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Tag: NASD:ATHE

  • Alterity (ATHE) Sees Major Stock Rally After Clinical Success

    Alterity (ATHE) Sees Major Stock Rally After Clinical Success

    Following the release of encouraging clinical trial data, Alterity Therapeutics Limited (NASDAQ: ATHE) stock value has significantly increased. ATHE shares have risen 47.42% to $4.29 as of the most recent market check.

    Alterity Unveiled Breakthrough in MSA Treatment

    The ATH434-201 Phase 2 clinical trial, a randomized, double-blind, placebo-controlled study evaluating ATH434 in individuals with early-stage multiple system atrophy (MSA), provided Alterity (ATHE) with promising topline findings.

    A key instrument for assessing disability in daily activities impacted by MSA, the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I, was found to be significantly improved by ATH434 in both clinical and statistical analyses. After 52 weeks, the drug postponed clinical development by 29% at the 75 mg level and 48% at the 50 mg dose as compared to a placebo.

    Biomarker and MRI Evidence Support Drug Efficacy

    In this uncommon, fast-progressing illness, ATH434 has shown a notable slowdown of clinical development along with an exceptional safety profile. These findings suggest that ATH434’s targeted iron engagement may really have a disease-modifying impact, considering there are currently no authorized medications that delay the course of MSA.

    ATHE On Pathway Toward FDA Engagement

    With no currently approved treatments capable of slowing MSA progression, these findings suggest that ATH434 may offer a transformative disease-modifying effect. Alterity Therapeutics has confirmed its intent to engage with the U.S. Food and Drug Administration (FDA) to accelerate development plans based on these promising results.

    This breakthrough has implications for developing disease-modifying treatments for both orphan diseases like MSA and major neurodegenerative disorders, offering new hope for patients facing these debilitating conditions.

    Market Performance and Analyst Ratings

    Following these promising clinical trial results, Alterity Therapeutics has garnered increased attention from analysts and investors. ATHE stock has an ST score of 43 on our screener, with analysts assigning a Strong Buy rating. Investors seeking insights into comparable biotechnology stocks can explore our screener link for further analysis.

  • Alterity (ATHE) Stock Gains Momentum With Key Clinical Trial Update

    Alterity (ATHE) Stock Gains Momentum With Key Clinical Trial Update

    As of the most recent check, Alterity Therapeutics Limited’s (NASDAQ: ATHE) stock was up 36.09%, trading at $2.17 on the US stock charts. The news of a significant success in its ATH434-201 Phase 2 clinical study triggered the spike in ATHE shares. This milestone marks the completion of clinical evaluations for the last enrolled patient, propelling the company closer to revealing its topline results, anticipated in late January or early February 2025.

    Trial Goals and Overview

    To evaluate the safety and efficacy of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurological condition, a randomized, double-blind, placebo-controlled study known as the ATH434-201 Phase 2 trial was developed. Alterity was aiming assessing the impact of the drug on neuroimaging and protein biomarkers, such as aggregating α-synuclein and brain iron, which are significant in MSA pathogenesis.

    Additionally, clinical endpoints, safety, pharmacokinetics, and motor activities monitored via wearable sensors form part of the comprehensive evaluation. 77 volunteers were recruited for the experiment and randomly randomized to receive either a placebo or one of two dosage levels of ATH434. Every participant received therapy for a full year, which yielded useful information for the planning of a conclusive Phase 3 study.

    Advancing Toward Data Analysis

    With the final patient visit completed, Alterity Therapeutics is now focused on the critical process of cleaning and locking the database. This step will enable the reporting of topline data early next year, a milestone eagerly awaited by stakeholders in the MSA community. The trial’s completion reflects the collaborative efforts of clinical sites, physicians, and patients worldwide, highlighting the strong interest in finding a potential treatment for this debilitating disease.

    Implications for Future Research

    The ATH434-201 trial represents a significant stride in Alterity’s mission to address MSA. By targeting biomarkers associated with disease progression, the study aims to provide robust evidence for ATH434’s therapeutic potential. The findings from this trial will lay the foundation for designing a Phase 3 study, bringing the company closer to a potential breakthrough in the treatment of MSA.

  • What Caused The Alterity (ATHE) Stock To Fell Before Market Opens Today?

    Alterity Therapeutics Limited (ATHE) stock was down -8.00 percent at $1.62 at the last check in pre-market trading. ATHE stock closed Friday session at $1.75, down -18.22% or $0.39. Price of Alterity stock ranged between $1.59 and $1.89. A total of 22.72 million securities were exchanged, a volume greater than ATHE’s YTD volume of 3.29 million and above its 50-day daily volume of 5.76 million.

    The ATHE stock has gained 204.37% in the past 12 months, and it has gained 28.67% in the last week. ATHE stock has gained 30.60% over the last six months and has gained 20.69% over the last three months. After gaining on last Thursday for grant of a new patent, ATHE stock has been consolidating.

    ATHE was granted a patent, what was it?

    ATH434, an early candidate from Alterity, is the first of a new generation of small molecules designed to suppress the formation of pathological proteins that result in neurodegeneration. As ATH434 decreases abnormal brain iron imbalance by preventing the abnormal accumulation of α-synuclein in animal models of disease, it can reduce symptoms of Parkinson’s disease. ATHE’s lead candidate is therefore well suited for treating Parkinson’s disease as well as atypical Parkinsonisms like Multiple System Atrophy (MSA). ATHE has been granted Orphan designation by the US FDA and the European Commission for ATH434 to treat MSA.

    On Thursday, Alterity announced that the United States Patent and Trademark (USPTO) had awarded it a composition of matter patent.

    • ATHE has patented a technology that reroutes excess iron in the nervous system through a new class of iron chaperones, a technology developed by the company.
    • ATHE’s patent illustrates the structure of a small molecule drug candidate that is capable of crossing the blood brain barrier and directly attacking the source of neuropathology.
    • Several important neurodegenerative diseases, including Alzheimer’s and Parkinson’s, have been linked to excess iron in the brain.
    • The USPTO granted the patent, entitled “Compounds for and Methods of Treating Diseases,” following expedited review.
    • More than 150 novel pharmaceutical substances are covered that redistribute labile iron, which is implicated in many neurodegenerative disorders.

    ATHE’s further plans:

    Alterity (ATHE ) expects to start the Phase 2 early next year with its lead clinical candidate ATH434. An experimental small molecule drug called ATH434 is being developed to treat Multiple System Atrophy (MSA), an atypical form of Parkinson’s disease in which iron promotes α-synuclein aggregation.

    In tandem with ATHE’s Phase 2 study results, scientific investigation of ATH434 will enhance the development and optimization of new compounds from the new patent. ATHE will be well-positioned to develop and commercialize drugs for significant neurodegenerative diseases as a result of the patent.