Latest Regulatory Milestones News

Centaurus Metals has secured the final mining lease for its Jaguar Nickel Project in Brazil, clearing a major regulatory hurdle and moving closer to a Final Investment Decision and project development.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

Prescient Therapeutics has bolstered its cash reserves to $12.3 million following a $9.8 million capital raise, while progressing its PTX-100 cancer therapy through global Phase 2 trials with encouraging early lymphoma results.

Battery Age Minerals has received initial drilling approval for its maiden program at the El Aguila Gold-Silver Project in Argentina, setting the stage for resource definition and exploration growth in a prolific mining region.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Alligator Energy has begun construction of its Samphire Project Field Recovery Trial near Whyalla, marking a key step towards uranium production amid a strengthening market.

Immuron Limited has taken a significant step forward by submitting an Investigational New Drug application to the FDA for IMM-529, targeting Clostridioides difficile infection. The company aims to start Phase 2 trials in early 2026, addressing a critical unmet need in infectious disease treatment.

Macro Metals Limited confirms key permitting milestones and advances offtake negotiations for its Extension Iron Ore Project, targeting construction readiness by late 2026.

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.

Emu NL has lifted its trading suspension following the appointment of a new director, meeting regulatory requirements and restoring market confidence.

MAC Copper Limited has outlined the final timetable for its acquisition by Harmony Gold, including key dates for court approval, trading suspension, and shareholder payments.

The U.S. FDA has lifted the clinical hold on Neurizon Therapeutics’ lead drug candidate NUZ-001, enabling its entry into a major ALS platform trial set for Q4 2025. This regulatory milestone accelerates the company’s clinical development and opens doors for broader neurodegenerative applications.