Latest Regulatory Milestones News

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

Jindalee Lithium has secured US Bureau of Land Management approval for its McDermitt Lithium Project’s Exploration Plan, paving the way for expanded drilling and advancing the project towards a feasibility study.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

Star Minerals has received mining approval for its Tumblegum South Gold Project, setting the stage for mining to commence in early 2026. With robust production targets and a key partnership in place, the project is poised to advance swiftly.

Memphasys Limited has restructured its leadership by eliminating the CEO role to back a direct-selling global commercialisation strategy for its Felix™ System, anticipating imminent CE Mark approval to enter the European IVF market.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

Terrain Minerals has completed a $1.42 million placement in December, topping up an earlier October raise to fully fund its upcoming drilling campaigns and maiden JORC resource estimate.

Beetaloo Energy has received a groundbreaking approval from the Northern Territory Government, enabling pilot gas production and sales from EP187 and advancing construction of the Carpentaria Gas Plant.