- CEO
- David A. Stamler
- Full Time Employees
- 9
- Sector
- Healthcare
- Industry
- Medical - Pharmaceuticals
- Address
- 350 Collins Street Melbourne VIC Australia 3000
- IPO Date
- Sep 25, 2012
- Business
- Alterity Therapeutics Limited (ASX:ATH; NASDAQ:ATHE) is an Australia-based clinical-stage biotechnology company focused on developing disease-modifying therapies for neurodegenerative diseases, particularly Parkinsonian disorders including Multiple System Atrophy (MSA) and Parkinson's disease (PD). Founded in 1997 and headquartered in Melbourne, the company develops small molecule drug candidates that inhibit the aggregation of pathological proteins such as alpha-synuclein and redistribute excess brain iron to reduce oxidative stress and preserve neurons; its lead candidate ATH434, an oral small molecule, targets these mechanisms and has Orphan Drug designation from the U.S. FDA and European Commission for MSA treatment, entitling it to market exclusivity periods of seven years in the U.S. and ten years in the EU along with development incentives. ATH434 is currently in Phase 2 clinical trials ATH434-201 (randomized, double-blind, placebo-controlled study in early-stage MSA; NCT05109091) and ATH434-202 (open-label biomarker study in advanced MSA; NCT05864365), with topline results from both trials released in 2025 demonstrating clinically meaningful benefits, favorable safety profiles, and target engagement on biomarkers like brain iron and alpha-synuclein; the company maintains an active drug discovery program generating additional patentable compounds for various neurodegenerative diseases and conducts nonclinical studies in PD models, including collaborations with Vanderbilt University Medical Center, the Florey Institute of Neuroscience, and a Michael J. Fox Foundation-funded primate study. In 2025, Alterity Therapeutics received U.S. FDA Fast Track Designation for ATH434 in MSA, completed last patient visits in the ATH434-202 trial, announced positive Phase 2 results highlighting robust clinical efficacy in January, secured A$20.0 million in strategic placement funding in September anchored by an international healthcare fund to advance regulatory discussions with the FDA and pursue partnerships without warrants or options, raised additional A$40.0 million in February to accelerate ATH434 development and research, and presented multiple oral and poster data at the International MSA Congress while conducting the bioMUSE natural history study in MSA with Vanderbilt to optimize trial designs and biomarkers. The company operates primarily in Australia with global clinical trial sites and targets patients with orphan and high-unmet-need neurodegenerative conditions lacking approved disease-modifying treatments.