Latest Regulatory Milestones News

Telix Pharmaceuticals has gained UK MHRA approval for Illuccix, its advanced prostate cancer PET imaging agent, promising to alleviate supply shortages and improve diagnostic accuracy across the UK.

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Poseidon Nickel Limited’s shares have been suspended from trading following court approval of Horizon Minerals’ acquisition scheme, marking a pivotal step in the nickel miner’s corporate evolution.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

BlinkLab has secured North Shore Pediatric Therapy as the second US clinical site in its autism diagnostic study, enhancing recruitment and data quality with a leading Chicago-based specialist.

CLINUVEL has released preliminary data from its CUV052 study showing SCENESSE® is well tolerated in adolescent erythropoietic protoporphyria (EPP) patients, supporting a planned label extension in 2025.

Cleo Diagnostics has responded to an ASX price query following a notable rise in its share price and trading volume, underscoring its patented ovarian cancer detection technology and ongoing U.S. clinical trials.

Neuren Pharmaceuticals has received a significant cash inflow of approximately US$50 million following the sale of a Priority Review Voucher linked to its Rett syndrome treatment. This milestone underscores the growing value of Neuren’s neurological drug portfolio and its partnership with Acadia Pharmaceuticals.

Medallion Metals has secured a positive EPBC Referral decision for its Ravensthorpe Gold Project, marking a crucial milestone in its sulphide development strategy. The company aims to submit additional environmental data by March 2025, targeting final approval by Q3 2025 while progressing drilling and financing.

AdAlta Limited is accelerating its 'East to West' cellular immunotherapy strategy, aiming to bridge Asian innovation with Western clinical development and manufacturing to target solid cancers. The company plans to secure three assets by the end of 2025 and initiate clinical trials, positioning itself as a leader in this emerging market.

Blackstone Minerals is set to merge with IDM International, combining expertise and local presence to advance exploration of the world-class Mankayan copper-gold porphyry project in the Philippines.

Pure Hydrogen has handed over Australia’s first hydrogen fuel cell rear loader garbage truck to Solo Resource Recovery, marking a milestone in sustainable waste management and clean energy adoption.