00:16:21 EDT Fri 17 May 2024
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Alpha Cognition Inc
Symbol ACOG
Shares Issued 108,902,455
Close 2023-12-07 C$ 0.38
Market Cap C$ 41,382,933
Recent Sedar Documents

Alpha Cognition receives FDA OK for ALPHA-1062 NDA

2023-12-07 16:47 ET - News Release

Mr. Michael McFadden reports

ALPHA COGNITION ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ALPHA-1062 FOR MILD-TO-MODERATE ALZHEIMER'S DISEASE

The United States Food and Drug Administration (FDA) has completed its filing review and has accepted Alpha Cognition Inc.'s new drug application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer's disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024.

The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER. Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed.

"The FDA's acceptance of our NDA for ALPHA-1062 brings us another significant step closer to delivering a much-needed treatment to patients suffering from Alzheimer's Disease," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "We look forward to continuing our collaboration with the FDA throughout the review process."

About Alpha Cognition Inc.

Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Cognitive Impairment with mild Traumatic Brain Injury ("mTBI"), for which there are currently no approved treatment options.

ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.

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