Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
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.
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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.
Cyclopharm to Install Technegas Platform in University of Pennsylvania Health System Network
Cyclopharm inks multi-site UPHS deal to roll Technegas across 11 locations, starting at UPenn. Major US expansion milestone with recurring revenue potential.
Cleo Diagnostics Optimises Biomarker Panel for Ovarian Cancer Blood Test Ahead of FDA Submission
Cleo Diagnostics expands ovarian cancer blood test biomarker panel to eight ahead of FDA submission, boosting robustness and paving US market entry (ASX: COV).
Amplia Therapeutics Reports Stronger Efficacy and Survival in Pancreatic Cancer Trial
Amplia Therapeutics reports ACCENT trial: 7.8% CR, 35.9% ORR, 11.1-month median OS in pancreatic cancer; trading halt ahead of AACR.
EVE Health Increases Capital Raising to $1.3m with $400,000 Cornerstone Investment
EVE Health Group lifts capital raise to $1.3m with $400k cornerstone, signalling reformulated-drug strategy and new science adviser amid Libbo launch.
Orthocell's Remplir Device Used in 23 Ukrainian Soldier Surgeries, Validating Field Utility
Orthocell's Remplir validated after 23 Ukrainian surgeries, boosting defence-market traction and global expansion; HY26 revenue +49%, cash ~A$49m.
DorsaVi Advances Ultra Edge Platform with New Partnerships and Key Milestones
DorsaVi secures Ultra Edge boost: Dr Patel and SEROMA total A$200k in deals, validating on-device AI and advancing 22-nm RRAM progress.
Tetratherix Expands Tetramatrix Platform with Precision Medicine Franchise and US Partnership
Tetratherix launches precision medicine franchise via Tetramatrix; signs exclusive US$3m/year deal with Superpower Health for 10 years.
BlinkLab Completes Pivotal FDA Study Site Network Ahead of Q1 2026 Trial Start
BlinkLab completes 10-site pivotal FDA study network ahead of March 2026 start; pilot 83.7%/84.7%; 510(k) submission H2 CY2026.
Racura Oncology Advances Lung Cancer Program with HARNESS-1 Trial Approval
Racura Oncology wins HARNESS-1 Phase 1a/b governance approval for RC220/osimertinib in EGFR-mutant NSCLC, enabling site initiation and recruitment.
Immutep Discontinues TACTI-004 Phase III Trial Due to Futility
Immutep halts TACTI-004 Phase III in first-line NSCLC due to futility; shares resume trading as cash runway extends beyond Q2 CY2027.