Latest Patient Access News

NeuroScientific Biopharmaceuticals has appointed Nathan Smith as CEO, leveraging his deep cell therapy expertise to accelerate clinical development and commercialisation of its StemSmart technology.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart technology, reporting promising clinical results in Crohn’s disease and GVHD, alongside a $3.5 million capital raise to fuel next-stage development.

EVE Health Group has secured regulatory approval enabling prescription access for its lead products Libbo and Dyspro in Australia, setting the stage for a commercial rollout before the end of 2025.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

Prescient Therapeutics has initiated its first US clinical site for the PTX-100 Phase 2a trial targeting Cutaneous T-Cell Lymphoma, marking a key milestone in expanding patient recruitment beyond Australia.

EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

BCAL Diagnostics has secured a strategic partnership with Cancer Care Associates to fast-track the clinical adoption and revenue generation of its innovative BREASTEST plus™ breast cancer blood test starting FY2026.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

Prescient Therapeutics has launched a $7 million Share Purchase Plan at a notable discount to fund the next phase of clinical trials for its promising PTX-100 cancer therapy. The capital raise aims to accelerate progress toward regulatory approval and patient access.

ECS Botanics has launched the globally acclaimed Terphogz™ cannabis strains, including The Original Z™, into the Australian medicinal market, marking a strategic expansion of its premium product portfolio.