How Adverum Bio Is Winning With FDA Update

Health and Healthcare

Published: September 20, 2018 10:30 am

Last Updated: May 14, 2021 10:32 am

Adverum Biotechnologies Inc. (NASDAQ: ADVM) shares made a handy gain on Thursday after the company announced a key update from the U.S. Food and Drug Administration (FDA).

The FDA granted a Fast Track designation for ADVM-022, for the treatment of wet age-related macular degeneration (wAMD).

A Fast Track Designation is intended to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill unmet medical needs. The designation enables more frequent communication with the FDA throughout a product candidate’s development and review process.

Age-related macular degeneration (AMD) is a progressive disease affecting the retinal cells in the macula, the region of the eye responsible for central vision. Disease progression results in the death of retinal cells and the gradual loss of vision. Approximately 10% of patients living with AMD have an advance form of the of the disease called wAMD, in which blood vessels begin to invade the cellular space between the layers of cells in the retina.

Leone Patterson, interim president and CEO of Adverum, commented:

The FDA’s Fast Track designation is an important recognition of our ADVM-022 gene therapy program. We look forward to working with the FDA and benefiting from the potential expedited development and regulatory path offered by their Fast Track program.

Its shares were last seen up about 4% at $6.11, with a consensus analyst price target of $10.25 and a 52-week trading range of $2.85 to $8.59.

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