Latest Regulatory Approvals News

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Atomo Diagnostics Limited has announced a capital raising initiative comprising a Share Purchase Plan (SPP) and a Placement, aiming to raise up to $1 million through the SPP and additional funds via a Placement, subject to shareholder approval at a June 23 meeting.

Sayona Mining reports solid FY25 operational gains and outlines strategic merger progress with Piedmont Lithium, positioning itself as a leading North American lithium producer amid a recovering market.

Infinity Lithium Corporation has withdrawn from Spain’s PERTE VEC IIa capital funding program, opting to return nearly €20 million due to prolonged permitting and regulatory hurdles.

Kingston Resources has agreed to sell its Misima Gold Project to Ok Tedi Mining for $95 million, strengthening its balance sheet and enabling a strategic pivot towards expanding its Mineral Hill copper and gold operations.

Advance Metals has completed its initial drilling at the Myrtleford Project, revealing impressive high-grade gold results at Happy Valley and greenlighting an expanded follow-up program to explore extensions and new prospects along the trend.

Southern Palladium has secured Environmental Authorisation for its Bengwenyama PGM Project, a crucial step toward mining rights and project development. The company is also refining a phased, lower-capital approach to unlock value and improve financeability.

UVRE Limited is set to acquire New Zealand gold explorer Otagold Limited, issuing 75 million shares as consideration and raising $4 million to fund exploration. The move significantly broadens UVRE’s exposure to high-potential gold projects in a tier 1 mining jurisdiction.

Uvre Limited is set to acquire New Zealand gold explorer Otagold, backed by a $4 million equity raise and the appointment of mining veterans Norman Seckold and Peter Nightingale to its board.

Anatara Lifesciences has expanded its intellectual property footprint with a 20-year patent granted in Hong Kong for its GaRP gastrointestinal health product, following similar approvals in Europe and Australia. This milestone strengthens its commercial position in the lucrative global market for digestive health solutions.

Archer Materials has teamed up with UK-based Paragraf to fast-track development of its Biochip sensor for at-home chronic kidney disease testing, aiming to enhance accuracy and product readiness over six months.

Constellation Resources has unveiled promising initial results from its Edmund-Collier Natural Hydrogen Project, confirming organic-rich shales capable of generating thermogenic hydrogen. This milestone underscores the project's potential in the emerging zero-carbon hydrogen sector.