ISEE - IVERIC bio stock +7% after FDA accepts NDA for Avacincaptad Pegol
- IVERIC bio ( NASDAQ: ISEE ) on Thursday said the U.S. Food and Drug Administration has completed its filing review and accepted the company’s new drug application for Avacincaptad Pegol.
- Shares +7.5% at $21.50 after hours.
- The NDA has been granted priority review with a PDUFA goal date of August 19, 2023.
- The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.
- Avacincaptad Pegol is the company's novel investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to age-related macular degeneration.
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IVERIC bio stock +7% after FDA accepts NDA for Avacincaptad Pegol