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Alzamend Neuro Inc - ALZN STOCK NEWS

Welcome to our dedicated page for Alzamend Neuro news (Ticker: ALZN), a resource for investors and traders seeking the latest updates and insights on Alzamend Neuro stock.

About Alzamend Neuro Inc (ALZN)

Alzamend Neuro Inc is a clinical-stage biopharmaceutical company dedicated to developing innovative solutions for the treatment of neurodegenerative diseases and psychiatric disorders. The company's mission is to bring relief to the millions of individuals suffering from debilitating conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). By focusing on these critical areas, Alzamend aims to address significant unmet medical needs in the healthcare industry.

Core Technologies and Pipeline

Alzamend Neuro’s current pipeline comprises two groundbreaking therapeutic drug candidates:

  • AL001: A patented ionic cocrystal technology that delivers lithium through a unique therapeutic combination of lithium, proline, and salicylate. This innovative approach seeks to enhance lithium delivery while minimizing side effects, potentially offering a safer and more effective treatment option for bipolar disorder, MDD, and PTSD.
  • ALZN002: A patented method utilizing a mutant-peptide sensitized cell as a cell-based therapeutic vaccine. This technology aims to restore the patient’s immune system's ability to combat Alzheimer’s disease by targeting the underlying immunological deficiencies associated with the condition.

These proprietary technologies reflect Alzamend Neuro’s commitment to leveraging cutting-edge science to develop transformative therapies.

Market and Industry Context

Alzamend operates within the highly specialized biopharmaceutical sector, focusing on neurodegenerative and psychiatric disorders—areas with significant clinical and societal impact. Alzheimer’s disease alone affects millions worldwide, with limited treatment options currently available. By targeting this underserved market, Alzamend positions itself as a potential game-changer in the space. The company’s focus on psychiatric disorders further broadens its market potential, addressing conditions that collectively impact tens of millions globally.

Challenges and Differentiation

As a clinical-stage company, Alzamend faces challenges typical of the biopharmaceutical industry, including high R&D costs, lengthy clinical trials, and stringent regulatory requirements. However, its proprietary technologies and focus on innovative delivery mechanisms provide key differentiators. The company’s approach to lithium delivery through AL001 and its immunological vaccine strategy with ALZN002 set it apart from traditional treatment methodologies, potentially offering safer and more effective solutions.

Commitment to Innovation and Impact

Alzamend Neuro’s mission-driven approach underscores its dedication to improving patient outcomes and addressing critical gaps in treatment. By focusing on both neurodegenerative and psychiatric disorders, the company aims to make a profound impact on public health, providing hope to millions of individuals and their families.

News

Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Post-Traumatic Stress Disorder Patients

Rhea-AI Summary
Alzamend Neuro, Inc. (Nasdaq: ALZN) has received a 'Study May Proceed' letter from the FDA for the initiation of study AL001-PTSD01, a Phase IIA clinical study of AL001 for the treatment of patients with PTSD. The company aims to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, constituting a major improvement over current lithium-based treatments. Alzamend has also received 'Study May Proceed' letters from the FDA for Phase IIA clinical studies of AL001 for the treatment of patients with BD, MDD, and PTSD in the last three months.
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Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Major Depressive Disorder Patients

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Alzamend Neuro, Inc. (Nasdaq: ALZN) announces FDA approval to initiate Phase IIA clinical study of AL001 for treating major depressive disorder (MDD). The study aims to develop a next-generation lithium product that does not require therapeutic drug monitoring, potentially impacting 21 million Americans with MDD. The recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile, qualifying for a 505(b)(2) NDA pathway for FDA approval.
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Alzamend Neuro Regains Compliance with Nasdaq’s Minimum Bid Price Requirement

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Alzamend Neuro, Inc. (Nasdaq: ALZN) has regained compliance with Nasdaq Listing Rule 5550(a)(2) after maintaining a closing bid price of at least $1.00 per share for ten consecutive trading days. The Compliance Notice from Nasdaq confirmed the closure of the matter, unrelated to the minimum Market Value of Listed Securities notice received earlier. Alzamend has until March 25, 2024, to comply with the MVLS Rule.
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Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next‑Generation Lithium Therapeutic Drug Candidate AL001

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Alzamend Neuro, Inc. (Nasdaq: ALZN) announced the completion of Phase IIA study of AL001 for Alzheimer’s patients and healthy subjects, showing a benign safety profile and identifying a candidate dose unlikely to require therapeutic drug monitoring. The company also submitted an IND application for a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for treatment of patients with PTSD, aiming to develop a next-generation lithium product that would not routinely require TDM.
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Alzamend Neuro Announces Reverse Stock Split

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Alzamend Neuro, Inc. (ALZN) has announced a one-for-fifteen reverse stock split of its common stock. The split will be effective on October 31, 2023, and aims to regain compliance with the Minimum Bid Price Requirement of $1.00 per share to maintain listing on The Nasdaq Capital Market.
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Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001

Rhea-AI Summary
Alzamend Neuro has submitted an IND application to the FDA for a Phase IIA study of AL001 for the treatment of patients with major depressive disorder (MDD). AL001 is a novel lithium-delivery system that aims to provide the benefits of lithium while mitigating toxicities. The study may qualify for a 505(b)(2) NDA pathway for FDA approval.
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Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients

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Alzamend Neuro receives FDA approval for Phase IIA clinical study of AL001 for BD type 1. Potential next-generation lithium product could improve treatment for 7 million Americans with BD.
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Alzamend Neuro Granted Extension by Nasdaq Panel to Regain Compliance with the Minimum Bid Price Continued Listing Requirement

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Alzamend Neuro has received an extension from Nasdaq to regain compliance with the minimum $1.00 bid price requirement by November 15, 2023. The extension is subject to Alzamend obtaining stockholder approval for and effecting a reverse stock split by September 29, 2023, and maintaining a $1.00 closing bid price for ten consecutive business days. Alzamend intends to implement the split if stockholder approval is obtained.
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Alzamend Neuro Submits IND Application for Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients

Rhea-AI Summary
Alzamend Neuro has submitted an IND application to the FDA for a Phase IIA study of AL001 for bipolar disorder. AL001 is a novel lithium-delivery system that aims to provide the benefits of lithium while avoiding toxicities. The maximum tolerated dose of AL001 is designed to distribute more lithium to the brain with improved safety compared to currently marketed lithium salts. Alzamend aims to replace a 300 mg TID lithium carbonate dose with a 240 mg TID AL001 lithium equivalent, representing a daily decrease of 20% of lithium. The program may qualify for the 505(b)(2) pathway for FDA approval.
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Alzamend Neuro Announces Positive Phase IIA Clinical Trial Results for AL001

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FAQ

What is the current stock price of Alzamend Neuro (ALZN)?

The current stock price of Alzamend Neuro (ALZN) is $0.7556 as of March 3, 2025.

What is the market cap of Alzamend Neuro (ALZN)?

The market cap of Alzamend Neuro (ALZN) is approximately 4.4M.

What does Alzamend Neuro Inc focus on?

Alzamend Neuro Inc focuses on developing novel therapies for neurodegenerative diseases like Alzheimer’s and psychiatric disorders such as bipolar disorder, MDD, and PTSD.

What are Alzamend Neuro’s key drug candidates?

The company’s pipeline includes AL001, an ionic cocrystal lithium delivery system, and ALZN002, a cell-based therapeutic vaccine for Alzheimer’s disease.

How does Alzamend Neuro differentiate itself in the biopharmaceutical industry?

Alzamend differentiates itself through its proprietary technologies, including innovative lithium delivery mechanisms and immunological approaches to treating Alzheimer’s.

What challenges does Alzamend Neuro face?

As a clinical-stage company, Alzamend faces challenges such as high R&D costs, lengthy clinical trials, and navigating regulatory approval processes.

What market does Alzamend Neuro target?

Alzamend targets the neurodegenerative and psychiatric disorder markets, addressing critical unmet medical needs for conditions like Alzheimer’s, bipolar disorder, MDD, and PTSD.

What is AL001, and how does it work?

AL001 is a patented ionic cocrystal technology that delivers lithium through a combination of lithium, proline, and salicylate, aiming to improve treatment safety and efficacy.

What is ALZN002, and how does it work?

ALZN002 is a cell-based therapeutic vaccine that uses a mutant-peptide sensitized cell to restore the immune system’s ability to combat Alzheimer’s disease.

What is Alzamend Neuro’s mission?

Alzamend Neuro’s mission is to rapidly develop and market safe and effective treatments for neurodegenerative and psychiatric disorders, improving the lives of millions.

What makes Alzamend Neuro’s approach innovative?

Alzamend’s approach is innovative due to its focus on advanced delivery systems like ionic cocrystals and immunological therapies, offering potential breakthroughs in treatment safety and efficacy.

What is the significance of Alzamend Neuro’s work in Alzheimer’s disease?

Alzamend’s work in Alzheimer’s disease is significant as it addresses a major global health crisis with limited existing treatment options, potentially transforming patient care.
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Alzamend Neuro Inc

Nasdaq:ALZN

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ALZN Stock Data

4.43M
5.23M
4.55%
0.94%
2.97%
Biotechnology
Pharmaceutical Preparations
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