Alzamend Neuro Receives FDA "Study May Proceed" Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Major Depressive Disorder Pat...
Alzamend Neuro, Inc. (ALZN)
Company Research
Source: Yahoo! Finance
Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval ATLANTA, November 20, 2023 BUSINESS WIRE Alzamend Neuro, Inc. (Nasdaq: ALZN) (" Alzamend "), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (" Alzheimer's "), bipolar disorder (" BD "), major depressive disorder (" MDD ") and post-traumatic stress disorder (" PTSD "), today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration (" FDA ") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treatment of patients with MDD. "We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for MDD. Although lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades," said Stephan Jackman, Chief Ex
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ALZN
News
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- Alzamend Neuro Announces Favorable Decision from Nasdaq Hearings PanelBusiness Wire
- Alzamend Neuro Announces Initial Closing of Private Placement [Yahoo! Finance]Yahoo! Finance
- Alzamend Neuro Announces Initial Closing of Private PlacementBusiness Wire
ALZN
Sec Filings
- 7/12/24 - Form 8-K
- 7/10/24 - Form 424B3
- 7/10/24 - Form EFFECT
- ALZN's page on the SEC website