Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Clinuvel Looking to Access Greater Market Share with Corporate Restructure and US Relocation
Clinuvel relocates HQ to US, trims up to 20% staff, refocuses on US pipeline; Nasdaq listing aims to boost US investor access and partnerships.
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Proteomics International Appoints Healius Exclusive Australian Distributor for Promarker Blood Tests
Proteomics inks exclusive Australian distributor deal with Healius for Promarker blood tests, enabling nationwide rollout by 2027; revenue not yet estimable.
Radiopharm Theranostics Reports Positive Results from RAD204 and RAD101 Trials
Radiopharm Theranostics reports durable partial response for RAD204 in Phase 1; RAD101 Phase 2b brain mets shows 93% MRI-PET concordance, 86% sensitivity.
Lumos Diagnostics Expands FebriDx Rollout Across Priority US Urgent Care Accounts
Lumos Diagnostics expands FebriDx rollout to 430 US urgent care sites across top accounts, targeting 2.6 million ARI visits annually—rapid expansion under way.
Optiscan Imaging Advances Head and Neck Cancer Study Ahead of Schedule
Optiscan Imaging pushes Stage 2 of head and neck cancer live-imaging study ahead of schedule, accelerating clinical validation and potential FDA submissions.
LTR Pharma Executes US Commercialisation Agreement with Shed DTC Platform
LTR Pharma inks US ROXUS deal with Shed; targets 150k units in year one via Mavrox telehealth—fast-acting 10-min onset.
Dimerix Expands Kidney Pipeline With Phase 2-Ready Acquisition
Dimerix expands kidney pipeline with DMX-652 acquisition; Phase 2-ready AKI therapy targets US$3.5b market, upfront US$5m plus up to US$292m milestones.
Argenica Therapeutics Reports ARG-007 Neuroprotection in Concussion Study
Argenica's ARG-007 delivers durable neuroprotection after repeat mild TBI in a concussion model, hinting at a disease-modifying therapy from a single dose.
EMVision Making Strong Progress with emu and First Responder Brain Scanners
EMVision advances emu brain scanner validation; recruitment milestones hit as ischaemia endpoint eyed to bolster FDA De Novo clearance and value.
Cyclopharm Secures 11-Site US Technegas Deployment with UH Cleveland
Cyclopharm to roll out Technegas at 11 UH Cleveland sites within weeks, expanding US footprint with immediate, recurring revenue from imaging procedures.
HeraMED Clears First Lee Health Digital Obstetrics Pilot Phase
HeraMED Phase 1 Lee Health digital obstetrics pilot validates HeraCARE; 44 patients, 92% adopt digital path; Phase 2 decision soon.
Neurotech International Granted FDA Clearance for US Paediatric Study of NTI164
Neurotech's NTI164 gets FDA IND clearance for US trial; kicks off PopPK study, paving global regulatory path ahead of potential autism therapy approvals.