Latest Regulatory Submissions News

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.

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.

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.

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.

Tissue Repair Limited reports initial patient enrolment in its pivotal Phase 3 trial for TR987®, alongside a robust 35% quarterly sales increase for its TR Pro+® product. The company is also advancing manufacturing and distribution strategies to support growth.

Opthea Limited reports steady progress in its Phase 3 trials for sozinibercept, a novel treatment for wet AMD, supported by a strong cash position and a recent R&D tax incentive.

Gibb River Diamonds secures key agreements to progress gold mining at Edjudina and gains international exposure for its Ellendale Diamond Project, positioning itself for growth across multiple mineral fronts.