicians.<\/p>\n<p>The company also strengthened its education and research footprint through a paid pilot with Miami-Dade County Public Schools and a strategic MoU with Florida International University.<\/p>\n<p>Both initiatives are designed to evaluate 3DICOM across training, clinical simulation and research environments, providing a pathway for broader adoption across US education and healthcare systems.<\/p>\n<p>Singular Health also achieved a significant regulatory milestone with FDA 510(k) clearance for its 3DICOM MD\u00ae Cloud platform, granted in January and within 40 days of submission.<\/p>\n<p>The cloud-based solution builds on the existing FDA-cleared desktop viewer, expanding support to additional imaging modalities, including X-ray and ultrasound alongside CT, MRI and PET to broaden clinical applicability across a wider range of care settings.<\/p>\n<p>Singular Health also contributed to a US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) request for information on diagnostic imaging interoperability.<\/p>\n<p>The company provided policy and technical input based on real-world deployment experience, including challenges such as Picture Archiving and Communication System (PACS) fragmentation, limited integration with electronic health records, and inefficiencies contributing to duplicate imaging.<\/p>\n<p>The submission positioned 3DICOM as a vendor-neutral solution aligned with emerging interoperability standards and future certification frameworks.<\/p>\n<p>\u00a0<\/p>\n<p>\ufeff\ufeff\u00a0<\/p>\n<p>At Stockhead, we tell it as it is. While Entropy Neurodynamics, LTR Pharma, Neurotech International and Singular Health Group are Stockhead advertisers, the companies did not sponsor this article.<\/p>\n","protected":false},"excerpt":{"rendered":"ASX healthcare stocks kept climbing the clinical milestone ladder during the March quarter. Pic: Getty Images Entropy advances&hellip;\n","protected":false},"author":2,"featured_media":644723,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[64,63,137,500],"class_list":["post-644722","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-au","tag-australia","tag-health","tag-healthcare"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/644722","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=644722"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/644722\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/644723"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=644722"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=644722"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=644722"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}