Latest Regulatory Milestones News

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.

Midway Limited’s shares have been suspended from trading following Federal Court approval of its acquisition by River Capital’s RCM BidCo Pty Ltd, marking a pivotal moment for the timber producer.

Australian Rare Earths Limited (AR3) has obtained South Australian Government approval to expand its Overland Uranium Project, gaining rights over an additional ~1,000km² and greenlighting immediate drilling on high-potential targets.

Wellnex Life has secured Therapeutic Goods Administration approval for its Liquid Paracetamol plus Caffeine Soft Gel, marking its fourth market authorisation and opening new revenue avenues.

Viridis Mining and Minerals has raised A$3.5 million through a placement to fund critical development milestones for its Colossus Rare Earth Element project, following a major resource upgrade.