Latest Clinical Data News

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.

Biome Australia has launched a multi-centre clinical trial for its proprietary probiotic BMB18, adding a prestigious Greek university to its research network and commencing recruitment within the expected timeline.

Osteopore has secured Hainan FDA approval to clinically use and sell its custom orthopaedic devices at Shanghai Ruijin Hospital’s Hainan branch, marking a key step towards wider China market access. The company has scheduled its first patient surgery for June 2026.

Aroa Biosurgery posted a breakout FY26, beating revenue and EBITDA guidance with a 54% surge in Myriad sales. The company plans significant investments in FY27 to accelerate growth and capitalise on new market opportunities.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

OncoSil Medical’s interim OSPREY Registry data show strong safety and promising survival outcomes for its targeted radiotherapy device in unresectable locally advanced pancreatic cancer, surpassing historical benchmarks.

AVITA Medical reported a 4% revenue increase in Q1 2026 with a narrowed net loss, underpinned by a new BARDA contract and promising Cohealyx clinical data. Leadership changes and regulatory approvals support a confident outlook.

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Syntara Limited offers existing shareholders a discounted share purchase plan to raise about $2 million, following a recent $8 million institutional placement to fund clinical trials and licensing.

Vectus Biosystems appoints Dr Tara Speranza as CEO and CTO to accelerate development of lead fibrosis drug VB0004 with performance-linked incentives.

Anteris Technologies has treated the first US patients in its global PARADIGM trial, marking a key milestone in testing its DurAVR transcatheter heart valve against established devices.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.