Latest Regulatory Pathways News

ADX Energy has lodged applications for two offshore gas exploration permits adjacent to its existing Sicily Channel licence, aiming to extend its footprint in a geologically promising biogenic gas play.

Coda Minerals is set to begin a focused reverse circulation drilling program at its Oakden prospect, aiming to validate historical shallow copper mineralisation and assess its potential as early mill feed for the Elizabeth Creek project.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

EVE Health Group has progressed its Libbo pilot clinical study for erectile dysfunction with dosing set for Q4 2026 and achieved a major solubility breakthrough for apixaban, while appointing Ben Rohr as CEO to drive commercial growth.

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Acrux Limited spotlighted its Female Testosterone Metered Dose Transdermal System (MDTS) at the Bioshares Biotech Summit, revealing positive Phase II data and outlining a clear regulatory and commercial roadmap targeting Hypoactive Sexual Desire Disorder (HSDD) in women.

OD6 Metals has completed its acquisition of the Quinn Fluorspar Project, consolidating 100% ownership of 226 mining claims in Nevada and positioning itself as a potential key domestic fluorspar supplier for the US.

Medallion Metals has wrapped up all key regulatory hurdles for its Ravensthorpe Gold Project, clearing the way for mine development and early production activities to begin this year.

Equus Energy has completed a critical Pre-FEED study for its Equus Gas Project, confirming two cost-effective development pathways and initiating commercial partnerships. The company also strengthened its board and maintains a solid cash position heading into FEED.