Alzamend Neuro Inc Stock Price, News & Analysis

Alzamend Neuro (NASDAQ: ALZN) has enrolled its first patient in a Phase II clinical trial for AL001, a novel lithium formulation, at Massachusetts General Hospital. The study aims to compare AL001's brain absorption and blood levels against marketed lithium carbonate in healthy subjects, with topline data expected by year-end 2025.

AL001 shows promise in delivering lithium more effectively to the brain while maintaining lower blood levels, potentially eliminating the need for therapeutic drug monitoring (TDM). Previous mouse studies demonstrated better brain absorption with reduced systemic exposure. The treatment targets multiple conditions, including Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, potentially benefiting over 43 million Americans.

Alzamend Neuro (NASDAQ: ALZN) has initiated its first of five Phase II clinical trials for AL001, a novel lithium-based treatment, at Massachusetts General Hospital. The study will compare AL001 with marketed lithium carbonate to evaluate brain and blood pharmacokinetics in healthy subjects, with topline data expected by year-end.

AL001 represents a potential breakthrough in lithium treatment, showing better brain absorption while maintaining lower blood levels in previous mouse studies. The drug aims to eliminate the need for therapeutic drug monitoring (TDM), addressing a major limitation of current lithium treatments. This advancement could benefit over 43 million Americans affected by Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.

Alzamend Neuro (NASDAQ: ALZN) has announced a 1-for-9 reverse stock split effective May 12, 2025. The clinical-stage biopharmaceutical company, focused on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, implemented this measure primarily to maintain Nasdaq listing compliance with the minimum bid requirement of $1.00 per share.

The company's outstanding shares will decrease from approximately 7,208,591 to 800,954 shares. The stock will continue trading under the symbol "ALZN" with a new CUSIP number 02262M605. While the split affects all issued and outstanding shares, including equity incentive plans and outstanding options/warrants, it won't alter stockholders' percentage ownership. Stockholders entitled to fractional shares will receive cash payments instead.

Alzamend Neuro (NASDAQ: ALZN) has partnered with QMENTA, an AI medical imaging company, to support five upcoming Phase II clinical trials of AL001 at Massachusetts General Hospital. The trials will compare AL001 to marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics in healthy subjects. AL001 aims to deliver lithium more effectively to the brain while maintaining lower blood levels, potentially eliminating the need for therapeutic drug monitoring. Previous mouse studies showed improved brain absorption with reduced systemic exposure. The partnership leverages QMENTA's cloud-based platform for managing and analyzing medical imaging data, ensuring regulatory compliance and operational efficiency. This collaboration targets treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD. The study aims to demonstrate AL001's targeted effectiveness and reduced side effects compared to traditional lithium salts, which require frequent monitoring due to narrow therapeutic windows.

Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial of AL001 for Alzheimer's disease 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 Alzheimer's 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).

The company previously completed a Phase IIA multiple-ascending dose study, establishing a maximum tolerated dose that likely won't require TDM while providing effective lithium dosing. AL001 is designed to improve lithium distribution in the brain while reducing exposure to other organs, potentially offering a safer profile compared to current lithium salts.

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.