EXCLUSIVE: Alzamend Neuro Receives FDA Go-Ahead Letter For Mid-Stage Major Depressive Disorder Study
Portfolio Pulse from Vandana Singh
Alzamend Neuro Inc (NASDAQ:ALZN) has received a 'Study May Proceed' letter from the FDA to initiate a Phase 2A clinical study of AL001 for major depressive disorder (MDD). The company's CEO, Stephan Jackman, highlighted the potential of AL001 as a next-generation lithium product that may not require routine therapeutic drug monitoring, which could be a significant improvement for MDD treatments. Alzamend's Phase IIA study of AL001 in Alzheimer's patients indicated a benign safety profile. The first patient for the MDD study is expected to be dosed in Q1 2024. ALZN shares closed at $1.69 on Friday.
November 20, 2023 | 12:31 pm
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POSITIVE IMPACT
Alzamend Neuro Inc received FDA approval to proceed with a Phase 2A study of AL001 for MDD, indicating progress in their clinical pipeline and potential for a new MDD treatment.
The FDA's 'Study May Proceed' letter is a significant regulatory milestone for Alzamend Neuro, indicating that the company can move forward with its clinical study for MDD treatment. This news is likely to be viewed positively by investors as it demonstrates progress in the company's product development and could potentially lead to a new treatment option for MDD. The anticipation of the study's initiation and the potential benefits of AL001 as a next-generation lithium product could drive investor optimism and increase the stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100