Synergy Pharma Reports Long-Term Data On Plecanatide In Chronic Idiopathic Constipatio
Synergy Pharmaceuticals Inc (NASDAQ: SGYP) presented long-term data on safety of plecanatide. The FDA is currently assessing the investigational, orally-administered compound for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treatment.
The company indicated the data demonstrated that plecanatide was associated with low adverse events and low discontinuation rates in CIC patients, who got the drug for a maximum of 72 weeks once a day.
Synergy Pharmaceuticals' EVP and Chief Medical Officer, Patrick Griffin, commented, "We are excited to bring these new data to gastroenterologists at ACG. We are committed to developing and bringing to market novel therapies that offer the potential to significantly improve the lives of patients living with CIC and other GI conditions."
The company disclosed that Prescription Drug User Fee Act (PDUFA) target action date is set for January 29 for plecanatide.
Additionally, the company completed patient enrolment for the two double-blind, placebo-controlled third stage clinical studies with plecanatide in IBS-C, which remains on track to announce data in the fourth quarter.
Synergy traded up by $0.19, or 3.68 percent, to $5.35 in pre-market trading, although it began to sell off as the opening bell approached.
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