Latest Regulatory Process News

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.

Savannah Goldfields is advancing steadily towards resuming gold production at its Georgetown plant, with environmental approvals secured and operational preparations underway for an October restart.

Rapid Critical Metals Limited has requested an immediate suspension of its ASX securities to finalize a significant capital raising, with trading expected to resume upon announcement or by 17 September.

Renergen Limited and ASP Isotopes Inc. have proactively extended the deadline to fulfill outstanding conditions for their Scheme of Arrangement offer to 28 November 2025, following key regulatory approvals and ongoing collaboration.

Northern Star Resources reaffirms its Ore Reserves and Mineral Resources as of March 2025, maintaining steady production targets and a robust balance sheet while advancing key growth projects including the KCGM Mill Expansion and the Hemi Development Project.

Nordic Resources has identified compelling new exploration targets at its Kopsa Gold-Copper Project in Finland through a detailed ground magnetic survey, with drilling underway to test these promising zones.

The Mongolian government has officially endorsed a key highway project under a public-private partnership, aligning with Aspire Mining’s infrastructure plans and significantly de-risking its Ovoot Coking Coal development.

Elanor Commercial Property Fund has lodged an application with the Takeovers Panel, alleging significant disclosure deficiencies in Lederer’s off-market takeover bid and seeking a replacement bidder’s statement.

Mantle Minerals has announced a proposed capital return of $0.001 per share, subject to shareholder approval at its upcoming AGM, potentially distributing over $6 million back to investors.

Atlas Arteria reported a statutory net profit of $73.3 million for H1 2025, impacted by a new tax, while toll revenues rose 8.1%. The company reaffirmed its 2025 distribution guidance of 40 cents per security, supported by strong free cash flow growth.

Estrella Resources and its partner PT Raka Energi Mandiri have agreed to extend key project milestones for their Werumata limestone venture in Timor-Leste, reflecting internal delays but maintaining a positive outlook.

Zip Co Limited’s FY25 results reveal a powerful US market expansion driving a 147% rise in cash earnings and a strategic Nasdaq dual listing consideration.