Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) Files An 8-K Other EventsItem 8.01 Other Events.
On June 7, 2017, Synergy Pharmaceuticals Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for TRULANCE™ (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). The Prescription Drug User Fee Act (PDUFA) date is January 24, 2018. The press release is attached as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Synergy Pharmaceuticals Inc. Press Release dated June 7, 2017.
About Synergy Pharmaceuticals Inc. (NASDAQ:SGYP)
Synergy Pharmaceuticals Inc. (Synergy) is a biopharmaceutical company focused on the development and commercialization of gastrointestinal (GI) therapies. The Company’s GI platform includes two lead product candidates: plecanatide and dolcanatide. It is engaged in the discovery, research and development involving uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease. Plecanatide is the Company’s uroguanylin analog being evaluated for use as a once-daily tablet for two functional GI disorders, chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with the exception of a single amino acid change. Dolcanatide is also its uroguanylin analog being explored for inflammatory bowel disease (IBD). Dolcanatide is designed to be an analog of uroguanylin with resistance to standard digestive breakdown by proteases in the intestine.
