Latest Regulatory Review News

Cyclopharm Limited has secured the maximum five-year U.S. patent extension for its flagship Technegas® Kit, extending market exclusivity to 2031 and reinforcing its strategic foothold in pulmonary imaging.

Firebrick Pharma has published its pivotal Phase 3 trial results for Nasodine nasal spray, confirming its effectiveness and safety in treating the common cold, especially when used early.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

Chorus Limited’s 2024 fibre regulatory report reveals a stable $5.9 billion asset base and revenue close to the maximum allowed, with a $153.5 million wash-up balance carried forward.

The Australian Competition and Consumer Commission has resumed its review of DP World Australia's proposed acquisition of Silk Logistics, setting a new decision deadline that extends beyond key transaction milestones.

The ACCC has decided not to oppose Insurance Australia Group’s proposed acquisition of RACQ Insurance, finding that competition in Queensland’s motor and home contents insurance markets remains robust despite the deal.

DMC Mining confirms its exploration permits in Guinea remain unaffected amid a government crackdown on non-compliant mining licences. The company welcomes regulatory reforms aimed at boosting investor confidence and is poised to start exploration once permits are granted.

Tivan Limited and Sumitomo Corporation have formalised a joint venture to develop the Speewah Fluorite Project in Western Australia, marking a major step toward establishing Australia’s inaugural fluorite mining and processing operation.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

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.

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

Clime Investment Management has been appointed lead manager for a significant US public offer fund by Sphinx Investments, with initial allocations of $183 million AUD pending SEC approval. The move marks a strategic expansion into the US market, complemented by new wholesale offerings and a partnership with a Dallas-based equities manager.