Latest Regulatory Progress News

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug candidate NUZ-001 and strengthened its balance sheet with a $5.2 million capital raise. The company is now poised to enter the pivotal HEALEY ALS Platform Trial, marking a significant step forward in its neurodegenerative disease program.

Jindalee Lithium is progressing its McDermitt Lithium Project with a proposed US SPAC listing, government backing, and an $8 million capital raise, positioning it as a key player in the US critical minerals landscape.

Percheron Therapeutics reports encouraging phase I clinical results for HMBD-002, confirming safety and early efficacy signals, while gearing up for a multi-arm phase II trial in 2026.

Mach7 Technologies reports a pivotal first quarter for FY26, marked by the initial go-live of a major U.S. Veterans Health Administration contract, leadership changes, and a strategic business reset.

ACDC Metals reports promising mineralogy results from its Goschen Central Project, highlighting valuable rare earth elements and heavy minerals. The company maintains a solid cash balance and advances its retention licence application, positioning itself well in the evolving rare earth sector.

Bio-Gene Technology Limited reports significant progress in Q1 FY26, unveiling new product opportunities and positive efficacy data, alongside securing US Department of Defense grants.

Silver Mines Limited progresses regulatory approvals for its flagship Bowdens Silver Project in NSW, secures $34 million through capital raising, and acquires promising US exploration assets, setting the stage for growth.

Orpheus Uranium has advanced its exploration agenda by finalizing multiple Native Title Mining Agreements across South Australia and the Northern Territory, while strategically acquiring the Oobagooma Project in Western Australia to diversify its uranium asset base.

Far East Gold reports a productive September quarter with significant drilling results at its Idenburg Project, including a new high-grade discovery at North Bermol and an expanded pipeline of exploration targets.

Echo IQ Limited has advanced its EchoSolv heart failure solution towards FDA submission, driven by a landmark clinical validation study and a sharp rise in US platform adoption. Strategic partnerships and international expansion efforts underscore the company’s growing footprint in cardiology AI.

Cobalt Blue Holdings advances its Kwinana Cobalt Refinery with a critical Works Approval and secures letters of intent covering 70% of initial production, while its Broken Hill Cobalt Project gains a three-year Major Project Status extension.

Bioxyne Limited has reported a record-breaking first quarter for FY26, with revenues soaring 210% year-on-year, driven by strong demand in cannabis products and strategic European market advances.