Latest Regulatory News

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Argenica Therapeutics has won a crucial regulatory waiver from the European Medicines Agency, removing the need for paediatric trials for its stroke drug ARG-007 and clearing the way for faster adult market approval in Europe.

Recce Pharmaceuticals has secured a second Cooperative Research and Development Agreement with the U.S. Army Institute of Surgical Research to test its RECCE 327 Gel in burn wound infection models, underscoring growing military interest in its synthetic anti-infectives.

Arika Resources has agreed to acquire the remaining 20% stake in its flagship Yundamindra and Kookynie gold projects, consolidating full ownership and positioning itself for accelerated exploration in Western Australia’s prolific goldfields.

Taiton Resources has completed a significant placement of nearly 12 million shares to Singapore’s GEMS Strategic Resource Fund, bolstering its capital position and signalling confidence from a reputable international investor.

Hawsons Iron Limited has secured $2.2 million through a discounted share placement, accompanied by free attaching options, to advance key studies and optimisations for its iron project in New South Wales.

Rincon Resources has secured drilling approvals for its Hasties gold-copper deposits near Telfer, aiming to expand mineralisation and update its resource estimate by the end of Q1 2026.

Memphasys Limited secures significant repeat orders from Hamad Medical Corporation, marking a pivotal expansion of its Felix™ system across the MENA region.

Nex Metals Explorations has agreed to sell its 20% interest in the Arika Joint Venture for $2.5 million cash plus shares in Arika Resources, refocusing on its Kookynie Tailings Project and new opportunities in Egypt’s Eastern Desert.

Biome Australia has partnered with Fullscript to distribute its Activated Probiotics range across Canada, complementing its existing wholesale network and marking a key step in its international growth.

Haranga Resources has converted key performance rights into shares following milestone achievements and extended the escrow period on vendor shares, while progressing drilling at its Lincoln and Ibel South gold projects.

Tempest Minerals and Capricorn Metals have agreed to extend the completion date for the Yalgoo Project sale to mid-February 2026, allowing time to finalise administrative and regulatory requirements without altering deal terms.