Latest Regulatory Developments News

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Yancoal Australia posted a record 38.6 million tonnes of attributable saleable coal in 2025, up 5% on 2024, but net profit after tax plunged 64% to A$440 million amid softer coal prices. The miner maintained disciplined cost control and declared A$769 million in fully franked dividends.

Sequoia Financial Group has provided an update on the proposed sale of InterPrac Financial Planning to Conquest Investment Partners, highlighting ASIC’s court action seeking receiver appointment over certain guarantees and ongoing discussions with ASX regarding shareholder approval.

TMK Energy Limited (ASX: TMK) reported a 48% increase in average daily gas production at its Gurvantes XXXV Coal Seam Gas Project in March 2026, achieving a new peak daily rate before temporarily curtailing output for operational safety. The company also secured a Memorandum of Understanding with Mongolia’s regulator to facilitate power generation and progress towards an exploitation license.

Vmoto Limited forecasts FY26 sales revenue between $73.5 million and $85 million, marking a 57% to 82% increase over FY25, driven by growing orders, strategic partnerships, and regulatory trends favouring electric motorcycles in key markets.

Identitii Limited has secured $200,000 through a placement of approximately 28.57 million shares at $0.007 each to existing shareholders, including Cameron Beavis, to address short-term funding needs while adhering to Takeovers Panel orders related to its Rights Issue.

Xenitra Limited (ASX:XEN) has introduced the OPAL Token and Xen Shop, a blockchain-based digital commerce ecosystem aimed at improving product authentication, customer loyalty, and sales transparency across its Asian FMCG markets.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Fiducian Group Limited has responded to a sharp share price drop by denying any undisclosed information and downplaying the impact of new APRA licence conditions on its operations.

PEXA Group has dismissed any undisclosed information behind its recent share price drop, attributing market moves to a preliminary IPART pricing consultation paper.

Lumos Diagnostics has secured its largest-ever order for FebriDx® following FDA clearance, signalling a major expansion in the US market opportunity.

The High Court of Asturias has upheld a municipal council's procedural ruling against EMC Gold’s urban plan amendment for the Salave Gold Project, leaving the project’s technical merits untouched. EMC Gold signals ongoing stakeholder engagement and alternative development strategies ahead.