Latest Regulatory Pathways News

PYC Therapeutics has secured regulatory approval to initiate human trials of PYC-003, a novel drug candidate targeting the root cause of Polycystic Kidney Disease (PKD). Initial safety and efficacy data are expected within 2025, marking a critical step in addressing a disease affecting millions worldwide.

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.

Lithium Energy Limited has obtained final Environmental Impact Assessment approvals for key Solaroz concessions, paving the way for the next phase of lithium exploration and evaluation in Argentina.

Equinox Resources reports robust quarterly progress across its global portfolio, highlighted by exceptional drill results at Mata da Corda and Alturas, underpinned by a solid $2.2 million cash position.

Amplia Therapeutics has completed enrolment for its ACCENT Phase 2a trial in advanced pancreatic cancer two months early, reporting encouraging partial response rates and improved patient outcomes.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.

Control Bionics has delivered its strongest US sales quarter in years, nearing US$1 million in revenue, while broadening its market footprint with new commercial agreements and cost optimizations.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

Alterity Therapeutics has reported positive Phase 2 results for ATH434, showing significant slowing of Multiple System Atrophy progression and a favorable safety profile. The trial demonstrated clinical benefits alongside reductions in brain iron accumulation, a key disease driver.

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.

Dome Gold Mines reports steady progress on its Sigatoka industrial sand and magnetite project alongside securing a key government contract for emergency river desilting in Fiji. Exploration results also highlight promising copper and gold anomalies at its Nadroga tenement.

Silver Mines Limited has secured $25 million in funding and released an updated Ore Reserve and Optimisation Study for its flagship Bowdens Silver Project, reinforcing its position as a leading silver developer in Australia.