Latest Regulatory Submissions News

OncoSil Medical reports a remarkable 917% increase in quarterly cash receipts alongside promising clinical trial results and key European market entries, signaling robust momentum in its pancreatic cancer treatment rollout.

Ampol Limited reported a robust third quarter in 2025 with refinery margins hitting a notable high, offsetting volume declines and setting the stage for strategic growth.

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for chronic wound treatment and advances regulatory filings for its TR Pro+® product, while gearing up for a major commercial rollout in early 2026.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.

BlinkLab has completed its U.S. autism pilot study with strong diagnostic accuracy and expanded its pivotal FDA trial to seven leading research centers, positioning itself for regulatory submission in late 2026.

Fitzroy River Corporation reported steady royalty income for the June quarter and highlighted significant progress on several royalty projects, including government approvals for Buru Energy’s Rafael Gas Project and a major equity raise for Endura Mining’s Snowy River Gold development.

LTR Pharma has made significant strides towards its US market debut with ROXUS, bolstered by expert appointments and peer-reviewed clinical data validating its rapid-onset ED treatments.

Dimerix Limited reports solid progress in its Phase 3 trial for DMX-200 targeting rare kidney disease FSGS, backed by orphan drug status in Japan and a robust cash position. The company prepares to engage the FDA on new data supporting regulatory approval.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

Anteris Technologies has enrolled the first patients in its pivotal PARADIGM Trial, testing the DurAVR Transcatheter Heart Valve against leading competitors in a global study.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

EMVision Medical Devices has expanded its pivotal clinical trial sites, secured a $3 million government grant, and raised $14 million through placement and share purchase plan, positioning itself strongly for upcoming regulatory submissions and commercialisation.