Latest Regulatory Decisions News

Reef Casino Trust’s takeover bid by Iris Cairns Property faces a regulatory hurdle as Queensland’s Office of Liquor and Gaming Regulation delays suitability investigations, pushing the offer period beyond March 2026.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for PYC-003, an RNA therapy targeting Polycystic Kidney Disease. This milestone moves the drug closer to pivotal Phase 2/3 trials.

Icon Energy Limited holds steady with $294,000 cash as it awaits key regulatory decisions on ATP 855 renewal and Petroleum Lease PL-1144, facing a looming ASX suspension deadline.

St Barbara Limited reports steady progress on its Simberi Expansion Project in Papua New Guinea and Atlantic Gold Projects in Canada, despite production challenges and pending regulatory decisions. A recent A$58 million capital raise strengthens its financial position for growth.

The Takeovers Panel has accepted a further undertaking from Emu NL regarding its entitlement offer and declined to declare unacceptable circumstances, resolving regulatory concerns tied to recent corporate governance actions.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

The Takeovers Panel has declined to investigate allegations against Duxton Farms’ major shareholders regarding a complex merger and share placement, clearing the way for the company’s strategic consolidation plans.

Bod Science Limited has reported a notable profit turnaround for FY2025, driven by medicinal cannabis sales growth, while navigating a complex Deed of Company Arrangement and a proposed backdoor listing with Biortica Agrimed Limited.

Medallion Metals has successfully completed the public comment phase under the EPBC Act for its Ravensthorpe Gold Project, advancing a critical regulatory milestone with no objections received. The company aims to submit final documentation in October and expects a decision before year-end, paving the way for its sulphide development strategy.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

The Takeovers Panel has declined to conduct proceedings regarding Elanor Funds Management's concerns over disclosure in the LDR Assets takeover bid, as parties move to amend the bidder's statement.