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.
Alzamend Neuro, Inc. (Nasdaq: ALZN) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for neurodegenerative diseases and psychiatric disorders. With a primary focus on Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD), the company's mission is to bring safe and effective solutions to the over 43 million Americans suffering from these conditions.
Alzamend Neuro's current pipeline includes two promising therapeutic candidates:
- AL001: A patented ionic cocrystal technology that delivers lithium through a combination of lithium, proline, and salicylate. This advanced delivery system aims to provide the benefits of existing lithium treatments while mitigating toxicity and eliminating the need for therapeutic drug monitoring (TDM). Recent Phase IIA studies have shown a favorable safety profile and identified a maximum tolerated dose that offers improved brain lithium levels with lower systemic exposure.
- ALZN002: A novel cell-based therapeutic vaccine that uses a mutant-peptide sensitized cell to enhance the patient's immune system’s ability to fight Alzheimer’s disease. This approach seeks to restore immune function and provide long-term benefits for patients.
Alzamend has made significant strides in clinical development, with recent achievements including the submission of an investigational new drug (IND) application to the FDA for a Phase IIA study of AL001 in MDD patients. Additionally, the company completed a Phase IIA study of AL001 in Alzheimer's patients, revealing a benign safety profile potentially qualifying for a 505(b)(2) NDA pathway for FDA approval.
Financially, Alzamend is actively working to secure funding and maintain compliance with Nasdaq listing requirements. Recently, the company announced a reverse stock split to meet the Minimum Bid Price Requirement and a major private placement agreement to raise up to $25 million for further clinical trials and operational needs.
Alzamend Neuro has partnered with the University of South Florida Research Foundation, Inc. for exclusive worldwide licenses on all its product candidates. As Alzamend continues to advance its clinical programs, the company remains focused on its mission to bring innovative, safe, and effective treatments to market, addressing the urgent needs of millions of patients.
Ault Alliance has announced that Alzamend Neuro has initiated its Phase I/IIA clinical trial for the immunotherapeutic vaccine ALZN002 targeting Alzheimer’s. This trial aims to establish the appropriate dosage for patients before a larger Phase IIB trial, expected within three months post-data collection. Ault Alliance holds approximately 11.3 million shares of Alzamend and has rights to acquire more, potentially bringing its total ownership to 23.8 million shares, or 22% of Alzamend's outstanding stock. The company emphasizes continued support for Alzamend's mission against Alzheimer’s disease.
Alzamend Neuro, Inc. (Nasdaq: ALZN) has initiated a Phase I/IIA clinical trial for its immunotherapy vaccine ALZN002, aimed at treating mild to moderate Alzheimer's dementia. The trial seeks to evaluate the safety, tolerability, and efficacy of ALZN002 against a placebo, involving 20-30 subjects. The primary objective is to identify the suitable dosage for a larger Phase IIB trial, planned to launch within three months post-data collection. ALZN002, derived from patients' immune cells, targets amyloid-beta proteins associated with Alzheimer's, potentially offering a safer, less frequent treatment method. Pre-clinical studies show promising results with no adverse effects reported.
Alzamend Neuro, Inc. (NASDAQ: ALZN), focusing on Alzheimer's disease and other disorders, has received a "Study May Proceed" letter from the FDA for its ALZN002 immunotherapy. This approval allows the company to initiate a Phase I/IIA clinical trial for treating mild to moderate dementia related to Alzheimer's. ALZN002, a patient-specific immunotherapy, aims to enhance the immune response against amyloid-beta proteins, potentially altering disease progression. Initial dosing is expected in Q1 2023. The IND application is supported by pre-clinical studies indicating safety and significant amyloid reductions in animal models.
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