Latest Biotech News

Nyrada has secured ethics approval to begin a pivotal Phase IIa trial of its drug Xolatryp, targeting heart attack damage. Patient dosing is set to start in March 2026 across multiple Australian hospitals.

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.