Latest Regulatory Pathways News

PYC Therapeutics has escalated dosing to the highest level in its Phase 1a trial of PYC-003 and begun dosing patients with Polycystic Kidney Disease, marking key progress toward regulatory milestones.

Immutep has received encouraging feedback from the FDA on its immunotherapy eftilagimod alfa combined with KEYTRUDA for patients with low PD-L1 expression in head and neck cancer, opening potential accelerated approval pathways.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

Medallion Metals has executed a binding agreement to acquire the Forrestania Nickel Operation from IGO Limited, setting the stage for a low-capital pathway to gold and copper production at its Ravensthorpe project. The transaction targets completion and a final investment decision by late 2025.

4DMedical reports a 56% revenue surge in FY25 alongside a strategic $10 million investment from Pro Medicus, advancing its CT, VQ™ lung imaging technology towards FDA clearance.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Superior Resources Limited has expanded its copper exploration strategy to include high-grade copper-gold targets alongside porphyry prospects, while progressing the Steam Engine Gold Project towards early production within two years.

American Rare Earths Limited reports strong progress at its Halleck Creek Rare Earths Project, highlighted by exceptional sampling results, key permitting milestones, and a $15 million equity raise to fund development.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.

Bio-Gene Technology Limited has secured $2.45 million to fund critical safety studies and scale-up production of its novel insecticides Flavocide and Qcide, positioning the company for upcoming regulatory approvals and commercial partnerships.

Western Yilgarn NL has significantly expanded its bauxite portfolio with the acquisition of the Cardea projects, lifting its total JORC bauxite resources to 188 million tonnes, while also securing a promising new gold project in Western Australia’s Gascoyne region.

Admiralty Resources has obtained temporary road transport approval in Chile, enabling the shipment of up to 150,000 tonnes of iron ore concentrate from its Mariposa project. This milestone advances the project closer to full production amid ongoing regulatory progress.