Latest Regulatory Pathways News

Chalice Mining secures independent endorsement of its Gonneville Project environmental approvals plan, reinforcing its timeline for a Final Investment Decision in the first half of 2028.

Terragen Holdings posted a slight increase in net loss to AUD 3.75 million for FY2026, while advancing key commercial trials and securing a $7 million equity raise to fuel growth.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals secured European Commission approval for DAYBU (trofinetide) to treat Rett syndrome symptoms in patients aged five and older, marking the first EU-authorised treatment for this condition.

Jade Gas Holdings has lodged its initial Plan for Development of Operations and secured approval for a substantial 502 km² production licence area, marking pivotal steps towards commercialising Mongolia’s first coal bed methane project.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

Island Pharmaceuticals has commissioned a second manufacturing run of its antiviral Galidesivir, aiming to stockpile up to 800 treatment courses by late 2026 to support rapid response to the fast-spreading Bundibugyo Ebola outbreak and biodefence efforts.

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.