Latest Market Exclusivity News

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.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Zelira Therapeutics reported a significantly reduced loss of AUD 3.85 million for FY25, driven by clinical progress and strategic funding for its HOPE® cannabinoid medicines. The company also expanded its patent portfolio and commercial footprint across key markets.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

Mesoblast Limited marked a transformative year with FDA approval and commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, driving a 191% jump in cell therapy revenues. The company is now poised to expand its footprint in inflammatory diseases with multiple clinical trials and label extensions underway.

Invion Limited has affirmed its compliance with ASX disclosure rules following the US FDA’s granting of Orphan Drug Designation for its anal cancer treatment candidate INV043. The company detailed the timing and verification process behind its announcement.

Cyclopharm Limited reported a 26% revenue increase for the half year ended June 2025, driven by rapid US market expansion and strong growth in its Third-Party distribution business. Despite a wider net loss, the company secured a key patent extension and reaffirmed its target to install 250-300 Technegas® systems in the US by late 2026.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.