Latest Patient Access News

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

AdAlta, Oribiotech, and Cell Therapies have inked a Memorandum of Understanding to deploy Oribiotech’s IRO automated cell therapy manufacturing platform in Australia and Asia Pacific, aiming to slash costs and boost production speed for CAR-T therapies.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Vitura Health has appointed Justin James as its new CEO, bringing a wealth of healthcare leadership and a proven track record in specialty therapies to accelerate the company’s transformation.

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

BCAL Diagnostics is expanding access to its Avantect pancreatic and ovarian cancer blood tests across Australia through partnerships with major pathology providers. This move marks a significant step in making early cancer detection more widely available.

Emyria Limited is on track to open its first Empax clinic in Victoria by Q2 2026, having secured key operational milestones including a trained clinical workforce and dual reimbursement pathways.

CLINUVEL Pharmaceuticals reports record first-half profits and confirms CEO Philippe Wolgen’s leadership through a pivotal growth phase, prioritising its vitiligo program and Nasdaq ambitions.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.