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About Alterity Therapeutics Ltd (ASX: ATHE)
Alterity Therapeutics Ltd is a pioneering biotechnology company dedicated to the research and development of innovative therapeutic drugs targeting neurodegenerative diseases. Based in Melbourne, Australia, the company focuses on addressing critical unmet medical needs in conditions such as Parkinsonian disorders, Alzheimer's disease, Huntington's disease, and Multiple System Atrophy (MSA). By leveraging cutting-edge scientific research, Alterity aims to develop transformative treatments that improve the quality of life for patients worldwide.
Core Drug Candidates
Alterity's lead drug candidate, ATH434, is designed to treat Parkinsonian disorders, specifically Multiple System Atrophy (MSA). ATH434 uniquely targets the accumulation of excess iron in the brain, a key factor contributing to neurodegeneration. The drug has successfully completed Phase I clinical trials, demonstrating safety and tolerability in humans, and is now progressing through further clinical development. This innovative approach positions ATH434 as a potential breakthrough in the treatment of Parkinsonian movement disorders.
The company is also advancing PBT2, a drug candidate originally developed for Alzheimer's and Huntington's diseases. PBT2's unique mechanism of action includes its potential use as an antimicrobial agent, showcasing the company's versatility in addressing diverse medical challenges.
Research Focus and Expertise
Alterity Therapeutics operates at the forefront of neurodegenerative research, with a specialized focus on diseases characterized by protein misfolding, oxidative stress, and iron dysregulation. The company's scientific strategy emphasizes neuroprotection and disease modification, aiming to slow or halt disease progression rather than merely alleviating symptoms. This approach underscores Alterity's commitment to delivering long-term benefits to patients and healthcare systems.
Industry Context and Competitive Positioning
The biotechnology sector addressing neurodegenerative diseases is highly competitive and driven by innovation. Alterity Therapeutics differentiates itself through its targeted approach to iron dysregulation and its focus on rare and underserved conditions like MSA. While the company faces challenges such as lengthy clinical development timelines and regulatory hurdles, its strategic focus on high-impact therapeutic areas positions it as a key contender in the neurodegenerative disease space. Potential competitors include both established pharmaceutical companies and emerging biotech firms, but Alterity's unique drug mechanisms and research collaborations enhance its competitive edge.
Company History and Evolution
Founded in 1997, Alterity Therapeutics was initially known as Prana Biotechnology Limited. In 2019, the company rebranded to reflect its evolved mission and focus on altering the course of neurodegenerative diseases. This transformation underscores its commitment to innovation and its strategic pivot toward addressing complex neurological conditions.
Conclusion
Alterity Therapeutics Ltd stands at the intersection of cutting-edge science and urgent medical need. With a robust pipeline of drug candidates, a focus on groundbreaking research, and a commitment to addressing some of the most challenging neurodegenerative diseases, the company continues to make strides in its mission to transform patient outcomes. Its pioneering work in targeting iron dysregulation and its dedication to underserved conditions solidify its position as a significant player in the biotechnology landscape.
Alterity Therapeutics (NASDAQ: ATHE) announced two new preclinical studies showcasing the efficacy of ATH434 in treating Parkinsonian disorders. These studies published in the Journal of Parkinson's Disease and Plos One highlight the potential of ATH434 to alleviate gastrointestinal complications associated with Parkinson's disease by reversing colonic dysfunction and modulating iron trafficking. CEO David Stamler emphasized ATH434's promise in enhancing patient quality of life and mentioned ongoing preclinical studies aimed at advancing its clinical development.
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) provided an update on its clinical programs and financials for Q1 FY22, ending September 30, 2021. The company reported a cash balance of A$41.3M and a quarterly cash outflow of A$4.9M, consistent with ongoing clinical activities. Key highlights include advancements in the ATH434 Phase 2 trial for Multiple System Atrophy (MSA) and the expansion of its bioMUSE study, which aims to refine patient selection for therapies. Intellectual property have seen significant growth, enhancing future opportunities.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) has announced an expansion of the Phase 2 clinical trial for ATH434 targeting Multiple System Atrophy (MSA), a rare neurodegenerative disorder. The double-blind, placebo-controlled study will assess ATH434's effects on biomarkers related to α-synuclein aggregation and iron levels over 12 months across 30 sites in Australia, New Zealand, Europe, and the U.S. Additionally, the bioMUSE study will expand to 20 patients, enhancing data for the trial. ATH434 has Orphan designation and aims to improve the quality of life for MSA patients.
Alterity Therapeutics (NASDAQ: ATHE) reported progress in its biomarker study, bioMUSE, for early Multiple System Atrophy (MSA) patients. Data presented at the International Parkinson and Movement Disorder Society Congress 2021 highlighted the identification of iron accumulation in the brain as a potential biomarker for MSA. This could enhance patient selection for the upcoming Phase 2 trial of ATH434, aimed at treating MSA. The ongoing study is vital for understanding disease progression in MSA, which currently has no approved therapies.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced a Notice of Allowance from the USPTO for its patent application No. 17/239,375, securing exclusivity for a new group of iron chaperones aimed at addressing neurodegenerative diseases like Alzheimer's and Parkinson's. This patent covers over 80 novel compounds and follows the recent grant of another patent for 150 additional compounds. The company plans to advance its lead clinical asset, ATH434, into a Phase 2 trial, targeting Multiple System Atrophy and other conditions, while benefiting from approximately 20 years of patent exclusivity.
Alterity Therapeutics reported positive guidance from the European Medicines Agency for its ATH434 Phase 2 clinical trial in treating Multiple System Atrophy (MSA). During Q4 FY21, the company ended with a cash balance of A$28M, bolstered by $17M proceeds from an equity facility. An independent study published in Movement Disorders confirmed ATH434's neuroprotective effects in MSA models. The company aims to commence its clinical trial by year-end 2021, following progress in its natural history study underway at Vanderbilt University.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced study results showing that ATH434 can reduce α–synuclein related neurodegeneration in a murine model of Multiple System Atrophy (MSA). Published in Movement Disorders, the study found that ATH434 preserves neurons and enhances motor functions. The company plans to initiate a Phase 2 clinical trial by year-end. MSA, affecting about 15,000 patients in the U.S., currently has no approved therapy, making ATH434 a potential breakthrough treatment.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced the granting of a new composition of matter patent from the USPTO, covering a class of iron chaperones aimed at redistributing excess iron in the central nervous system. This patent secures a monopoly over 150 pharmaceutical compositions targeting neurodegenerative diseases such as Alzheimer's and Parkinson's. The company plans to launch a Phase 2 trial for its lead candidate, ATH434, by year-end, which is developed for Multiple System Atrophy (MSA) and is expected to advance their drug development efforts.
Alterity Therapeutics has received positive guidance from the European Medicines Agency (EMA) for its Phase 2 clinical trial of ATH434 targeting Multiple System Atrophy (MSA). The EMA supports recruiting early-stage MSA patients and the use of biomarkers to identify them. Alterity aims to utilize the EMA's feedback to improve trial design, aiming to generate robust data for regulatory authorities. The trial is set to launch in the second half of the year, focusing on a disease modifying approach as no approved treatment currently exists for MSA.
Alterity Therapeutics Limited (NASDAQ: ATHE) reported a cash balance of $32.8M for Q3 FY21, with operational cash outflows of $5M. The company received a $495K grant from the Michael J. Fox Foundation for Parkinson's disease research related to its lead drug candidate, ATH434. Progress continues on the Phase 2 trial for ATH434, with 80% of the target population recruited in a related study at Vanderbilt University. Dr David Stamler was appointed CEO, succeeding Geoffrey Kempler.
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