Latest Regulatory Milestones News

Emyria Limited reports strong progress in its MDMA and psilocybin-assisted therapy programs alongside a successful $2.525 million capital raise, positioning the company for expanded mental health treatment services.

Ark Mines has delivered a significant upgrade to its Sandy Mitchell Rare Earths Project, including a new Mineral Resource Estimate and a completed Scoping Study confirming commercial viability. The company is now preparing for a Pre-Feasibility Study to expand resources and refine project economics.

Clarity Pharmaceuticals reports robust progress in its SECURE trial and secures FDA Fast Track Designation for its diagnostic agent 64Cu-SAR-bisPSMA, underpinning its growth and innovation in prostate cancer treatment.

Structural Monitoring Systems plc has raised $8.7 million and implemented a major cost restructuring, positioning itself for profitable growth with strong sales momentum in its avionics and sensor technology segments.

Opthea Limited reports steady progress in its Phase 3 trials for sozinibercept, a novel treatment for wet AMD, supported by a strong cash position and a recent R&D tax incentive.

Prescient Therapeutics has secured FDA clearance to initiate its Phase 2 PTX-100 trial for relapsed cutaneous T-cell lymphoma, alongside progress in its cell therapy platforms and a solid cash position bolstered by a recent R&D rebate.

Titanium Sands Limited has made significant progress in securing its Industrial Mining License for the Mannar Project in Sri Lanka, while preparing for a crucial funding placement to support ongoing development.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for Autosomal Dominant Optic Atrophy, marking a pivotal step in developing a treatment for this currently untreatable blinding disease.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

QEM Limited has marked significant progress in its Julia Creek Vanadium and Energy Project, securing key government approvals and raising $2.76 million to advance development and environmental studies.

Astron Corporation has made significant strides in developing its Donald Rare Earths and Mineral Sands Project, securing $14.5 million in funding and progressing towards a Final Investment Decision in 2025 amid key regulatory and operational milestones.

Kairos Minerals has unveiled a robust scoping study for its Mt York Gold Project, projecting strong financial returns and gearing up for a major drilling campaign to expand its 1.4 million ounce resource.