Latest Regulatory Submissions News

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.

Telix Pharmaceuticals returned to profit in H1 2026, driven by strong U.S. sales of Illuccix and Gozellix, a $40 million upfront from Regeneron collaboration, and expanded R&D investment.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

Recce Pharmaceuticals has secured ethics approval to add an active-controlled arm to its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, enabling head-to-head comparison against existing antibiotics.

American Uranium has launched extensive aquifer pump testing at its Lo Herma Mine Unit 1, reinforcing progress toward in-situ recovery development and feeding data into a Q4 2026 Scoping Study.

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

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.