Latest Clinical Trials News

PYC Therapeutics has completed dosing in its Phase 1 study of PYC-001 for Autosomal Dominant Optic Atrophy, showing strong safety and early signs of improved vision. The company plans to launch a global Phase 1/2 trial later this year.

Control Bionics Limited has announced a 1-for-5 non-renounceable rights issue to raise up to $2.06 million, aiming to fund the commercial expansion of its NeuroStrip® device and operational growth. The offer is partially underwritten and open to eligible shareholders in Australia and New Zealand.

Amplia Therapeutics has commenced dosing the first patient in its new pancreatic cancer trial combining narmafotinib with FOLFIRINOX chemotherapy, marking a key milestone in its drug development journey.

Argenica Therapeutics has reported positive Phase 2 trial results for ARG-007 in acute ischemic stroke patients, confirming safety and revealing a promising efficacy signal in a high-risk subgroup with slow collateral blood flow.

Biome Australia Limited projects its Q1 FY26 sales revenue to exceed $5.5 million, breaking its previous quarterly record and signaling continued momentum in the microbiome health sector.

Race Oncology has activated its first clinical trial site in Hong Kong for the Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours, marking a significant step in accelerating patient enrolment and broadening clinical data.

Biome Australia has partnered with Green Cross Health to launch its Activated Probiotics across New Zealand’s largest pharmacy network, marking a pivotal step in its international growth strategy.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

Opthea Limited reported a 26% reduction in net loss for FY2025 despite discontinuing its wet AMD drug after failed Phase III trials. The company settled its Development Funding Agreement with investors, securing liquidity and planning a strategic pivot.