Latest Regulatory Milestones News

Memphasys Limited has submitted its Felix™ sperm separation system for CE Mark approval, targeting Europe’s $5 billion IVF market, while expanding direct sales in Japan and validating its RoXsta™ oxidative stress diagnostic platform.

Diatreme Resources has achieved a significant milestone with its Northern Silica Project awarded Major Project Status and a 278% upgrade in its Si2 Deposit resource, positioning the company for long-term growth in the critical minerals sector.

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.

Arizona Lithium has secured regulatory approval for Phase 1 production at its Prairie Lithium Project in Saskatchewan and raised $4.25 million through an oversubscribed share purchase plan, marking key milestones toward commercial lithium extraction.

Prescient Therapeutics has secured FDA Fast Track designation for PTX-100 in treating relapsed Cutaneous T-Cell Lymphoma and dosed the first patient in its Phase 2a trial, supported by a recent $6.8 million capital raise.

CurveBeam AI reported a strong Q4 FY25 with record customer receipts and an 18% rise in purchase orders, while advancing key regulatory milestones and securing a major financing facility.

Magnetite Mines has increased its Razorback iron ore resource estimate and extended key partnership negotiations, advancing its flagship project’s development. The company also reported promising metallurgical testwork and drew down funding to support ongoing feasibility studies.

Viridis Mining and Minerals has raised AU$11.5 million through a heavily oversubscribed placement, strengthening its balance sheet to advance the Colossus Rare Earth Project towards Final Investment Decision. The funding, backed by institutional and strategic Brazilian partners, positions Viridis with nearly AU$58.5 million in cash to accelerate development and regulatory approvals.

ACDC Metals has reported strong scoping study results for its Goschen Central heavy mineral sands and rare earth project, highlighting a promising 14-year mine life and a strategic retention licence application to support ongoing development.

Chalice Mining reports robust cash reserves and steady progress on the Gonneville Project pre-feasibility study, while exploration in Western Australia uncovers promising new gold-copper anomalies.

Coda Minerals reports breakthrough metallurgical results at its Elizabeth Creek Copper-Cobalt Project, achieving copper recoveries up to 95.9% and advancing key environmental approvals.