Alzamend Neuro, Inc. (NASDAQ: ALZN) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of novel treatments for neurodegenerative diseases and psychiatric disorders. Shares of the biopharmaceutical company are surging 39% through afternoon trading on Thursday, September 30, 2021. Over the past three months, Alzamend Neuro has seen average daily volume of 2.09 million shares. However, volume of 46.66 million shares or dollar volume of $148.38 million, has already exchanged hands through Thursday’s afternoon trading.
Shares of Alzamend Neuro are rallying after the company announced that it has received a positive pre-IND response from the U.S. Food and Drug Administration (FDA) regarding its AL002 candidate. AL002 utilizes a mutant-peptide sensitized cell as a cell-based vaccine that is designed to restore a patient’s immunological system in order to fight Alzheimer’s.
The FDA’s response to the company’s Type B Pre-Investigational New Drug (IND) application provides a path forward for the company to continue clinical development of the candidate. With the FDA’s approval of Alzamend Neuro’s plans to conduct a combined Phase 1 and 2 clinical trial for AL002, the company estimates filing the IND by the end of November 2021. Initiation of the AL002 clinical trial is anticipated to begin sometime during the first quarter of 2022.
“We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit the IND application to initiate a clinical trial for AL002,” said Stephan Jackman, Alzamend’s Chief Executive Officer. “Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents. Based on AL002’s positive toxicology results, the biologic nature of this product and the urgent need to deliver treatments for Alzheimer’s to patients, Alzamend proposed, and the FDA agreed, to conduct a combined Phase 1/2 study. We appreciate the FDA’s recommendations, guidance and other helpful advice. We plan to augment our proposed clinical trial protocols and proceed accordingly.”
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