Latest Clinical Trials News

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.

Island Pharmaceuticals has completed dosing in the Phase 2b cohort of its dengue fever trial, with pharmacokinetic targets met and top-line results expected next month. The company also strengthened its balance sheet by raising $1.94 million through option exercises.

Tryptamine Therapeutics has secured a landmark agreement with Swinburne University to initiate the first clinical trial of its IV-infused psilocin formulation TRP-8803 for Binge Eating Disorder, aiming to build on promising Phase 2a data.

Amplia Therapeutics has completed recruitment early for its Phase 2a ACCENT trial in advanced pancreatic cancer, reporting encouraging interim results and advancing a second trial with FDA-backed protocol changes.

Ecofibre Limited reported a $2.2 million operating cash outflow in 3Q25 with total cash at $1.3 million, highlighting mixed progress across its business units and a pressing need to monetise assets to sustain operations.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

Opyl Limited reports strong progress in AI-driven clinical trial optimisation with active commercial initiatives, strategic partnerships, and a planned capital raise to support growth amid tight cash reserves.

OncoSil Medical has reported a remarkable 233% increase in dose sales for Q3 FY25, alongside significant regulatory approvals and strategic expansions that position the company for accelerated growth.

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

Zelira Therapeutics has enhanced its financial flexibility through a $1.15 million R&D tax refund and a $1 million At-the-Market equity facility, while progressing FDA trial preparations for its HOPE® 1 autism treatment.