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Latest news, analysis, and insights from ASX biotechnology companies

OncoSil Medical Receives FDA Exemption Approval for Targeted Radiation Device
Lead storyBiotechnology

OncoSil Medical Receives FDA Exemption Approval for Targeted Radiation Device

OncoSil wins FDA humanitarian device exemption for dCCA, unlocking US market ~1,000 patients/year and $80m TAM; launch set for H2 2027.

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LTR Pharma Reports 93% SPONTAN Response in Real-World ED Cohort
Biotechnology

LTR Pharma Reports 93% SPONTAN Response in Real-World ED Cohort

LTR Pharma reports 93% real-world ED response to SPONTAN in treatment-experienced men, largest cohort to date, fueling ROXUS US plans.

Austco Healthcare Extends Direct Sales Presence with Acquisition of Nurse Call Platform Reseller
Biotechnology

Austco Healthcare Extends Direct Sales Presence with Acquisition of Nurse Call Platform Reseller

Austco to acquire MCS, bringing nurse-call in-house; boosts direct sales, adds $1.88m revenue and $0.82m EBITDA, earnings-accretive.

AVITA Medical Lifts Guidance as Record Quarter Brings Cash Flow Breakeven into View
Biotechnology

AVITA Medical Lifts Guidance as Record Quarter Brings Cash Flow Breakeven into View

AVITA Medical lifts 2026 revenue guidance after record Q2 US$21.7m; eyes cash-flow breakeven in Q4 as RECELL-led growth broadens international reach.

Clarity Pharmaceuticals Adds Two Complete Responses to SECuRE Trial Data
Biotechnology

Clarity Pharmaceuticals Adds Two Complete Responses to SECuRE Trial Data

Clarity Pharma reports two new complete responses at 8GBq in SECuRE trial, boosting radiographic disease control to seven; PSA declines strong.

BlinkLab Reports Positive ADHD Assessment Results from European Dx2 Diagnostic Platform Study
Biotechnology

BlinkLab Reports Positive ADHD Assessment Results from European Dx2 Diagnostic Platform Study

BlinkLab reports ADHD Dx2 results: 82% sensitivity, 83% specificity in European study, signaling new smartphone-based diagnostic tool.

Entropy Neurodynamics Gains Ethics Approval for Eight-Indication TRP-8803 Trial
Biotechnology

Entropy Neurodynamics Gains Ethics Approval for Eight-Indication TRP-8803 Trial

Entropy Neurodynamics gains ethics approval for Phase 1b/2a eight-indication TRP-8803 basket trial; first dosing this quarter.

Amplia Therapeutics Partners with Eli Lilly in FAK-KRAS Combination Lung Cancer Trial
Biotechnology

Amplia Therapeutics Partners with Eli Lilly in FAK-KRAS Combination Lung Cancer Trial

Amplia Therapeutics partners with Eli Lilly for a Phase 1b/2b NSCLC trial of narmafotinib plus olomorasib, targeting KRAS G12C resistance and expanding market.

Paradigm Biopharmaceuticals Completes Phase 3 Enrolment Ahead of September Interim Analysis
Biotechnology

Paradigm Biopharmaceuticals Completes Phase 3 Enrolment Ahead of September Interim Analysis

Paradigm Biopharmaceuticals completes Phase 3 PARA_OA_012 enrolment for Zilosul in knee OA; interim analysis in Aug 2026; top-line results Q1 2027.