Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies

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.
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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.

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.