Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Imricor Medical Systems Gains FDA Paediatric Clearances for NorthStar and Diagnostic Catheter
Imricor gains FDA paediatric clearance for NorthStar and Vision-MR, unlocking radiation-free iMR procedures for children across 250+ US hospitals.
Latest Stories — SECTOR DESK
Imugene Adds Second Complete Response in Azer-Cel BTKi Cohort
Imugene logs a second complete response within 24 hours in Azer-cel BTKi cohort, Day-28 CR in MCL after BTKi failure, following FL CR.
Biome Australia Reports Record $23.9m Sales Revenue for FY26
Biome Australia posts record FY26 revenue of $23.9m, up 30%, led by Activated Probiotics; onshore manufacturing deal boosts 2027 outlook.
INOVIQ to Rework EXO-OC Study Path after Sample Quality Setback
INOVIQ retools EXO-OC path after sample quality setback; expanded retrospective data invalid, shifting to single-site/prospective validation.
Saluda Medical Given FDA Approval to Market CAP24 Paddle Lead to US Neurosurgeons
Saluda Medical wins FDA approval for CAP24 paddle lead, expanding US SCS market; phased year-end launch to drive Evoke closed-loop growth.
Clarity Pharmaceuticals to Showcase SAR-bisPSMA Prostate Cancer Data at EANM Conference
Clarity Pharma 64Cu/67Cu SAR-bisPSMA data accepted for EANM, featuring oral presentation and a 700–800-patient dataset that could reshape prostate cancer care.
Visionflex Wins A$0.8m NSW Health Hardware Contract
Visionflex (ASX:VFX) wins A$0.8m NSW Health RPM hardware contract, signaling near-term revenue visibility as it pivots to recurring software revenue.
Racura Oncology Treats First Patient in Harness-1 EGFRm Lung Cancer Trial
Racura Oncology starts Harness-1 Phase 1 with first patient dosed for RC220 + osimertinib in EGFR-mutant NSCLC; early safety data awaited.
Inoviq Announces Rapid Tumour-Killing Activity in Study of CAR-Exosomes on Ovarian Cancer Cells
Inoviq CAR-exosomes show rapid in vitro ovarian cancer killing, ~90% in OVCAR-3/Caov-3 within 48 hours, eyeing first-in-human trials by 2028.
Avecho Biotechnology Advances Phase III Insomnia Trial to Full Enrolment Size
Avecho Biotechnology Phase III insomnia trial moves to full enrolment after DMB recommendation; no serious adverse events in first 244 participants.
CONNEQT Health Lodges FDA Pre-Submission for SphygmoCor Cloud in Push toward Software Model
CONNEQT Health lodges FDA Pre-Submission for SphygmoCor Cloud, its cloud SaMD pivot with 510(k) target in FY27; could unlock subscription/licensing revenue.
Recce Pharmaceuticals Advances Diabetic Foot Infection Trial to Pivotal Phase 3
Recce Pharmaceuticals expands diabetic foot infection trial to Phase 3, broadening recruitment and adding below-knee ulcers; dual Australia-Indonesia program.