Latest Regulatory Submissions News

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Arafura Rare Earths has marked a pivotal quarter with a A$200 million cornerstone equity commitment for its Nolans Project, alongside binding offtake agreements securing two-thirds of its NdPr oxide target amid rising rare earth demand and geopolitical tensions.

Bio-Gene Technology Limited has been awarded two significant grants totaling A$3 million by the US Department of Defense, validating its innovative insecticide technologies Flavocide® and Qcide®. The company is advancing regulatory filings and scaling production to target both military and civilian markets.

Antipa Minerals has consolidated its Paterson Province tenements into the expansive Minyari Project, resumed full ownership of Wilki and Paterson Projects following partner withdrawals, and launched a major drilling campaign targeting resource growth and new discoveries.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

Magnetite Mines has submitted a key Mining Lease Proposal for its Razorback Iron Ore Project and is progressing strategic funding agreements, including a $7 million convertible note facility. The company also filed a provisional patent for a novel saline water processing method, underscoring its technical innovation in green iron production.

Zelira Therapeutics has received a $1.15 million cash refund from the Australian Government’s R&D Tax Incentive Scheme, bolstering its working capital to advance clinical development and business operations.

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.

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.

BlinkLab has secured North Shore Pediatric Therapy as the second US clinical site in its autism diagnostic study, enhancing recruitment and data quality with a leading Chicago-based specialist.

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.

Bio-Gene Technology Limited has secured A$3 million in U.S. Department of Defense grants to accelerate development of its two nature-derived insecticides, Flavocide and Qcide, targeting both military and civilian markets.