Neurizon Therapeutics (ASX:NUZ) has reported positive topline results from the Open-Label Extension study of its lead candidate NUZ-001 for the treatment of amyotrophic lateral sclerosis, which is the primary form of motor neurone disease.

LTR Pharma said that the publication provides independent validation of SPONTAN's differentiated profile, showing peak plasma concentrations in approximately 10 minutes versus 45 minutes for conventional oral tablets.

Brandon BioCatalyst, a collaboration of more than 50 of Australia and New Zealand’s leading medical research institutes, hospitals and universities, today announced new board appointments.

Lucia Bio has announced that it has raised an additional $2 million in seed financing, bringing the total seed investment secured to date to $3 million.

Momentum Clinical Research and Pacific Clinical Research Network are merging to form Australasia’s largest, most integrated clinical trial network that can provide delivery capability from Phase 1 first-in-human to Phase 4 clinical trials.

“We showed very clearly that if you brush the cobwebs off, the gene comes on,” said Professor Merlin Crossley, UNSW’s Deputy Vice-Chancellor Academic Quality. “And when we added the methyl groups back, the gene turned off again. So these aren’t cobwebs — they’re anchors.”

The US FDA has informed Neurizon Therapeutics (ASX:NUZ) that a decision on its Clinical Hold Complete Response for the company's lead investigational therapy NUZ-001 is now not expected until 3 October 2025.

Leading voices in biotech, medtech, investment and policy came together in Sydney last week for the BioNSW Catalyst Dinner.

“Her pioneering work in human metabolism and diabetes laid the foundations for Novo Nordisk’s commitment to improving the lives of people with serious chronic diseases through science,” said the company's Dr Ana Svensson.

EMVision Medical Devices (ASX:EMV) has secured a significant boost in its mission to transform stroke care, with the Australian Government awarding the company $3 million in non-dilutive funding under the Cooperative Research Centres Projects Round 17 grant program.

Australian preclinical biotechnology company Mirugen has secured investor backing to progress the development of its (re)programming cells to unlock innate cellular repair mechanisms.

Firebrick Pharma (ASX:FRE) has announced that it has received acceptance of its COVID-19 patent by the European Patent Office.

AVITA Medical, a company in acute wound care, has successfully raised about US$15 million (~A$23 million) through a private placement of shares to investors in Australia.

Regenerative medicine company Orthocell (ASX:OCC) says commercialisation of its flagship nerve repair product Remplir in the US is progressing on plan, with early clinical use and steps to secure broader hospital adoption underway.

The letter details the additional information the FDA requires to lift the clinical hold on Argenica’s investigational new drug application for ARG-007, a therapeutic aimed at reducing brain tissue death after stroke.

In a move set to bolster investor engagement across Australia's life sciences sector, AusBiotech has announced the appointment of Kerri Lee Sinclair as its new Head of Investment.

Syntara CEO Gary Phillips said, "We will use the FDA guidance to refine our clinical development plan for amsulostat and continue discussions with partners based on the FDA recommended path forward."