Latest Regulatory Decisions News

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.

The Takeovers Panel has declined to intervene in the Elanor Commercial Property Fund's takeover bid by LDR Assets, following resolution of disclosure concerns.

The Takeovers Panel has approved a key variation to betr Entertainment’s undertaking, removing shareholder approval hurdles for MIXI Australia’s participation in a selective share buy-back tied to its competing bid for PointsBet.

The Takeovers Panel has declined to intervene in PointsBet’s issuance of over 10 million new shares during a fierce takeover contest, affirming the board’s discretion amid competing bids from betr and MIXI Australia.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.