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
- 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 PatientsBusiness Wire
- Alzamend Neuro Regains Compliance with Nasdaq's Minimum Bid Price Requirement [Yahoo! Finance]Yahoo! Finance
- Alzamend Neuro Regains Compliance with Nasdaq’s Minimum Bid Price RequirementBusiness Wire
- Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next-Generation Lithium Therapeutic Drug Candidate AL001 [Yahoo! Finance]Yahoo! Finance
- Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next-Generation Lithium Therapeutic Drug Candidate AL001Business Wire
ALZN
Sec Filings
- 11/16/23 - Form 8-K
- 9/29/23 - Form 8-K
- 9/26/23 - Form 4
- ALZN's page on the SEC website