Latest Regulatory Progress News

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

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.

Audalia Resources plans a $450,000 share placement to advance its Medcalf project and bolster working capital, while continuing to explore further funding options for regulatory approvals.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

KTEK Aerosystems has obtained a key export licence from the Netherlands, enabling it to ship components to its US facility for assembly and delivery. This milestone solidifies the company’s trans-Atlantic supply chain and supports its targeted September delivery restart.

Alterity Therapeutics has won a new US composition of matter patent for its lead drug ATH434, extending intellectual property protection to at least 2045 and boosting its commercial potential ahead of Phase 3 trials in Multiple System Atrophy.

Flynn Gold is kicking off a 2,500m drilling campaign at its Brilliant Prospect in northeast Tasmania, aiming to convert promising trench assay results into a formal Mineral Resource and fast-track project development.

BetMakers Technology Group has inked a binding deal for Tabcorp to acquire it at a 45.5% premium, valuing the wagering tech firm at about $283 million. Shareholders can opt for cash or a mix of cash and Tabcorp shares, with completion aimed for Q3 FY27.

Philips has officially declared compatibility for Imricor’s interventional MR devices with its magnetic resonance systems, enabling commercial clinical use and collaboration at a leading cardiology congress.

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.

Southern Cross Gold has updated its Sunday Creek project’s Exploration Target to between 3.0 and 4.6 million ounces gold equivalent, supported by ongoing drilling and promising metallurgical results.