Latest Regulatory Filings News

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Activeport Group Ltd has revised the timetable for its pro-rata bonus issue of unquoted options, outlining key dates and eligible shareholders across multiple countries.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

Anteris Technologies Global Corp. has filed a Form S-1 registration statement with the SEC to enable resale of shares issued in a recent private placement, marking a key step in advancing its DurAVR transcatheter heart valve system and pivotal clinical trials.

BHP Group has officially ended talks to combine with Anglo American, choosing instead to focus on its own growth strategy. The mining giant acknowledges the strategic benefits of a merger but remains confident in its independent path forward.

Embark Early Education has revised the timeline for its conditional takeover bid of Mayfield Childcare, delaying key regulatory filings into early 2026.

5E Advanced Materials reports progress on its California boron project with a new feasibility study and equity raises, while highlighting ongoing funding uncertainties.

The Supreme Court of Western Australia has approved the share and option schemes for Capricorn Metals’ acquisition of Warriedar Resources, setting the stage for a significant consolidation in the gold exploration sector.

Mt Malcolm Mines NL has suspended trading of its M2MOA securities pending regulatory compliance, signaling a cautious pause for investors.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.