Hello. We will be attending the MoneyShow in Las Vegas this week and look forward to meeting you if you will be in attendance. Alzheimer’s is again the focus for today. We wanted to note that Cognition Therapeutics (CGTX) (not to be confused with Alpha Cognition (ACOG) that we will be writing about below) reported Phase 2 results that did not achieve statistical significance. Shares closed down 44% on Monday.
Reformulated Alzheimer’s Drug Receives FDA Approval, Launching Q1 2025
On Monday, the FDA approved Alpha Cognition’s (CSE: ACOG) therapy ZUNVEYL in mild to moderate Alzheimer’s disease.
Unlike existing treatments that primarily target amyloid-beta plaques, ZUNVEYL (benzgalantamine) utilizes a dual mechanism of action. On one hand ZUNVEYL is a prodrug meaning it gets metabolized in the body into its active form, galantamine. Galantamine is an acetylcholinesterase inhibitor (AChEI) that helps preserve acetylcholine, a key neurotransmitter that helps regulate memory, attention, and motivation. Galantamine is well studied and was previously approved in 2001 as an immediate-release product under the brand name Razadyne. The drug is no longer manufactured by its developer Janssen but is available as a generic.
ZUNVEYL is also an allosteric potentiator of the α-7 nicotinic acetylcholine and α4β2 receptors, which helps facilitate the release of acetylcholine from nerve cells and potentially amplifies the drug’s therapeutic effect. This new version of galantamine is designed to bypass absorption in the GI tract which has shown improved tolerability and low rates of insomnia. ZUNVEYL is the second AD treatment to be approved in over a decade.
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