Latest Regulatory Progress News

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.

Paladin Energy Ltd (ASX:PDN) reversed prior losses with a net profit of US$5.3 million in FY2026, driven by a strong ramp-up of uranium production at Namibia's Langer Heinrich Mine and regulatory progress at its Canadian Patterson Lake South Project.

Cavalier Resources has chosen SSH Group as its preferred mining contractor for the initial oxide pit at the Crawford Gold Project, aiming to kickstart mining operations within the next year.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.

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.