Latest Regulatory Progress News

Memphasys Limited (ASX: MEM) announced an investor webinar and released an updated presentation detailing its transition from early-stage commercialisation to scaling global revenues, highlighting multi-market sales, recurring cartridge revenue, and regulatory progress.

Capricorn Metals delivered 30,358 ounces of gold in Q3 FY26 at the Karlawinda Gold Project, aligning with its mine plan and progressing the Karlawinda Expansion Project with peak construction activity.

Algorae Pharmaceuticals has reached a key regulatory milestone as the TGA accepts its initial registration dossier, paving the way for potential commercialisation of its generic medicines in Australia and New Zealand.

Infini Resources has finalised drill targets for a maiden 2,500m diamond drilling campaign at its Reynolds Lake and Reitenbach Lake uranium projects, aiming to unlock the potential of a large, underexplored uranium system on the eastern margin of the Athabasca Basin.

Papua New Guinea’s Conservation and Environment Protection Authority has approved an updated Environment Permit for Geopacific Resources’ Woodlark Gold Project, enabling increased throughput and signalling strong government backing ahead of a key feasibility study.

Alterity Therapeutics has secured encouraging regulatory feedback from the FDA on its ATH434 Phase 3 program for Multiple System Atrophy, marking a critical step towards pivotal trial initiation.

Native Mineral Resources has successfully poured 560 ounces of gold doré at its Blackjack plant and is on track to begin mining at Podosky in April, advancing multiple projects in Queensland.

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.

Eve Health Group is advancing its proprietary reformulation platform with two fast-onset products launched under Australia's SAS-B pathway, targeting large underserved markets in women's and men's health. The company’s capital-light, partner-led model aims for rapid revenue growth post-ARTG registration.

Greenwing Resources has launched a Pre-Feasibility Study to refine its plan for restarting mining at Que River, Tasmania, while exploring a novel data infrastructure opportunity on site.

Sentinel Metals has reached a pivotal regulatory milestone as its Columbia Gold-Silver Project’s exploration amendment enters the public comment phase, paving the way for maiden drilling expected in April 2026.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.