Latest Regulatory Update News

The Foreign Investment Review Board has extended its deadline for approving Mayne Pharma's acquisition by Cosette Pharmaceuticals, maintaining the current transaction timetable for now.

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.

DroneShield Limited has retracted its recent announcement of $7.6 million in new U.S. Government orders, clarifying these were reissued contracts rather than fresh deals. The company is addressing the administrative error to prevent future confusion.

Aguia Resources advances its phosphate operations in Brazil with new funding and plant upgrades, while a management overhaul in Colombia reveals a significant gold discovery at Santa Barbara.

Dome Gold Mines reports steady progress on its Sigatoka heavy mineral sands project despite delays in a government-led river desilting program, while exploring funding options for its Nadrau copper-gold project in Fiji.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Challenger Limited reported a solid 4% increase in total Life sales to $2.5 billion in Q1 FY26, buoyed by strong annuity sales and strategic partnerships. The company reaffirmed its FY26 earnings guidance while highlighting upcoming regulatory changes expected to benefit the sector.

Fiducian Group Limited has reported a robust 23% increase in net profit after tax for the year ended June 2025, driven by strong inflows and resilient performance across its financial planning, platform administration, and investment management segments despite challenging market conditions.

Vanguard Investments Australia has announced the estimated distribution and tax components for its Vanguard FTSE Asia ex Japan Shares Index ETF for the quarter ending September 2025, highlighting key details for investors on cash payouts and tax implications.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

VGI Partners Global Investments has completed its on-market share purchases under the Dividend Reinvestment Plan, updating investors with a new Appendix 3A.1 filing.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.