Latest Therapeutics News

Prescient Therapeutics has secured a key regulatory milestone with the EMA granting Orphan Drug Designation for PTX-100 to treat cutaneous T-cell lymphoma, while expanding its Phase 2a clinical trial across multiple continents.

Noxopharm has successfully completed dosing in its HERACLES clinical trial for SOF-SKN™, demonstrating strong safety and tolerability. The company also secured a new overseas partnership and its first US patent for the Sofra platform.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Neurotech International has secured a Rare Pediatric Disease Designation from the FDA for its lead drug NTI164 targeting Rett syndrome, alongside publishing promising clinical data and raising $8.7 million to fuel further development.

Percheron Therapeutics has reported encouraging safety and efficacy signals from its HMBD-002 phase I trial, and outlined an innovative modular phase II trial design targeting multiple cancers in 2026.

Amplia Therapeutics reports encouraging clinical progress for its pancreatic cancer drug narmafotinib, with a 35% confirmed response rate in the ACCENT trial and FDA support for dose optimisation. The company also uplisted to the US OTCQB market and secured a key patent extending protection to 2040.

NeuroScientific Biopharmaceuticals has reported promising initial clinical responses from its StemSmart™ Special Access Program treating Fistulising Crohn’s Disease, while preparing for a pivotal Phase 2 trial in 2026.

AdAlta Limited has launched its 'East to West' cellular immunotherapy operations through a strategic collaboration with Shanghai Cell Therapy Group to co-develop BZDS1901, an innovative CAR-T therapy targeting mesothelioma and other solid cancers. The company also strengthened its balance sheet by raising $2.8 million via private placements and repaying key investment agreements.

Patrys Limited has expanded its therapeutic portfolio by acquiring Reliis Pty Ltd, adding a proprietary injectable asset targeting delirium with near-term clinical milestones. This strategic move complements its existing biologics platform and strengthens its financial position.

Argent BioPharma has restructured its acquisition of AusCann assets to sharpen its clinical focus and secured a substantial A$11 million financing facility, positioning itself for growth in 2026.