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Alzamend Neuro, Inc. reports clinical-stage biopharmaceutical developments for therapies aimed at Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder. Its pipeline centers on AL001, a patented ionic cocrystal formulation that delivers lithium with salicylate and L-proline, and ALZN002, a cell-based therapeutic vaccine approach designed to target Alzheimer's beta-amyloid.
Recurring news includes Phase II “Lithium in Brain” clinical study updates, brain and blood lithium pharmacokinetic and pharmacodynamic data, research activity with Massachusetts General Hospital, scientific presentations, annual financial results and financing actions supporting the company's clinical programs.
Alzamend Neuro (ALZN) has regained compliance with Nasdaq Listing Rule 5550(b)(1) on stockholders' equity, following a Nasdaq notice dated September 14, 2026.
To meet the rule, the company needed minimum stockholders' equity of $2.5 million and reported equity of $5,802,680 in its Form 10-Q for the quarter ended July 31, 2026, filed on September 10, 2026. Nasdaq confirmed that Alzamend now complies with the Equity Rule and that the matter is closed. Earlier, on March 20, 2026, Nasdaq had notified Alzamend that it did not meet certain continued listing standards and set a deadline, later extended to September 16, 2026, to regain compliance. The CEO said the company will now focus on advancing AL001 through four Phase II clinical trials with Massachusetts General Hospital, including completed work in a healthy cohort and an ongoing bipolar disorder cohort.
Alzamend Neuro (Nasdaq: ALZN)/b) announced that neuroimaging data from its completed randomized Phase 1/2A clinical trial of , a patented organic lithium salt, has been accepted for poster presentation at Neuroscience 2026, the Society for Neuroscience annual meeting to be held November 14–18, 2026 in Washington, DC.
The poster, titled “Assessing Treatment-Associated Brain Network Changes Following a Novel Lithium Treatment Using 7T Resting-State fMRI – Results from a Randomized Phase 1/2A Clinical Trial,” will be presented in the Neuropsychiatric Disorders session (PSTR337) on November 18, 2026, from 8:00 a.m. to 12:00 p.m. The study used a crossover design comparing AL001 with lithium carbonate in healthy subjects, integrating 7T resting-state fMRI, MRI and MRS to assess brain network connectivity, lithium brain and blood levels, and biomarker effects.
According to Alzamend, results showed AL001 matched blood lithium levels of standard lithium carbonate while being designed to enable reduced systemic exposure, supporting its development as a differentiated lithium therapy for Alzheimer’s disease, bipolar disorder type 1, major depressive disorder and PTSD.
Alzamend Neuro (Nasdaq: ALZN) announced that pharmacokinetic imaging data from its completed Phase 1/2A trial of AL001, a patented organic lithium salt, has been accepted for an oral presentation at the ISMRM Workshop on Beyond Protons: Challenges and Advances in X-Nuclei MR, held September 28–October 1, 2026 at the Universitat Oberta de Catalunya in Barcelona, Spain.
The 10-minute proffered-paper talk, scheduled for September 29, 2026 at 1:35 PM local time, will present first-of-its-kind 7T MRI pharmacokinetic imaging results in healthy subjects comparing AL001 with lithium carbonate in a randomized crossover design. According to Alzamend, the study confirmed that AL001 matched blood lithium levels of standard lithium carbonate while being designed to reduce systemic exposure and support a differentiated, potential dose-sparing profile across Alzheimer's disease, bipolar disorder type 1, major depressive disorder and post-traumatic stress disorder.
Alzamend Neuro (Nasdaq: ALZN) entered a Securities Purchase Agreement with Ault Lending under which Ault Lending agreed to purchase up to $25 million of newly designated Series D Convertible Preferred Stock. According to Alzamend, the initial tranche of $7.5 million has closed for 7,500 Preferred Shares at $1,000 per share, each with a stated value of $1,050.
The deal is structured as 17 tranche closings. A second tranche of $2.5 million is expected within ten business days after SEC effectiveness of a resale registration statement, with the remaining $15 million targeted in approximately monthly $1 million tranches over about 15 months, all subject to customary conditions. Alzamend will pay Ault Lending a 2% origination fee on each tranche and plans to use proceeds for working capital and to advance its clinical programs, including its next‑generation lithium product and Phase I/IIA immunotherapeutic vaccine trial.
Alzamend Neuro (NASDAQ: ALZN) reported preliminary pharmacodynamic MRS data from a healthy-subject study (N=6) at Massachusetts General Hospital on April 7, 2026. After two weeks of blood-bioequivalent AL001 versus lithium carbonate, AL001 trended toward myo-inositol reduction in 17 of 18 brain regions and showed minimal glutamate effects in 10 of 18 regions. Results are qualitative and require statistical confirmation in larger, adequately powered patient studies now underway.
Alzamend Neuro (Nasdaq: ALZN) reported positive Phase II topline data for AL001 on March 26, 2026. AL001 achieved bioequivalence to lithium carbonate (101% total exposure; 97% peak) and showed ~7.8% higher whole-brain lithium with faster peak brain uptake (6.7h vs. 8.4h).
Six subjects per arm produced directional, non‑definitive results; a second Phase II in bipolar disorder is underway with topline data expected Q3 2026. Further trials depend on capital raising.
Alzamend Neuro (Nasdaq: ALZN) initiated a Phase II crossover trial of AL001 in bipolar disorder type 1 at Massachusetts General Hospital to compare brain and blood lithium pharmacokinetics versus lithium carbonate. Topline BD data are expected in Q3 2026; healthy-subject imaging topline data expected end-March 2026.
The study uses 14-day TID dosing periods, a 14-day washout, intensive 24-hour PK sampling with MRI/MRS lithium imaging, and an engineered head coil; the selected MTD equals a lithium carbonate equivalent of 240 mg TID.
Alzamend Neuro (Nasdaq: ALZN) announced completion of the clinical portion of its Phase II study of AL001 in healthy subjects on Nov 19, 2025. The study compared lithium blood and brain pharmacokinetics of AL001 versus a marketed lithium carbonate product using a proprietary high-resolution whole-brain lithium imaging head coil from Tesla Dynamic Coils BV.
Topline data are expected in Q1 2026. Company says results will inform planned Phase II trials in Alzheimer's, bipolar disorder, major depressive disorder, and PTSD next year; prior mouse studies reportedly showed higher brain uptake with lower blood lithium levels.
Alzamend Neuro (Nasdaq: ALZN), a clinical-stage biopharmaceutical company, will present a poster at the 2025 Military Health System Research Symposium (MHSRS) from August 4-7 in Orlando, Florida.
The presentation, scheduled for August 6, 2025, will focus on quantitative differences in lithium brain-to-plasma exposure between AL001 and lithium carbonate in PTSD subjects. The study aims to contribute to a database comparing brain-plasma assessments across various neurological disorders.
CEO Stephan Jackman will present findings related to AL001, which is being developed for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD. The company plans to engage with DoD funding directors to pursue non-dilutive funding opportunities through grants.
Alzamend Neuro (Nasdaq: ALZN) reported its annual financial results for FY2025 and provided updates on its clinical programs. The company significantly improved its financial position with stockholder equity reaching $4.0 million and cash holdings of $3.9 million as of April 30, 2025. In June 2025, Alzamend completed a $5 million private placement ahead of schedule.
The company's lead candidate AL001, a lithium-based treatment for Alzheimer's, bipolar disorder, major depressive disorder, and PTSD, began the first of five Phase II trials at Massachusetts General Hospital in May 2025. Their second candidate, ALZN002, an immunotherapy treatment for Alzheimer's, faced delays after their CRO terminated the agreement in February 2024, and the company is seeking a new partner to continue the Phase I/IIA trial.