Latest Clinical Trials News

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

VGI Partners Global Investments Limited reported a $17.6 million net loss for FY25 but maintained its dividend policy and executed a $73 million share buy-back, signaling confidence amid market challenges.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.

Opthea Limited has terminated its sozinibercept wet AMD program following Phase 3 trial failures and settled a major funding agreement, setting the stage for a strategic reset.

AdAlta Limited outlines its innovative 'East to West' cellular immunotherapy approach, in-licensing Asian CAR-T assets and progressing clinical trials in Australia to unlock value. The company also seeks partners for its anti-fibrotic and anti-malarial protein therapeutics.

Opthea has successfully settled its Development Funding Agreement, avoiding a potential $680 million liability and securing $20 million in cash. Leadership changes include the CEO and CFO stepping down, with the Chairman assuming CEO duties.

Regal Asian Investments Limited posted a sharp 92% decline in net profit for FY25 amid volatile Asian markets but maintained a fully franked 6 cent dividend and continued its on-market share buy-back program.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

Nyrada Inc has responded to ASX inquiries confirming the timely and compliant disclosure of positive safety data from its Phase I clinical trial of Xolatryp. The company detailed the timeline of its awareness and release of information, affirming adherence to continuous disclosure rules.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.