Welcome to our dedicated page for Alterity Therapeutics news (Ticker: ATHE), a resource for investors and traders seeking the latest updates and insights on Alterity Therapeutics stock.
News and updates for Alterity Therapeutics Limited (ATHE) center on its progress as a clinical stage biotechnology company developing disease modifying treatments for neurodegenerative diseases. The company’s announcements emphasize its initial focus on Parkinson’s disease and related disorders, particularly Multiple System Atrophy (MSA), and the development of its lead oral agent ATH434.
Investors and followers of ATHE can expect regular news about clinical trial milestones and data presentations. Alterity has reported positive results from its ATH434‑201 randomized, double‑blind, placebo‑controlled Phase 2 trial in MSA, as well as topline data from the ATH434‑202 open‑label Phase 2 trial in more advanced MSA. Company news often highlights analyses of UMSARS Part I activities of daily living scores, orthostatic hypotension symptom assessments, wearable sensor data, and neuroimaging and biomarker endpoints such as brain iron and the MSA Atrophy Index.
Alterity’s news flow also includes regulatory and designation updates, such as Fast Track Designation by the U.S. Food and Drug Administration and Orphan Drug Designation by the FDA and European Commission for ATH434 in MSA. Additional items cover participation in major neurology and movement disorder conferences, where the company presents new analyses, biomarker findings, and natural history study results, as well as appearances at healthcare and biotech investor events.
On this page, readers can follow announcements about capital raises, quarterly cash flow reports, and corporate presentations that describe Alterity’s cash position, development plans, and engagement with regulators. For those tracking ATHE, the news stream provides context on how the company is advancing ATH434 in MSA, refining its biomarker strategy, and interacting with the scientific and investment communities over time.
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.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced an oral presentation at the American Academy of Neurology conference on April 21, 2021, regarding its lead compound ATH434, aimed at treating Parkinsonian disorders. The presentation showed that ATH434 is neuroprotective, preserving neurons in critical brain regions and improving motor function in an animal model of Multiple System Atrophy (MSA). The findings provide further evidence of ATH434's potential as a disease-modifying treatment, supported by data showing reductions in toxic α-synuclein levels and improved coordination.
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) will present at the 7th International Congress of Multiple System Atrophy (MSA2021) on February 26-27, 2021. This premier virtual event focuses on MSA, a severe neurodegenerative disease without an approved treatment. Alterity will showcase data on ATH434, its lead candidate, highlighting its safety profile concerning blood pressure regulation—a critical factor in MSA. The company is also conducting a natural history study in partnership with Vanderbilt University to support future treatment studies.
Alterity Therapeutics (NASDAQ: ATHE) announced a grant of US$495,000 from The Michael J. Fox Foundation for Parkinson's Research on February 9, 2021. This funding aims to evaluate the pharmacologic profile of ATH434, targeting optimal dosing in future clinical trials for Parkinson's disease. This marks the second grant from the Foundation to support ATH434's development. ATH434 aims to modify alpha-synuclein misfolding, which could impact symptoms of Parkinson's disease and related disorders. The project will utilize primate models to determine dosing in upcoming trials.
Alterity Therapeutics announced the appointment of Dr. David Stamler as CEO, effective immediately. Dr. Stamler, who joined the company in June 2017, has extensive experience in pharmaceutical development, specifically in neurological treatments. He succeeds Geoffrey Kempler, who will transition to Non-Executive Chairman and remain as a consultant. This leadership change coincides with the advancement of Alterity's lead compound, ATH434, into Phase 2 clinical trials. ATH434 has been granted Orphan designation by the US FDA for treating Multiple System Atrophy.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) has secured an exclusive license from UniQuest to develop novel zinc ionophore technology aimed at fighting antimicrobial resistance to superbugs. This technology, which utilizes Alterity's PBT2, allows for the re-sensitization of bacteria to antibiotics, addressing a critical health issue. PBT2 has shown potential in reversing antibiotic resistance in preclinical studies and is patented until 2038. The partnership with UniQuest may significantly enhance Alterity's commercial prospects while maintaining focus on its primary program for ATH434.
Alterity Therapeutics (ATHE) announced the allowance of a new patent by the USPTO, covering over 150 novel compounds aimed at treating neurodegenerative diseases such as Parkinson's and Alzheimer's. This patent grants 20 years of exclusivity, bolstering the company's drug development portfolio. Alterity's lead candidate, ATH434, shows promise in clinical development, demonstrating favorable safety and efficacy in animal models. CEO Geoffrey Kempler emphasized the significance of this patent in pursuing innovative therapeutic options for serious brain diseases.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced the start of patient enrollment for its bioMUSE Study focusing on Multiple System Atrophy (MSA) on Oct. 26, 2020. The study, conducted in collaboration with Vanderbilt University Medical Center, aims to track disease progression in early-stage MSA patients. The bioMUSE study data will inform the upcoming Phase 2 clinical trial of Alterity's lead compound, ATH434, which has completed Phase 1 trials. MSA is a debilitating neurodegenerative condition with no approved therapies, making this study crucial for advancing treatment options.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced new clinical data for its drug candidate ATH434, which will be presented at the 2020 International Congress of Parkinson's Disease and Movement Disorders and the American Neurological Association's Annual Meeting. New animal data confirms ATH434's effectiveness in reducing α-synuclein pathology and preserving neurons in a Multiple System Atrophy model. Additionally, new safety data indicates ATH434 has no significant cardiac liability, supporting its advancement to Phase 2 development after FDA discussions.