AusBiotech

NuNerve is taking its lead motor neurone disease therapy into a national Phase 2 trial after early signs of disease stabilisation and functional improvement in its first human study.

Tetratherix has reworked its royalty arrangements with the University of Sydney, replacing a layered set of payment obligations with a single flat royalty that the company says will strengthen its margins as its first products approach market.

Nexsen says it aims to file its RenalSure bedside test for acute kidney injury with the US Food and Drug Administration in mid-2027. It has also started a feasibility study with Austrian company GENSPEED Biotech to evaluate a second, complementary test for the condition.

CLINUVEL managing director Philippe Wolgen has rejected calls from some shareholders for a share buyback. At the company's annual general meeting in Melbourne, he said the board would keep investing cash in research and a planned business transformation.

AVITA Medical has raised its full-year revenue guidance and removed the going concern qualification from its accounts after a third quarter in which revenue grew 53 per cent on the same period last year.

Miro Sciences, formerly NeuroScientific Biopharmaceuticals, has announced that it plans to start a randomised Phase 2 trial of its StemSmart cell therapy for people with severe Crohn's disease who have failed existing treatments. 

Executive Chairman Dr John Prendergast said Mr McKeough had served the company for over eight years. "He has made a lasting impact on the Company, both as a Director and as Chair of the Audit and Risk Committee."

Neuren's chief executive, Jon Pilcher, said the result positioned the company well beyond its home market. "The Neuren team is excited about the impressive performance of DAYBUE in Q3 2026 and an outlook that continues to strengthen."

Radiopharm Theranostics has reached agreement with the US Food and Drug Administration on the design of a single pivotal Phase 3 trial for RAD101, its imaging agent for brain metastases.

Island Pharmaceuticals has started surgical preparations on the 22 nonhuman primates that will take part in its Galidesivir dose optimisation study for Marburg virus disease.

OncoSil Medical has applied to regulators to manufacture its OncoSil device at a Macquarie Park, Sydney facility. The company said it hopes to start commercial production at the facility in the second half of the 2027 financial year.

The funds enable the Melbourne company to pay out its convertible note holder and avoid a further drawdown on that facility before its lead ALS drug reaches a pivotal trial readout next year.