- The U.S. Food and Drug Administration has accepted Alpha Cognition’s (CSE:ACOG) New Drug Application for ALPHA-1062
- The FDA has completed its filing review on the company’s proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s disease
- Adverse events documented across all studies for ALPHA-1062 were less than 2 per cent and no insomnia was observed
- Alpha Cognition Inc. last traded at $0.38 per share
The U.S. Food and Drug Administration (FDA) has accepted Alpha Cognition’s (CSE:ACOG) New Drug Application (NDA) for ALPHA-1062.
The FDA has completed its filing review on the company’s 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 goal date of July 27, 2024.
Based on results from four studies conducted by the company, bioequivalence (the biochemical similarity of two or more drugs) was demonstrated for ALPHA-1062 to galantamine and galantamine ER. Adverse events documented across all studies for ALPHA-1062 were less than 2 per cent 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,” Michael McFadden, chief executive officer of Alpha Cognition said in a news release. “We look forward to continuing our collaboration with the FDA throughout the review process.”
Alpha Cognition is a clinical-stage biopharmaceutical company developing treatments for underserved neurodegenerative diseases.
Alpha Cognition Inc. last traded at $0.38 per share.
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