Latest Regulatory Filings News

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Clinuvel Pharmaceuticals marked its tenth consecutive profit with stable revenues and rising cash reserves, while accelerating U.S. expansion including a Nasdaq uplisting and potential ASX delisting.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

Neuren Pharmaceuticals reported an 8% rise in H1 2026 revenues driven by DAYBUE royalties, but profit fell 68% due to ramped-up R&D. The company declared its first ever dividend, signalling confidence amid ongoing clinical and regulatory milestones.

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%.

A2MP Investments has pushed back the deadline for its takeover bid for Canyon Resources, giving shareholders more time to review key documents amid ongoing conditionality.

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.

Forrestania Resources and Zenith Minerals have formalised an amended takeover implementation deed, setting out detailed terms for Forrestania's bid including offer ratios, board changes, and break fees.