Synergy Pharma remains optimistic over FDA approval of plecanatide for CIC in early 2017, patient enrollment extended in IBS-C studies; shares off 8% premarket
Jul. 15, 2016 9:17 AM • SA Editor Douglas W. House
Based on its ongoing dialogue with the FDA and the achievement of its mid-cycle review milestone, Synergy Pharmaceuticals (NASDAQ:SGYP) maintains its optimism that lead product candidate plecanatide will be approved to treat chronic ideopathic constipation (CIC) by its January 29, 2017 PDUFA date.
In addition, it will continue patient enrollment in its two current Phase 3 clinical trials assessing plecanatide in irritable bowel syndrome with constipation (IBS-C). The decision was made after trial monitoring showed a slower enrollment pace and an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment.
Shares are down 8% premarket on average volume.
