Latest Regulatory Affairs News

Neurizon Therapeutics reported a sharp rise in half-year losses to $7.28 million but marked significant progress with its lead drug NUZ-001 entering a major ALS clinical trial and securing critical regulatory designations.

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

Insurance Australia Group Limited (IAG) reported a 91.2% surge in net profit to $778 million for the half year ended December 2024, driven by robust insurance margins and higher investment income. The company also declared a 12-cent interim dividend, signaling confidence in its financial outlook.

Genesis Energy and New Zealand’s top generators are exploring extending Huntly Power Station’s life to address supply risks highlighted by winter 2024’s energy crunch.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

CLINUVEL has released preliminary data from its CUV052 study showing SCENESSE® is well tolerated in adolescent erythropoietic protoporphyria (EPP) patients, supporting a planned label extension in 2025.

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

Noxopharm has successfully completed key in vitro safety tests for its SOF-SKN™ lupus drug, paving the way for the upcoming HERACLES Phase 1 clinical trial.

Strike Resources reports steady progress on its high-grade Apurimac Iron Ore Project in Peru, alongside key developments in its Lithium Energy investment and sale agreement.

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Cambium Bio has secured a A$3 million capital raise and achieved FDA Fast Track status for its lead ophthalmology product, Elate Ocular®, setting the stage for Phase 3 trials in mid-2025.

Blue Energy Limited reports steady progress in its Sapphire Pilot gas production despite operational interruptions and ongoing environmental authority appeals, while advancing seismic exploration in the Northern Territory.