Annovis Bio Inc (ANVS)

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Annovis Bio files for FDA orphan drug designation for ANVS401, shares rise

May 13, 2021

)By: Aakash Babu

Annovis Bio (NYSE:ANVS) announces that it has filed an application with the U.S. FDA to receive orphan drug designation for its lead drug candidate, ANVS401, for the treatment of Alzheimer's disease (AD) in persons with Down syndrome (DS).

Shares up nearly 8% premarket.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

The special status would qualify ANVS401 for certain benefits and incentives, including seven years of marketing exclusivity, once it gets regulatory approval.

DS occurs in about 1 in 700 newborns and about 200K people in the U.S. have the condition. People with DS often experience a gradual decline in cognition as they age, which can lead to AD.

Annovis had announced positive results of an interim analysis from study of ANVS401, in March.