Alterity Therapeutics Ltd Stock Price, News & Analysis

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.

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.