Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Pacific Edge Test Volumes Rise 2.7% in Q4 on Payer Expansion
Pacific Edge (PEB) Q4 test volumes rise 2.7% on payer expansion; eyes Medicare LCD draft by Sept 2026 as coverage broadens, signaling regulatory momentum.
Latest Stories
Imricor Medical Systems Advances US Strategy with Pediatric Label Expansion Submission
Imricor submits pediatric NorthStar label via 510(k) to FDA, targeting 250 US children's hospitals; clearance expected this quarter to drive US growth.
Amplia Therapeutics Halts AMPLICITY Trial Recruitment After Chemo-Related DLTs
Amplia Therapeutics halts AMPLICITY recruitment after DLTs with narmafotinib mFOLFIRINOX; pivots to new combos, delaying readouts and raising investor risk.
Firebrick Pharma Raises $1.5m to Advance Product Development and Commercial Expansion
Firebrick raises $1.5m via 31.9m shares at $0.047, 16.5% discount to VWAP with 1-for-2 options; Indonesia grants Nasodine approval, unlocking SE Asia growth.
Nexsen Awarded $1.2m Grant to Advance Strepsure Point-Of-Care Diagnostic in Asia-Pacific Markets
Nexsen awarded $1.2m grant to advance StrepSure GBS test in Asia-Pacific; Hong Kong as hub for validation, local manufacturing and near-term commercialization.
Optiscan Submits FDA Dossier for Inspecta Imaging Device Targeting Lucrative US Veterinary Market
Optiscan submits FDA dossier for InSpecta veterinary imaging, unlocking US$11.9B market with real-time, non-invasive imaging for pets.
Alterity Therapeutics Receives Positive FDA Feedback for ATH434 Phase 3 MSA Program
Alterity Therapeutics wins positive FDA feedback on ATH434 Phase 3 for MSA; End-of-Phase 2 meeting mid-2026; cash runway ~A$49.2m.
Algorae Pharmaceuticals Enters Second Drug Synergy Screening Program with Peter MacCallum Cancer Centre
Algorae launches second AOS2 synergy program with Peter MacCallum Cancer Centre's VCFG; 24 drug combos across cancers; six-month preclinical data.
Clinuvel Showcases AI-Powered Vitiligo Assessment Tool at AAD Conference
Clinuvel unveils AI Vitiligo Visual Algorithm at AAD 2026, linking VVA to CUV107 Phase III; H1 FY26 revenue +4%, PAT -26% on higher costs.
BCAL Diagnostics Accelerates Avantect Rollout via Sonic Healthcare and Healius Partnerships
BCAL Diagnostics speeds Avantect rollout as Sonic Healthcare and Healius expand access to pancreatic/ovarian cancer tests nationwide.
Clarity Pharma Secures Key Supply Deal to Boost Commercialisation of Prostate Cancer Agent
Clarity Pharmaceuticals inks Theragenics Cu-64 deal to scale US manufacturing for 64Cu-SAR-bisPSMA ahead of FDA NDA, boosting commercialization.
BlinkLab Commences Pivotal FDA 510(k) Validation Program with First Participant Enrolment
BlinkLab kicks off pivotal FDA 510(k) validation for Dx1 autism diagnostic aid; first participant enrolled as an 8-month study targeting end-2026 submission.