Alzamend Receives FDA “Study May Proceed” Notification for PhIIA Trial of AL001
ATLANTA--(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.
Alzamend Neuro Regains Compliance with Nasdaq’s Minimum Bid Price Requirement
Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in AL001
Alzamend Neuro Announces Reverse Stock Split
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
Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Alzamend Neuro Granted Extension by Nasdaq Panel to Regain Compliance with the Minimum Bid Price Continued Listing Requirement
ATLANTA--(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 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-BD01, a Phase IIA clinical study of AL001 for BD.
ATLANTA--(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 (“BPD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it has successfully identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”), is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Also, this MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients.