Latest Regulatory Milestones News

Envirosuite has secured a key regulatory green light from FIRB for its acquisition by Ideagen, moving the proposed Scheme of Arrangement closer to shareholder approval.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Sipa Resources has secured key environmental approvals to begin drilling at its newly acquired South Australian gold projects, signaling a major step forward in its exploration plans.

Neurizon Therapeutics reveals that its lead drug candidate NUZ-001 and its metabolite effectively penetrate the blood-brain barrier and reverse pathological protein aggregation linked to ALS, marking a critical step forward in neurodegenerative disease treatment.

New World Resources Limited has had its trading suspension lifted immediately following a key announcement, reopening market access for investors.

Metal Hawk Limited has secured Aboriginal heritage approval to launch a significant reverse circulation drilling program targeting high-grade gold veins at its Leinster South Project in Western Australia.

Canadian Phosphate Limited has obtained a 10,000-tonne bulk sample permit for its Barnes deposit at the Fernie Project, marking a significant step toward establishing a domestic phosphate supply in British Columbia. Additional permits are underway, supporting the company’s growth and critical minerals strategy.

Morella Corporation has initiated a pioneering rubidium extraction study with Edith Cowan University and secured key approvals for development drilling at its Mt Edon Project, setting the stage for a maiden mineral resource estimate.

Estrella Resources has ramped up its manganese exploration at the Ira Miri Project in Timor-Leste with a more powerful diamond drill rig and a fresh supergene manganese outcrop discovery, setting the stage for an extensive drilling program.

Sumitomo Corporation's subsidiary has gained crucial Foreign Investment Review Board approval to invest in Tivan Limited's Speewah Fluorite Project, paving the way for a significant joint venture.

EVE Health Group’s subsidiary Nextract has inked a pivotal two-year agreement with TeleDocs Clinic, enabling nationwide online prescribing of its upcoming erectile dysfunction and dysmenorrhea products ahead of regulatory approval.