Latest Patient Access News

CLINUVEL Pharmaceuticals secures Canadian marketing approval for SCENESSE®, expanding access to the only approved systemic photoprotective treatment for erythropoietic protoporphyria (EPP).

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Racura Oncology has secured Bellberry HREC approval for its HARNESS-1 lung cancer trial, enabling expansion to additional Australian sites including Chris O’Brien Lifehouse and Austin Health, setting the stage for accelerated patient enrolment.

Emyria’s new treatment-resistant depression program shows statistically significant symptom improvements in a small initial cohort, expanding its mental health therapy offerings beyond PTSD.

Green Cross Health Limited reported a 28% rise in net profit to NZD 20.4 million for FY26, driven by gains in both pharmacy and medical divisions. The company announced a conditional sale of its Medical division to Tend Health for NZD 270 million, aiming to refocus on its core pharmacy business.

Emyria Limited is progressing its national network of psychedelic-assisted therapy clinics, reporting durable patient outcomes, expanding funding sources, and benefiting from regulatory changes that broaden therapist eligibility.

LTR Pharma has locked in Strive Specialties as its exclusive US pharmacy fulfilment partner for ROXUS, marking a critical step towards commercial launch in the US erectile dysfunction market.

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.

ImpediMed has revamped its leadership with two new commercial roles and reported encouraging sales momentum for its SOZO device. The company is advancing clinical trials and expanding its presence in cancer survivorship, weight management, and heart health sectors.

The Therapeutic Goods Administration has broadened the range of clinicians eligible to participate in psychedelic-assisted psychotherapy, a move set to speed up recruitment and improve patient access across Emyria’s national Empax network.