Latest Clinical Studies News

The Garvan Institute has won a $3 million MRFF grant to conduct pivotal pancreatic cancer studies, including one evaluating Syntara’s amsulostat combined with chemotherapy. Recruitment is slated to begin mid-2026 across major NSW cancer centres.

Orthocell has increased its investment in Marine Biomedical to 11.7%, securing exclusive distribution rights to the innovative PearlBone™ technology as it nears FDA approval.

ReNerve Limited has secured market approval for its NervAlign® Nerve Cuff in Malaysia, marking a key milestone in its Asia-Pacific expansion strategy. This approval follows earlier clearances in Hong Kong and Thailand, positioning the company to tap into a growing regional nerve repair market.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

EBR Systems reported a doubling of WiSE System implants in Q4 FY2025 alongside the launch of key clinical studies and preliminary revenue guidance, signalling strong commercial and clinical momentum.

Neurizon Therapeutics has locked in a $44 million funding package to fully support its lead drug NUZ-001 in the HEALEY ALS Platform Trial, marking a critical step toward potential regulatory approval and broader neurodegenerative applications.

Invion Limited’s partner Hanlim Pharm, backed by South Korea’s government grant, has secured up to A$2 million in non-dilutive funding to advance preclinical studies of HL270 for oesophageal cancer, paving the way for human trials in Australia.

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.

Anatara Lifesciences reports encouraging pre-clinical results for its anti-obesity candidate AOC, demonstrating significant reductions in weight regain and visceral fat in mice. However, a delay in mechanism of action studies pushes full data release to January 2026.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.