Latest Regulatory News

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

Hartshead Resources has submitted a revised development plan for its Anning and Somerville gas fields, featuring a superior export route via CalEnergy's Saturn Banks pipeline. Supported by a strong cash position and committed partners, the company is exploring innovative funding to optimise project economics.

Future Metals NL has confirmed significant copper-nickel-PGM mineralisation at its Eileen Bore Prospect, unveiling a newly defined 4.5km intrusion. The company also secured A$4.2 million through a placement and planned rights issue to advance development and explore strategic processing partnerships.

Opthea Limited has discontinued its wet AMD development program following Phase III trial failures, slashing its workforce by 65% amid ongoing financial uncertainty and negotiations with investors.

Winsome Resources navigates lithium market headwinds by optimizing capital, progressing the Adina Lithium Project’s regulatory and feasibility milestones, and expanding its strategic footprint with a high-grade cesium-lithium discovery and extended Renard acquisition option.

Australian Vanadium Limited reports significant progress across its vertically integrated vanadium strategy, with key project milestones, government approvals, and promising energy storage developments positioning it for growth.

Novatti Group Limited has achieved a key turnaround milestone by reporting positive cash EBITDA of $100k in Q3 FY25, alongside record quarterly revenue of $13.4 million and improved margins in its core Payments AU/NZ business.

Biome Australia is set to expand its Activated Probiotics range with two new products targeting vaginal health and perinatal care, tapping into a booming women’s health supplements market.

Anson Resources reports a successful pilot of Direct Lithium Extraction technology at its Green River project with 98% lithium recovery, while securing approvals for a 24-hole drilling program at its Yellow Cat Uranium-Vanadium project.

Dalaroo Metals has taken a strategic step into Greenland’s critical metals scene with an option to acquire the Blue Lagoon Zr-Nb-REE Project, while advancing promising base and copper metal prospects at its Lyons River Project in Western Australia.

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.