Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
HeraMED to Deliver HeraCARE Hybrid Maternity Care Solution for Major US Health Network
HeraMED secures US$317k first-phase HeraCARE rollout with Lee Health System, kicking off commercial US expansion via SaaS, Epic EMR integration, 200 patients.
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Prescient Therapeutics Advances Lead Asset PTX-100 through Phase 2a Trials as Pharmaceutical Dealmaking Accelerates
Prescient advances PTX-100 in Phase 2a for CTCL; DOC review set for Dec 2026 as Prescient accelerates toward registration data amid booming pharma dealmaking.
Lumos Diagnostics Adds Four US Urgent Care Groups to FebriDx Blood Test Rollout
Lumos Diagnostics expands FebriDx rollout to 215 US sites; two major health-system groups move to deployment across 40+ sites as validation widens to 45 sites.
Entropy Neurodynamics Confirms Durable Clinical Response in TRP-8803 BED Trial
Entropy Neurodynamics reports durable 12-week BED response from TRP-8803, with 50% binge-free and 73% weekly episodes below baseline after two doses.
Immutep Refocuses Efti Development Following TACTI-004 Study Review
Immutep refocuses eftilagimod alfa on HNSCC (CPS<1) and neoadjuvant STS after TACTI-004 review; new 200L manufacturing, target H2 2027 trial start.
Cleo Diagnostics Selects Bio-Techne’s US Laboratory for Pivotal Ovarian Cancer Test Validation
Cleo Diagnostics taps Bio-Techne's US lab for pivotal validation of its pre-surgical ovarian cancer test ahead of a 510(k) FDA filing in H1 2027.
Optiscan Imaging Advances InForm Device with Digital Pathology Study
Optiscan Imaging advances ACL study, >80 cases imaged with InForm slide-free digital pathology, accelerating clinical validation and rollout.
Biome Australia to Launch Larger Format of Best-Selling Probiotics Range
Biome Australia unveils larger two-month probiotic formats, boosting stock-keeping units and onshore manufacturing to drive demand in 2027.
Echo IQ to Review Regulatory Path after EchoSolv HF Application Misses FDA Clearance
Echo IQ studies next steps after FDA finds EchoSolv HF 510(k) not substantially equivalent; will engage FDA directly while EchoSolv AS stays cleared.
Emyria Prepares First Sydney Clinic for September Launch
Emyria to open Sydney clinic in Sept 2026, expanding NSW reach; 20 therapists, 4 psychiatrists (2 authorised prescribers) ready; patients approved.
Dimerix Secures Non-Dilutive Funding for Key Kidney Disease Programs
Dimerix secures up to A$34m non-dilutive funding to progress two kidney programs; half drawn now, funding ACTION3 Phase 3 and DMX-652 Phase 2.
EMVision Medical Devices Prepares Study to Support Remote Use of emu Bedside Brain Scanner
EMVision moves to remote stroke care with emu bedside scanner; regional study protocol set, telehealth-enabled diagnosis could shift rural care (ASX: EMV).