Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Optiscan Imaging Moves Closer to Regulatory Clearance of Real-Time Surgical Imaging Platform
Optiscan Imaging submits InVue for FDA 510(k) review, moving its real-time surgical imaging platform closer to US clearance and commercialisation.
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Dimerix Achieves First Patient Completion Milestone for DMX-200 Clinical Program
Dimerix’s DMX-200 program reaches a milestone as its first patient completes two years in the extension study, with 93% of eligible patients continuing.
Artrya Wins Five-Year US Commercial Deal with Huntsville Hospital Health System
Artrya lands five-year US deal with Huntsville Hospital Health System; minimum US$0.5m for Salix Coronary Anatomy SaaS, expanding its US footprint.
Syntara Expands Safety and Tolerability Study of SNT-9465 Topical Scar Treatment
Syntara expands Phase 1b trial for SNT-9465, adding 10 participants, new blinded design and Sydney site; top-line data due Q1 2027 to back an IND.
LTR Pharma Final Phase II Report Confirms Fast Absorption for Spontan Intranasal Spray in Treating ED
LTR Pharma's Spontan intranasal ED spray peaks in 10 minutes, six-fold faster than oral vardenafil; Phase II data complete, paving US licensing talks.
Vitrafy Life Sciences Expands Platelet Cryopreservation Program With Versiti Blood Health
Vitrafy Life Sciences expands platelet cryopreservation with Versiti; 94.4% post-thaw recovery from USAISR, two free units, US device listing aimed FY2027.
INOVIQ Defines EXO-OC Commercialisation Path after Independent Review
INOVIQ maps a 12–18 month path to US LDT for EXO-OC after independent review; aims for H1 2028 lab validation amid sample-handling variability.
Singular Health Group Signs Deal for Florida’s First State-Funded Medical Imaging Repository
Singular Health inks Florida deal for state-funded 3DICOM imaging repository with FIU, signalling first infrastructure revenue and potential Medicaid blueprint.
Nexsen Enters into Molecular GBS Diagnostic Joint Venture with FlashDx Shenzhen
Nexsen to form a 50:50 GBS diagnostic JV with FlashDx Shenzhen, targeting FDA 510(k) and EU IVDR clearance and APAC market entry.
BCAL Diagnostic Commences Phased Australian Rollout of Avantect Multi-Cancer Blood Test
BCAL Diagnostics begins phased Australian rollout of Avantect Multi-Cancer blood test, expanding early detection across NSW, Victoria and beyond.
Genetic Signatures and Microba Life Sciences Set Commercial Terms for Merger
Genetic Signatures and Microba agree all-scrip merger; MAP holders to own ~67% of the combined group at 0.654 GSS per MAP share; GSS remains ASX-listed.
Nyrada Raises Fresh Capital to Fund Xolatryp Phase IIa And Pipeline Expansion
Nyrada raises A$12m via placement to fund Xolatryp Phase IIa PROTECT-MI and pipeline expansion; targets a further A$2m via SPP, with board participation.