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 developing novel treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder. News about ALZN often centers on the progress of its two main product candidates, AL001 and ALZN002, as well as financing transactions and corporate actions disclosed through press releases and SEC filings.
Investors following ALZN news can expect detailed updates on the company’s Phase II "Lithium in Brain" clinical program for AL001. These reports describe head-to-head studies of AL001 versus marketed lithium carbonate products, including enrollment milestones, dosing of the first patient, and completion of the clinical portion of trials in healthy subjects. Company announcements also highlight collaborations with Massachusetts General Hospital, Tesla Dynamic Coils BV and QMENTA to support high-resolution brain imaging and AI-driven analysis of lithium distribution.
Alzamend Neuro’s news flow also includes information on its ALZN002 active immunotherapy program targeting beta-amyloid in Alzheimer’s, operational developments in clinical trial management, and capital-raising activities such as private placements of preferred stock and related warrant issuances. Corporate updates, including reverse stock split decisions and governance matters reported on Form 8-K, are frequently summarized in press releases.
This ALZN news page aggregates these updates so readers can review clinical milestones, financing events and regulatory disclosures in one place. For those tracking the development of AL001 and ALZN002, or monitoring Alzamend Neuro’s Nasdaq-listed common stock, the news feed offers a consolidated view of the company’s publicly reported activities and announcements.
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial of AL001 for Major Depressive Disorder (MDD) treatment in Q4 2025 at Massachusetts General Hospital. The study follows the successful completion of a head coil by Tesla Dynamic Coils BV.
The trial will compare AL001 with marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics in MDD patients. Previous mouse studies showed AL001 achieves better brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM).
AL001 aims to overcome limitations of current FDA-approved lithium salts, which require regular monitoring due to a narrow therapeutic window. While lithium lacks FDA approval for MDD treatment, it has been prescribed off-label for decades as an antidepressant augmentation therapy, showing efficacy in multiple randomized controlled trials.
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical study of AL001 for treating post-traumatic stress disorder (PTSD) in Q4 2025. The trial, to be conducted at Massachusetts General Hospital, will compare AL001 with marketed lithium carbonate to evaluate lithium blood and brain pharmacokinetics in PTSD subjects.
The study follows the successful completion of a head coil by Tesla Dynamic Coils BV. Previous mouse studies demonstrated AL001's superior brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM). While lithium lacks FDA approval for PTSD, case reports suggest effectiveness at low doses (300-600 mg/day) in reducing anger, irritability, anxiety, and insomnia in PTSD patients.
The development aims to overcome limitations of current FDA-approved lithium salts, which require regular monitoring due to a narrow therapeutic window. This advancement could benefit over 9 million Americans with PTSD by offering a more effective treatment option with enhanced safety and better brain targeting.
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial for AL001 in treating Bipolar Disorder (BD) in Q3 2025. The study, to be conducted at Massachusetts General Hospital, will compare AL001 with marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics.
The trial follows the successful completion of a head coil by Tesla Dynamic Coils BV. Previous mouse studies showed AL001 achieves better brain absorption while maintaining lower blood lithium levels. The novel formulation aims to eliminate the need for lithium therapeutic drug monitoring (TDM), addressing limitations of current FDA-approved lithium salts that require regular monitoring due to narrow therapeutic windows.
AL001's potential advantages include enhanced safety, improved brain targeting, and reduced systemic side effects, particularly regarding kidney and thyroid complications commonly associated with traditional lithium therapies. This advancement could benefit over 7 million Americans with BD by offering a more effective treatment option.
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate the first of five phase II clinical studies for AL001 in the second quarter of 2025. The initial study will be conducted at Massachusetts General Hospital with healthy human subjects following the successful development of a novel head coil by Tesla Dynamic Coils BV.
This head-to-head study will compare AL001 with marketed lithium carbonate products, focusing on lithium blood and brain pharmacokinetics. Previous mouse studies showed AL001 provides better brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM).
AL001 aims to overcome limitations of current FDA-approved lithium salts (carbonate and citrate), which require regular monitoring due to narrow therapeutic windows and multiple daily doses. The novel formulation could represent a significant advancement in treating Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD by reducing kidney and thyroid side effects associated with traditional lithium therapies.
Alzamend Neuro (NASDAQ: ALZN) announced the completion of a groundbreaking head coil by Tesla Dynamic Coils BV, essential for five upcoming Phase II clinical trials. The trials, conducted at Massachusetts General Hospital, will compare AL001 versus marketed lithium carbonate in healthy individuals and patients with Alzheimer's, bipolar disorder, major depressive disorder, and PTSD.
The specialized head coil enables whole-brain imaging of lithium with high resolution, allowing precise quantification within brain structures. Previous nonclinical studies showed AL001 optimizes brain absorption with lower blood concentration levels compared to lithium carbonate. This innovation could potentially eliminate the need for lithium therapeutic drug monitoring while providing safer dosing options and expanding the therapeutic index.
Alzamend Neuro (NASDAQ: ALZN), a clinical-stage biopharmaceutical company, has announced its participation in the upcoming Sequire Investor Summit from January 21-23, 2025, at the Condado Vanderbilt in Puerto Rico. CEO Stephan Jackman will present on January 22, 2025, at 11:30 a.m. ET.
The presentation will highlight the company's improved financial position and plans for five Phase II trials of AL001 to be initiated in 2025 in partnership with Massachusetts General Hospital. The company focuses on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.
The Sequire Investor Summit, in its third edition, will feature 75+ presenting companies and host over 500 investors, funds, family offices, and analysts. Registration is mandatory for attendance through the provided link.
Alzamend Neuro (NASDAQ: ALZN) announced its upcoming poster presentation at the Society of Toxicology Annual Meeting in March 2025, featuring non-clinical data on AL001, a lithium-based treatment. The presentation will showcase comparative data between AL001 and lithium carbonate in Alzheimer's transgenic mice. Key findings demonstrate AL001's enhanced brain-specific lithium delivery with minimized systemic exposure, showing no adverse effects while maintaining higher brain lithium concentrations at lower doses compared to lithium carbonate.
Following successful Phase I and IIA trials, Alzamend plans five Phase II trials in partnership with Massachusetts General Hospital in 2025, targeting treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The company aims to pursue FDA 505(b)(2) approval pathway for AL001.
Alzamend Neuro (ALZN) reported Q2 2025 financial results, showing significant balance sheet improvements. Net cash from financing activities reached $8.3 million for the six months ended October 31, 2024. Stockholder equity improved to $3.8 million from a deficit of $2.6 million, while cash position strengthened to $4.1 million from $0.4 million.
The company secured financing agreements including a $25 million preferred stock and warrants purchase agreement and a $6.5 million at-the-market sales agreement. These improvements helped regain Nasdaq compliance and prepare for five clinical trials in 2025. The company's lead drug candidate AL001, a novel lithium therapy, is advancing to Phase II trials at Massachusetts General Hospital, while ALZN002, an immunotherapy for Alzheimer's, plans trial resumption in 2025.
Alzamend Neuro (NASDAQ: ALZN) has completed analyzing data from a nonclinical study comparing AL001, their novel lithium formulation, with lithium carbonate in Alzheimer's transgenic mice. The study, conducted at the University of South Florida, revealed that AL001 achieved higher brain lithium concentrations while maintaining lower plasma levels compared to lithium carbonate, particularly at lower doses. The results showed no adverse effects, suggesting enhanced safety and efficacy potential for treating Alzheimer's, bipolar disorder, major depressive disorder, and PTSD. The company plans to proceed with five Phase II 'Lithium in Brain' clinical trials in partnership with Massachusetts General Hospital.
Alzamend Neuro (ALZN) has received the full data set from its multiple ascending dose clinical trial for AL001, a treatment for dementia related to Alzheimer's. The data confirms the positive topline results announced in June 2023, identifying a maximum tolerated dose (MTD) that is unlikely to require lithium therapeutic drug monitoring. The MTD delivers lithium at a lithium carbonate equivalent dose of 240 mg, taken three times daily.
AL001 is a novel lithium-salicylate/L-proline engineered ionic cocrystal designed to overcome toxicities associated with conventional lithium salts. It promises a next-generation lithium treatment with an enhanced safety profile and improved brain bioavailability. This innovation could potentially benefit the 43+ million Americans afflicted with Alzheimer's, bipolar disorder, major depressive disorder, and PTSD.
Alzamend plans to further evaluate AL001 in five 'Lithium in Brain' Phase II clinical trials in partnership with Massachusetts General Hospital.
FAQ
What is the current stock price of Alzamend Neuro (ALZN)?
What is the market cap of Alzamend Neuro (ALZN)?
