Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
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.
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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.
Adherium: Scaling Digital Respiratory Care and Assessing the US Payer Opportunity
Adherium pivots to US RPM subscriptions, pursuing Value-Based Care contracts as iCARE validates cost savings; targets 10k shipments and 40k patients in FY2026.
BCAL Diagnostics Develops Blood Test for Breast Cancer Recurrence Monitoring
BCAL Diagnostics launches BREASTEST Monitor—blood test to monitor post-treatment breast cancer recurrence; 91% sensitivity, 95% NPV.
Actinogen Gets Third DMC Green Light for XanaMIA as November Topline Nears
Actinogen's XanaMIA gets third DMC green light; trial proceeds unchanged as November 2026 topline readout nears, easing near-term interruption risk.
Dimerix Engages Everest Medicines to Commercialise DMX-200 Kidney Disease Treatment across Asia
Dimerix inks exclusive DMX-200 FSGS deal with Everest in Asia; upfront $14.1m, potential milestones up to ~$466m and 15% royalties.