Latest Regulatory Pathways News

Western Australia's State Government has backed VRX Silica's land swap proposal at Muchea, unlocking access to a significantly larger high-grade silica sand resource with lower environmental impact and paving the way for downstream glass manufacturing.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Jindalee Lithium’s US subsidiary, HiTech Minerals, has partnered with environmental nonprofit RESOLVE to investigate a voluntary stewardship area around its McDermitt Lithium Project, aiming to balance responsible lithium development with conservation efforts.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

CLINUVEL Pharmaceuticals has lodged its Form 20-F with the U.S. SEC, seeking to elevate its American Depository Receipt program to a Nasdaq-listed American Depository Share, aiming to boost visibility and liquidity without raising capital.

Encounter Resources is aggressively advancing its Aileron niobium project in Western Australia with a comprehensive 70,000-metre drilling campaign and a Mining Lease application, underpinning its push toward development.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

DPM Metals has revealed a major new gold-copper porphyry discovery at its Brevene South Porphyry target adjacent to the Chelopech mine, with drill results showing broad intervals of high-grade mineralization and plans for an intensive follow-up drilling campaign.

Memphasys has inked its first exclusive commercialization agreement in South-East Asia with TMSC Vietnam, targeting the fast-growing Vietnamese IVF sector with its Felix™ sperm separation system. The two-year contract, valued at A$530,000, hinges on regulatory approval expected by August 2026.

Nexalis Therapeutics has locked in a $53 million non-dilutive funding facility with Point8 Capital, replacing its previous lender and supporting three clinical programs targeting breakthrough cancer pain, panic disorder, and treatment-resistant depression.