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.
Alzamend Neuro, Inc. (Nasdaq: ALZN) has appointed Dr. Terri Hunter to its Scientific Advisory Board. Dr. Hunter, a Technology Transfer Specialist with experience managing patents for Alzamend’s candidates AL001 and AL002, expresses enthusiasm for the company's progress in clinical trials. AL001 is a novel lithium-delivery system intended for Alzheimer’s treatment, aiming to provide benefits without current toxicities. Alzamend plans to begin a Phase 2 study involving Alzheimer's patients and submit an investigational new drug application for AL002 in Q2 2022.
Alzamend Neuro has confirmed positive results from its Phase 1 trial of AL001, a lithium-delivery system intended for Alzheimer's treatment. The data demonstrate that AL001 is bioequivalent to marketed lithium carbonate, with a significantly lower dosage and similar plasma concentration curves. No serious adverse events occurred, indicating a favorable safety profile. With over 40 million Americans affected by related conditions, AL001 may reduce the need for lithium monitoring and provide a safer alternative. The company plans to initiate a Phase 2 study in Alzheimer's patients soon.
Alzamend Neuro has reported positive topline results from its Phase 1 clinical trial for AL001, a lithium delivery system aimed at treating Alzheimer's disease. The trial demonstrated that AL001 is bioequivalent to marketed lithium carbonate, suggesting the potential for effective treatment at lower doses. AL001's safety profile is benign with no significant adverse effects noted. The company plans to initiate a Phase 2 trial and pursue regulatory applications for several psychiatric disorders within the year, addressing a critical public health need.
Alzamend Neuro, Inc. (Nasdaq: ALZN) recently announced that the topline data for its Phase 1 clinical trial of AL001, aimed at treating dementia related to Alzheimer’s, will be released in mid- to late-December 2021. The company aims to utilize these results to swiftly transition into a Phase 2 study in early 2022. In addition, the FDA has agreed to a combined Phase 1/2 clinical study for AL002, a cell-based vaccine aimed at Alzheimer's, with an IND submission planned for Q2 2022. The positive FDA feedback is a significant step for Alzamend in its development of innovative therapies for neurodegenerative diseases.
Ault Global Holdings (NYSE American: DPW) reported significant financial results for the nine months ending September 30, 2021. Revenue increased by 167% to $44.6 million, bolstered by lending and trading activities, contributing $19.6 million. However, Q3 saw a revenue decline of $36.5 million, totaling negative $30.8 million, mainly due to unrealized losses in investments, particularly a $33.4 million loss from Alzamend Neuro (Nasdaq: ALZN). Despite a net income of $1.3 million for nine months, Q3 net loss was $42.9 million.
Alzamend Neuro has received FDA approval to proceed with a combined Phase 1 and 2 clinical trial for its Alzheimer’s treatment AL002. The therapy aims to utilize a mutant-peptide sensitized cell to enhance the immune system's ability to combat Alzheimer’s by reducing beta-amyloid plaques. Alzamend intends to file its IND application by the end of November 2021 and begin the clinical trial in early 2022, based on positive preclinical results and feedback from the FDA.
Alzamend Neuro has achieved a significant milestone by dosing the first group of participants in a six-month Phase I comparative study for AL001, aimed at treating dementia related to Alzheimer's disease. This study will assess the safety and pharmacokinetics of AL001 compared to conventional lithium treatments, involving at least 24 healthy participants. The company believes AL001 could offer significant improvements over existing therapies for the over 40 million Americans suffering from Alzheimer's.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced a partnership with Altasciences to conduct a six-month Phase I clinical study for AL001, aimed at treating dementia related to Alzheimer’s disease. The study, commencing in September 2021, will evaluate the pharmacokinetics of AL001 compared to a marketed lithium carbonate capsule. AL001 utilizes patented ionic cocrystal technology designed to enhance lithium delivery. Alzamend believes this formulation may significantly improve treatment options for Alzheimer’s and other neurodegenerative diseases, reducing potential regulatory burdens.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced an additional investment from Digital Power Lending, LLC, totaling $2 million for 1,333,333 shares at $1.50 each. This funding follows the FDA's approval for a Phase 1a study of AL001, a lithium-based therapy for Alzheimer's-related dementia. As part of a March 2021 agreement, further capital will be provided based on future milestones. CEO Stephan Jackman expressed gratitude for the support, indicating that the funding positions Alzamend well for advancing clinical trials without needing new capital.
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