Synergy Pharma's Plecanitide Finally Crosses The Finish Line; Rodman & Renshaw Lifts Price Target To $18

After market close on January 19, Synergy Pharmaceuticals Inc SGYP reported that it had achieved FDA approval for its lead drug, plecanatide, in constipation-predominant irritable bowel syndrome (IBS-C).

Rodman & Renshaw’s Raghuram Selvaraju reiterated a Buy rating on the company, while raising the price target from $17 to $18.

FDA Approval

“Synergy's flagship product, which we anticipate to be launched later this quarter under the trade name Trulance™, was approved for the treatment of chronic idiopathic constipation (CIC) over a week ahead of the original PDUFA date of January 29, 2017,” the analyst mentioned.

Selvaraju pointed out that in addition to the launch of Trulance™ in the near term, Synergy Pharma also expects to file the supplemental New Drug Application (NDA) for plecanatide in the treatment of IBS-C later during the quarter.

Largest Trial

“Trulance™ could win approval in the IBS-C indication by the end of this year, in our view, given a roughly 10-month review period. We note that the drug demonstrated solid efficacy and safety across four robustly-designed Phase 3 trials in CIC and IBS-C,” the analyst stated.

Trulance™ has been evaluated through the largest Phase 3 trial for CIC to date, with the drug being tested through two randomized, placebo-controlled, double-blind studies with over 2,600 patients.

At last check, Synergy shares were up 4.22 percent at $6.68.