Latest Regulatory Milestones News

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

Boab Metals has secured a six-year diesel supply deal with Cambridge Gulf subsidiary CGL Fuel, ensuring fuel reliability for Sorby Hills as it advances toward production in late 2027.

VHM Limited has ditched its Shenghe Resources offtake agreement to broaden market options and approved a direct jump to full-scale 5Mtpa development at its Goschen Rare Earths and Mineral Sands Project. Key regulatory approvals and a major drilling campaign underpin progress towards a mid-2026 Final Investment Decision and production slated for late 2027.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Wia Gold is making steady progress on its Kokoseb Gold Project in Namibia, reporting strong high-grade drilling results that bolster underground mining prospects alongside ongoing feasibility studies and strategic leadership appointments.

Leeuwin Metals has secured Mining Lease M77/1300 over the Evanston deposit, marking a crucial step toward development at its Marda Gold Project. All current Mineral Resources at Marda now reside on granted leases, underpinning future production plans amid ongoing exploration.

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.

Macarthur Minerals (ASX:MIO) has clarified the timing of its cleansing notice relative to a key Programme of Work approval, affirming compliance with ASX continuous disclosure rules and explaining the rationale behind delayed disclosure.

Predictive Discovery and Robex Resources have completed all merger steps except the final administrative confirmation from Quebec, bringing the combined West African gold producer closer to operational integration.

Neurizon Therapeutics has secured an additional A$2.7 million through a placement addressing the shortfall from its entitlement offer, lifting total proceeds to approximately A$8.5 million. This fresh capital strengthens the biotech’s balance sheet and provides financial flexibility as it advances its lead ALS drug NUZ-001 through pivotal clinical stages.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

Immutep Limited has won FDA Orphan Drug Designation for its immunotherapy eftilagimod alfa in treating soft tissue sarcoma, opening regulatory incentives and potential market exclusivity. This follows encouraging Phase II data despite recent Phase III trial setbacks.