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Tag: Alterity

  • 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.

  • Alterity Therapeutics Ltd. (ATHE) Stock Surges as Scope of Patent is Explored in Treatment of Alzheimer’s and Parkinson’s

    Alterity Therapeutics Ltd. (ATHE) stock prices were down by 2.11%, bringing the price per share down to USD$1.39 at the end of the trading day. Subsequent premarket fluctuations saw the stock surge by 30.22%, bringing it up to USD$1.81.

    USPTO Patent

    July 1st, 2021 saw the company announce that it had been granted a new composition of matter patent by the United States Patent and Trademark Office (USPTO). This patent will offer the company a vast monopoly over a new class of iron chaperons, which is a technology capable of redistributing excess iron in the central nervous system. The structural backbone presented in the patent serves as the foundation for small molecule drug candidates that have the capacity to cross the blood brain barrier, thus directly attacking sources of various neuropathologies.

    Scope of Patent

    Alzheimer’s and Parkinson’s are associated with excess levels of iron in the brain, as are various other important neurodegenerative diseases. Titled “Compounds for and Methods of Treating Diseases”, the patent was granted following an expedited review by the USPTO. It includes coverage of more than 150 novel pharmaceutical compositions that are designed to facilitate the redistribution of the labile iron that is involved in a myriad of neurodegenerative conditions.

    Dissecting the Patent

    The company is set to launch the Phase 2 trial of ATH434, its lead clinical candidate, by the end of the 2021 year. The small molecule drug is being developed for Multiple System Atrophy (MSA), which is a form of atypical parkinsonism where iron is essential in pathogenesis by promoting α-synuclein aggregation. Results from the Phase 2 study, in conjunction with the ongoing scientific investigation of the treatment, will facilitate the development and optimization of novel compounds that are expected to emerge from the new patent

    Continued Expansion

    The significant milestone represents an important part of our corporate strategy aimed to expand the company’s portfolio of potential disease modifying treatments for the demographic affected by neurodegenerative diseases. The newly covered compounds are designed to target excess brain iron resulting from the conditions, with the company hoping to identify a new clinical candidate by the time the lead clinical program results are reported.

    Future Outlook for ATHE

    Armed with the lucrative potential afforded by the granting of the patent, ATHE is poised to capitalize on the continued development of its lead product. The company is keen to continue its trajectory of success as it continues to explore added opportunities arising from the patent. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to usher in significant and sustained increases in shareholder value.

  • 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.

  • Alterity Therapeutics Ltd. (ATHE) Stock Skyrockets as Meme Stock Phenomenon Continues to Proliferate Stock Exchange

    Alterity Therapeutics Ltd. (ATHE) stock prices were down by 1.52% as of the market closing on June 30th 2021, bringing the price per share down to USD$1.30 at the end of the trading day. Subsequent pre-market fluctuations saw the stock skyrocket by a massive 66.92%, bringing it up to USD$2.17.

    EMA Guidance

    June 23rd, 2021 saw the company announce guidance it had received from the European Medicines Agency (EMA) in regard to key aspects of ATHE’s Phase 2 clinical trial for the treatment of Multiple System Atrophy (MSA) with its investigational drug ATH434. The company is actively preparing for the impending launch of the Phase 2 trial, which is scheduled to commence in the second half of 2021.

    About the EMA

    The EMA is an agency with jurisdiction in the European Union, with the responsibility of evaluating and supervising medicinal products. The agency plays a crucial role in the timely support of the sound development of high-quality, effective, and safe medicines for the treatment of respective patients. With their advice not being binding, the EMA influences improved trial designs to facilitate more robust and complete data in the evaluation of treatments.

    Scope of ATH434

    With MSA affecting a sizeable portion of the U.S population and the absence of any approved treatments for MSA, the scope of ATH434 is extensive. There is no regulatory precedence for defining clinical endpoints or guiding patient enrollment, thus requiring greater consideration in developing a trial design that is most suitable. Accordingly, the company has recruited clinical experts and global regulatory authorities for input. ATHE is also conducting BioMUSE, a natural history study designed to identify biomarkers and clinical endpoints most appropriate to capture efficacy signals in the Phase 2 study.

    Meme Stock Phenomenon

    Despite the promising development of the course of the ATH434 trial, the recent surge in ATHE’s stock price seems unmerited. Such drastic movement in the absence of news coverage or changes in fundamentals likely signals the company having been the latest target of the meme stock phenomenon that has resurged in the stock market. Driven by Reddit-based retail investors, underperforming companies with high short interest are selected for a coordinated short squeeze.

    Future Outlook for ATHE

    Armed with the recent surge in its equity value, ATHE finds itself with a fortuitous influx of resources to leverage in order to ensure more organic growth. Investors are hopeful that the company will manage to use the resources at its disposal to continue its trajectory of success.