Synergy's (SGYP) Plecanatide Seen as 'Rare Gem' at Roth Capital

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Synergy Pharmaceuticals Announces Acceptance of New Drug Application for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation

April 19, 2016 6:00 AM EDT

PDUFA target action date of January 29, 2017

NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals Inc. (NASDAQ: SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced the U.S. Food and Drug Administration (FDA) has determined that the companys New Drug Application (NDA) for plecanatide, its first uroguanylin analog, for the treatment of chronic idiopathic constipation (CIC) is sufficiently complete to permit a substantive review. The FDA Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.

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