Latest Market Exclusivity News

Dimerix secures FDA confirmation that proteinuria reduction is a valid primary endpoint for its Phase 3 ACTION3 trial, advancing its kidney disease drug DMX-200 closer to approval.

TrivarX has received $3.5 million in second-tranche placement funding, enabling advancement of its innovative Stabl-Im technology for early, non-invasive brain tumour detection. The funding supports manufacturing scale-up and regulatory preparations ahead of a planned Phase 1 clinical trial in 2026.

Opthea Limited has announced a strategic pivot to develop OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women, aiming for ASX reinstatement in 2026. The company leverages strong intellectual property and cash reserves to pursue orphan drug designation and clinical development.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Invion Limited has expanded its global rights to the Photosoft™ technology, gaining exclusive perpetual licenses across a broad range of human and animal diseases, including cancers and infectious diseases. This milestone-based deal positions Invion to accelerate clinical development and commercialisation worldwide.

Recce Pharmaceuticals has reported compelling preclinical results for its inhaled anti-infective RECCE 327, demonstrating potent activity against multidrug-resistant pneumonia bacteria in mice models.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

OMG Group has inked a five-year exclusive distribution agreement with SANDAI, a premium Japanese matcha producer, positioning itself to capture significant growth in Australia’s expanding matcha market.

Invion Limited has secured a pivotal FDA Orphan Drug Designation for its lead cancer drug INV043, bolstered its balance sheet with nearly $1.8 million in new funding, and progressed clinical trials targeting skin and anogenital cancers.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.