Latest Regulation News

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

DevEx Resources is gearing up for a major uranium drilling campaign in 2026 after expanding its Northern Territory footprint and securing nearly $39 million in fresh capital. Soil anomalies at Murphy West and strategic licence acquisitions set the stage for exploration in the McArthur Basin.

Sentinel Metals is poised to launch its maiden drilling campaign at the Columbia Gold-Silver Project in Montana, pending final regulatory approval. The company also bolsters its local engagement with a strategic executive hire and advances environmental studies.

Generation Development Group’s subsidiary Generation Life Limited has swiftly contained a cyber incident involving unauthorised access through a third-party provider, with no evidence of impact on core systems or unauthorised transactions.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Harvest Technology Group sharpened its international defence focus in Q1 2026, onboarding NATO and commercial clients to its Nodestream platform, progressing new video features, and appointing Jeff Sengelman as Executive Chair amid CEO transition.

Dalaroo Metals has completed a major soil sampling phase at its Gold Ridge Prospect in Côte d’Ivoire, submitting over 2,200 samples for assay and moving into the next phase of exploration ahead of its first drilling campaign.

Stakk Ltd (ASX: SKK) has delivered a striking 272% jump in gross receipts to $5.36 million in Q3 FY26, reversing prior cash outflows with a positive net cash flow of $2.25 million and closing the quarter with $17.34 million in cash.

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.

Kinetiko Energy has unveiled a staged gas production strategy in South Africa, aiming for initial compressed natural gas revenues by Q2/Q3 2027. The company’s new Rolling Cluster Development Strategy promises a risk-managed, capital-efficient pathway from early CNG production to full-field LNG.

Ainsworth Game Technology’s FY25 results reveal a mixed bag: a 9% dip in underlying profit to $21.1 million, a hefty $43.1 million goodwill impairment tied to North America, and a strategic pivot with a new acting CEO. Strong Asia Pacific growth and new product launches contrast with margin pressures and a shrinking cash position.

The Geological Survey of Sweden has proposed designating Aura Energy’s Häggån polymetallic deposit as a national interest, potentially securing legal protections that support Europe’s clean energy ambitions through critical minerals like uranium and vanadium.