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Latest news, analysis, and insights from ASX biotechnology companies

Argent BioPharma Licences CannEpil Globally in US$5.5m Debt-Clearing Transaction
Lead storyBiotechnology

Argent BioPharma Licences CannEpil Globally in US$5.5m Debt-Clearing Transaction

Argent BioPharma inks global CannEpil license with Splash Beverage, US$5.5m upfront debt-clearing, 15% royalty; boosts US growth and potential listing.

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Imricor Medical Systems Gains FDA Paediatric Clearances for NorthStar and Diagnostic Catheter
Biotechnology

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.

Imugene Adds Second Complete Response in Azer-Cel BTKi Cohort
Biotechnology

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
Biotechnology

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
Biotechnology

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
Biotechnology

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
Biotechnology

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
Biotechnology

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
Biotechnology

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.