AusBiotech

Argenica Therapeutics (ASX:AGN) has unveiled compelling new evidence that its neuroprotective drug candidate, ARG-007, delivers a significant clinical benefit to patients with the most severe forms of acute ischaemic stroke.

OncoSil Medical’s CEO and Managing Director, Nigel Lange, said, “This first commercial treatment in the UK is an important step forward for OncoSil and for patients living with pancreatic cancer.”

A major step forward in ALS drug development has arrived for Neurizon Therapeutics (ASX:NUZ), with the US Food and Drug Administration clearing the company’s lead candidate, NUZ-001, to enter the HEALEY ALS Platform Trial.

For LTR Pharma Executive Chairman Lee Rodne, the clearance marks a meaningful step forward in advancing a treatment designed with a particularly underserved population in mind.

Australian immunotherapy developer Immutep (ASX:IMM) has secured one of the most significant commercial partnerships in its history, signing a strategic collaboration and exclusive licensing agreement with India’s Dr. Reddy’s Laboratories for the development and commercialisation of its lead drug candidate, eftilagimod alfa (efti), across most global markets.

Australian scientists have identified, for the first time, specific genetic changes that sharply increase the risk of the most sight-threatening forms of age-related macular degeneration, offering a crucial lead for developing new therapies that could intervene before irreversible vision loss occurs.

CSL has released landmark five-year clinical results for its gene therapy HEMGENIX, confirming long-term durability, safety, and substantial clinical benefit for adults living with haemophilia B.

Telix Pharmaceuticals (ASX:TLX) has taken another step in its push to bring novel radiopharmaceutical therapies to men with advanced prostate cancer, confirming that the first patient has now been treated in the randomised expansion phase of its pivotal ProstACT Global Phase 3 trial.

Imugene (ASX:IMU) has taken a significant step toward potential commercialisation of its allogeneic CAR-T therapy azercabtagene zapreleucel, after receiving supportive written minutes from the US Food and Drug Administration outlining a clear route to a Phase 3 registrational trial.

Chimeric Therapeutics (ASX:CHM) has achieved a significant regulatory milestone, announcing it has secured FDA Orphan Drug Designation for its lead candidate, CHM CDH17, in the treatment of gastric cancer.

Algorae Pharmaceuticals (ASX:1AI) has taken a step forward in proving the real-world capability of its AI-driven drug-combination engine, following the release of independently generated validation data from the Peter MacCallum Cancer Centre.

CMAX Clinical Research has been recognised on the national stage, winning the 2025 Australian Export Award for Professional Services and cementing its position as one of Australia’s most influential contributors to global early-phase clinical research.