Latest Regulatory Submissions News

Neurizon Therapeutics has inked a pivotal global licensing deal with Elanco Animal Health, unlocking critical intellectual property and data to accelerate the development and commercialisation of its lead drug candidate NUZ-001 for neurodegenerative diseases including ALS.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

West Cobar Metals has initiated approvals for a 5,000m air core drilling campaign at its promising Mystique Gold Project, aiming to unlock significant gold mineralisation in Western Australia’s Fraser Range.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.

Dimerix Limited has received a significant milestone payment from its Japanese partner FUSO Pharmaceutical, marking progress in the Phase 3 clinical trial of DMX-200 for kidney disease. This payment underscores the growing momentum behind Dimerix’s global licensing strategy.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Orthocell’s new study confirms Remplir™ delivers superior nerve regeneration and faster muscle recovery compared to traditional sutures, bolstering its US market rollout plans.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

Recce Pharmaceuticals has locked in a non-dilutive A$30 million debt facility with Avenue Capital Group, extending its cash runway to support pivotal Phase 3 trials and commercialisation of its synthetic anti-infective R327G.