Latest Clinical Development News

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Neurizon Therapeutics has secured trademark protection for its NEURIZON® brand across major pharmaceutical markets, reinforcing its intellectual property strategy as it advances its lead drug candidate NUZ-001.

Zelira Therapeutics has raised nearly US$33 million from ThirdGate Capital to advance its HOPE® 1 drug targeting autism-related Phelan-McDermid Syndrome through FDA clinical trials. This funding milestone sets the stage for pivotal regulatory progress in the US.

Argent BioPharma has signed a binding agreement to acquire AusCann’s 48% stake in CannPal, enhancing its clinical and intellectual property assets for CannEpil®. The deal includes an option for the Neuvis® drug-delivery platform and aligns with Argent’s U.S. dual-listing ambitions.

Racura Oncology has launched a strategic collaboration with Emory University to investigate (E,E)-bisantrene’s potential to overcome resistance to osimertinib in EGFR-mutated non-small cell lung cancer. This partnership aims to bolster Racura’s HARNESS-1 clinical trial and strengthen its position in the competitive lung cancer treatment landscape.

AVITA Medical reported solid 11% revenue growth in 2025 and secured a $60 million credit facility to fuel its next phase of expansion, projecting up to 19% revenue growth in 2026.

Island Pharmaceuticals has been granted a key US patent for Galidesivir, extending intellectual property protection through 2031 for treating filoviridae viruses including Marburg and Ebola. This milestone aligns with the company’s clinical development strategy and recent FDA regulatory progress.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

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.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

InhaleRx Limited has successfully closed its entitlement offer and placement, raising $857,730 to support the clinical development of inhaled treatments targeting cancer pain and mental health conditions.