Latest Patient Access News

EBR Systems advanced its wireless cardiac pacing rollout in Q2 2026, completing 46 implants and signing 17 new purchasing contracts while shifting focus to deeper utilisation within existing accounts.

Rhythm Biosciences bolstered its financial position with a $5.2 million option underwriting while accelerating commercial adoption of its ColoSTAT® colorectal cancer test and advancing geneType™ partnerships internationally in Q4 FY26.

Emyria has expanded its Empax clinic network across four states, reporting a 210% revenue increase in FY26 and early clinical success in treatment-resistant depression.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

LTR Pharma has locked in a comprehensive commercial agreement with Strive Pharmacy, cementing its manufacturing and fulfilment infrastructure for the upcoming US launch of ROXUS®.

LTR Pharma has formalised its US commercialisation strategy by signing a definitive agreement with telehealth leader Shed, targeting at least 150,000 ROXUS units in the first year through digital men’s health platforms.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

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.