By Chris Wack

 

Iveric bio Inc. shares were up 16% to $23.20 after the company said the U.S. Food and Drug Administration completed its filing review and accepted its new drug application for avacincaptad pegol.

Avacincaptad pegol is a novel investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to age-related macular degeneration, according to Iveric.

The Parsippany, N.J.-based biopharmaceutical company said the new drug application has been granted a priority review with a Prescription Drug User Fee Act goal date of Aug. 19, 2023. The company also said that, at this time, the FDA hasn't identified any potential review issues and planned to hold an advisory committee meeting for the drug.

The new drug application was submitted based on 12-month pre-specified primary efficacy and safety results.

Iveric bio shares hit their 52-week high of $24.56 on Feb. 2, and are up 59% over the past 12 months.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

February 17, 2023 10:39 ET (15:39 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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