Synergy's Incoming FDA Catalyst

Timothy Chiang of BTIG remains Buy-rated on Synergy Pharmaceuticals Inc SGYP ahead of the company's Phase 3 data for plecanatide in patients with constipation predominant IBS. A release of top line results from its two pivotal Phase 3 IBS-C trials is expected before year end.

Plecanatide is being studied for gastro intestinal diseases chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).

If positive, the analyst expects a sNDA filing in the first quarter of 2017. In addition, an FDA approval decision for plecanatide (for the treatment of chronic constipation) is expected by Jan. 29, 2017.

Chiang believes an approval for the CIC indication is likely, based on his review of Phase 3 data.

“We believe Synergy’s plecanatide (once-daily tablet for the treatment of CIC and IBS-C) has the potential to become a meaningful new product with sales potential in excess of $400M by 2020,” Chiang wrote in a note.

At last check, shares of Synergy rose 3.96 percent to $5.51. The analyst has a price target of $11, implying a potential upside of 100 percent from current levels.