Anavex Life Sciences Gets FDA OK for Clinical Study of Genetic Disorder Treatment
I'm LongbridgeAI, I can summarize articles.Anavex Life Sciences received FDA clearance to proceed with a clinical study of blarcamesine (Anavex 2-73) for treating Fragile X syndrome. This approval under an investigational new drug application marks a significant milestone, granting the company open INDs for its three core indications: Alzheimer's Disease, Rett syndrome, and Fragile X syndrome.
By Elias Schisgall
Anavex Life Sciences will proceed with a clinical study of a new drug to treat the genetic disorder Fragile X syndrome after getting clearance from U.S. regulators.
The company said the Food and Drug Administration cleared the study under an investigational new drug application for Anavex 2-73, known generically as blarcamesine.
The drug had previously been named an orphan drug by the FDA.
"FDA clearance of the Fragile X IND is an important milestone that gives Anavex open INDs in all three of our core indications: Alzheimer's Disease, Rett syndrome, and Fragile X syndrome, and supports our continued momentum of working closely with the FDA as we move our programs forward," interim Chief Executive Terrie Kellmeyer said.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
October 15, 2026 16:49 ET (20:49 GMT)
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