Latest Regulatory Process News

Infinity Metals reports progress on its San Jose lithium mining license application in Spain while facing drilling delays and strategic shifts in its Australian gold-copper projects.

Actinogen Medical has fast-tracked enrolment in its pivotal Alzheimer’s trial, secured a clear FDA regulatory path, and strengthened its financial position with funding extending its runway to mid-2026.

Resolution Minerals is fast-tracking its downstream antimony strategy in Idaho, aiming to become a key US supplier while preparing for a Nasdaq listing with Tribeca Capital's support.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

Sarytogan Graphite Limited has obtained a US$2.2 million loan advance from a related party investor to accelerate its Definitive Feasibility Study on the strategically important Sarytogan Graphite Project in Kazakhstan.

Prominence Energy has extended its agreement to acquire the Gawler Hydrogen Project, allowing more time to secure final regulatory approvals and advance exploration in South Australia.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Health Canada has requested additional information, extending its review of CLINUVEL’s SCENESSE® for erythropoietic protoporphyria (EPP) into 2026. Meanwhile, Canadian patients continue to access the treatment via a Special Access Program.

NSX Limited shareholders have overwhelmingly approved a scheme of arrangement for acquisition by a CNSX Markets-related entity, setting the stage for a significant market transition pending court approval.

Dundas Minerals has raised $1.1 million through a discounted share placement to fund ongoing gold exploration in Western Australia, alongside appointing a new Company Secretary to strengthen corporate governance.

Ballard Mining has achieved a critical milestone with full permitting for its Mt Ida Gold Project, including approval to build a 2.0 million tonnes per annum processing plant and tailings facility. This final green light positions the project for development and potential expansion.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.