Latest Regulatory Submissions News

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.

Neuren Pharmaceuticals saw a record Q2 with DAYBUE net sales hitting US$125 million, driven by strong uptake of the new STIX formulation. The company upgraded its 2026 royalty guidance following Acadia Pharmaceuticals’ sales boost and awaits key regulatory milestones in Europe and Japan.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Jade Gas Holdings has secured regulatory approvals for Mongolia’s first coal bed methane reserves, completed a A$12 million capital raise, and signed a non-binding A$1.1 billion collaboration agreement to fund initial development of its Red Lake gasfield.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Paradigm Biopharmaceuticals has strengthened its balance sheet with a combined $5.75 million cash inflow from Australian Government R&D tax incentives, supporting its pivotal Phase 3 osteoarthritis trial and regulatory efforts.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

Recce Pharmaceuticals secured a non-binding term sheet with a major Middle Eastern pharma for its diabetic foot infection treatment and raised A$4 million to fund pivotal Phase 3 trials in Australia and Indonesia.

Orbminco has completed key drilling and metallurgical milestones at Majestic North, keeping its development timeline on track for a September Mining Development and Closure Proposal lodgement and final investment decision.