Latest Regulatory Filings News

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

5E Advanced Materials has filed a Post-Effective Amendment to its SEC registration, updating the legal opinion on its planned issuance of up to 18 million shares. This move clears a key regulatory step in the company’s capital raising journey.

5E Advanced Materials has filed an SEC amendment to increase its public offering by $6 million, signalling a strategic move to bolster its capital base.

Energy Transition Minerals signals the end of its strategic partnership with Shenghe, seeking ASX approval to lapse the Top-Up Right tied to their 2016 agreement. This marks a pivotal change as ETM diversifies beyond its Greenland rare earths project.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

CurveBeam AI reported steady device orders alongside a $4 million milestone payment from its China commercialisation deal, while progressing FDA clearance and robotic surgery system validation.

5E Advanced Materials has filed a Form S-1 registration with the SEC to raise up to $30 million through a common stock offering, aiming to advance its Fort Cady boron and lithium project. The capital raise is critical as the company navigates development milestones and financial challenges.

Algorae Pharmaceuticals has advanced its AI drug discovery capabilities with the launch of AlgoraeOS v2 and secured key commercial partnerships, including a $3 million debt facility to support expansion in Australia and New Zealand.

Euro Manganese has confirmed no material changes in its operations amid recent spikes in market activity, reassuring investors and regulators alike.

Australian Strategic Materials and Energy Fuels are set to discuss their proposed acquisition in a joint webcast, offering investors a closer look at this strategic move.

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.