Latest Biotech News

AdAlta Limited and its subsidiary AdCella have partnered with Shanghai Cell Therapy Group to co-develop a pioneering CAR-T cancer therapy targeting solid tumours outside China. This collaboration aims to bring a novel, armored immunotherapy with promising clinical results to global markets.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

TrivarX has received $3.5 million in second-tranche placement funding, enabling advancement of its innovative Stabl-Im technology for early, non-invasive brain tumour detection. The funding supports manufacturing scale-up and regulatory preparations ahead of a planned Phase 1 clinical trial in 2026.

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.

BioMarin Pharmaceutical’s acquisition of Amicus Therapeutics for US$4.8 billion includes Dimerix’s US licensing agreement, promising significant milestone payments and royalties. This deal strengthens Dimerix’s position as it advances its Phase 3 kidney disease therapy.

Entropy Neurodynamics has successfully completed dosing the first patient in its TRP-8803 clinical trial for Binge Eating Disorder, marking a key milestone with controlled psychedelic infusion and safety clearance. Top-line results are expected in early 2026.

Immutep Limited reports robust progress in its pivotal Phase III TACTI-004 trial for advanced non-small cell lung cancer, with over 120 clinical sites activated across 27 countries including the US. Patient enrolment has reached 38% of the target, keeping key milestones on track.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

Memphasys Limited has restructured its leadership by eliminating the CEO role to back a direct-selling global commercialisation strategy for its Felix™ System, anticipating imminent CE Mark approval to enter the European IVF market.