Latest Regulatory Decisions News

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.

Smartpay Holdings Limited posted solid FY25 financials with revenue surpassing $104 million, driven by Australian market gains and promising New Zealand pilot progress. The company is advancing its trans-Tasman payments strategy amid regulatory developments.

The Takeovers Panel has declined to investigate applications challenging Pact Group Holdings’ proposed delisting, signaling regulatory acceptance of the move. The decision clarifies the Panel’s jurisdiction and leaves the delisting process on track.

The Takeovers Panel has declined Emu NL’s request to review a prior decision, citing insufficient evidence and no compelling case of association. This regulatory setback leaves Emu NL without recourse for now.

The Acting President of the Takeovers Panel has declined an interim order to postpone FBR Limited’s upcoming Extraordinary General Meeting, keeping the scheduled vote on track.

Bounty Oil & Gas, through its joint venture operator Asset Energy, has initiated a judicial review against the refusal to vary and extend the PEP-11 offshore petroleum exploration permit. The legal challenge could reshape the future of this key Sydney Basin asset.

The Takeovers Panel has declined to investigate Keybridge Capital’s applications alleging shareholder associations and takeover law breaches, clearing the way for an upcoming board replacement vote.

Bubs Australia has reported a strong Q2 FY25 performance with a positive EBITDA turnaround and robust revenue growth, while advancing its critical FDA clinical trial in the US.

Telix Pharmaceuticals has exceeded its full-year 2024 revenue guidance, driven by strong sales of its prostate cancer diagnostic Illuccix® and strategic pipeline advancements.