Alzamend Neuro, Inc. ALZN

Halt again?

23/10/2023 08:00AM ET
Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001
Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval
Alzamend recently completed a Phase IIA Study of AL001 in Alzheimer's patients and healthy subjects showing a benign safety/ tolerability profile while characterizing dosing levels unlikely to require therapeutic drug monitoring
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 that it has submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for adjunctive treatment of patients with MDD.

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