Latest Patient Access News

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.

Mayne Pharma’s innovative oral contraceptive NEXTSTELLIS® has secured reimbursement under Australia’s Pharmaceutical Benefits Scheme, making it significantly more affordable and broadening contraceptive options nationwide.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

Algorae Pharmaceuticals has secured an exclusive licensing agreement with Sakar Healthcare to introduce five generic oncology medicines in Australia and New Zealand, marking its first commercial foray in the region.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.

EVE Health Group has begun distributing Dyspro™, a novel cannabinoid-based treatment for dysmenorrhoea and endometriosis, through a national telehealth partnership. This launch targets a significant unmet need in women’s health with a growing global market.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Chimeric Therapeutics reported a reduced net loss of $10.43 million for FY2025, driven by cost efficiencies and strategic project reprioritisation, while making significant clinical progress in its CAR T-cell and NK cell therapy programs.

Prescient Therapeutics has completed a $3 million share placement, bolstering its clinical development programs for innovative cancer treatments including PTX-100 and novel cell therapies.