Latest Regulatory Submissions News

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.

PYC Therapeutics reports substantial progress across all four of its drug development programs in Q4 2024, including key regulatory designations and clinical milestones that set the stage for pivotal trials in 2025.

Actinogen Medical accelerates recruitment in its pivotal XanaMIA Alzheimer's trial while securing a strong cash position of $22.9 million, underpinning its late-stage development and commercial readiness.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.

Memphasys Limited marks a pivotal quarter with the completion of clinical trials for its Felix™ System, strategic market expansions in Greater China and the Middle East, and a successful capital raise to fuel growth.

InhaleRx has locked in a $38.5 million funding deal with Clendon Biotech Capital, enabling expanded Phase 2 trials for its inhaled breakthrough cancer pain and panic disorder treatments. The company also filed a key international patent, positioning itself for a faster path to FDA approval.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

Nexus Minerals reports significant exploration success at its Wallbrook Gold Project with two new gold discoveries and robust assay results from a recent aircore drilling campaign. The company plans further drilling to expand these promising targets.

New Frontier Minerals has entered a strategic alliance with Austral Resources to process copper ore from its Big One Deposit, aiming to accelerate production and exploration in the Mt Isa copper belt.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.