Latest Regulatory Milestones News

Clarity Pharmaceuticals has secured a second FDA Fast Track Designation for its 64Cu-SAR-bisPSMA diagnostic agent, aiming to revolutionize prostate cancer imaging and speed regulatory approval.

DeSoto Resources has secured a strategic manganese project in Brazil and received pioneering drilling approvals in Australia's Northern Territory, setting the stage for significant exploration activity in 2025.

Memphasys Limited marks a pivotal quarter with the completion of clinical trials for its Felix™ System, strategic market expansions in Greater China and the Middle East, and a successful capital raise to fuel growth.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

Chalice Mining reports a robust cash position of approximately $90 million and no debt as it progresses the Gonneville Project towards a targeted Final Investment Decision in 2027. The appointment of Dan Brearley as COO signals strengthened operational leadership amid ongoing metallurgical testwork and exploration activities.

Latin Resources Limited will be suspended from ASX trading following court approval of its acquisition by Pilbara Minerals Limited, marking a significant consolidation in the Australian minerals sector.

Recce Pharmaceuticals has successfully dosed all patients in its Phase II trial of RECCE® 327 topical gel for acute bacterial skin infections, showing encouraging preliminary efficacy and safety data. The company is preparing for pivotal Phase III trials in Australia and Indonesia, targeting a significant global market opportunity.

Iron Road Ltd has secured a $3 million milestone payment from Amp Energy and made significant progress on its Cape Hardy Industrial Port Precinct and Central Eyre Iron Project slurry pipeline study, reinforcing its strong cash position and strategic development plans.

Boab Metals has locked in a US$30 million prepayment facility with Trafigura for its Sorby Hills Lead-Silver-Zinc Project and received key environmental approvals, setting the stage for a final investment decision in the second half of 2025.

Agrimin Limited has achieved a major regulatory milestone with Western Australia's environmental approval for its Mackay Potash Project, advancing its path toward sustainable fertiliser production.

PolyNovo Limited reports a robust 22.8% revenue increase in 1H FY25, driven by strong U.S. and international sales growth and progressing FDA approval efforts for its NovoSorb platform.

Visioneering Technologies reports promising interim results from its PROTECT trial, showing significant control of myopia progression in children using NaturalVue® Multifocal lenses.