Synergy Pharmaceuticals Inc (NASDAQ:SGYP) announced the company has filed with the U.S. Food and Drug Administration (FDA) its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC).
“The submission of the plecanatide NDA for CIC marks a major milestone for Synergy as we move the product candidate another step closer to potential approval early next year,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals. “I want to thank the Synergy team, our many advisors and my board of directors for their relentless efforts, enthusiasm and commitment in bringing plecanatide, a drug candidate which we invented in-house and developed entirely on our own, to this important milestone. We remain completely focused on flawless execution in 2016, with the ultimate goal of potentially providing patients and their healthcare providers a new treatment option for this very debilitating disease.”
The plecanatide NDA for CIC is supported by positive results from two phase 3 clinical trials which Synergy completed in 2015. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017. (Original Source)
Shares of Synergy Pharmaceuticals are trading at $3.71, up $0.13 or 3.63%. SGYP has a 1-year high of $10.15 and a 1-year low of $2.84. The stock’s 50-day moving average is $4.95 and its 200-day moving average is $6.45.
On the ratings front, Synergy has been the subject of a number of recent research reports. In a report issued on January 25, Rodman & Renshaw analyst Ram Selvaraju reiterated a Buy rating on SGYP, with a price target of $20, which implies an upside of 455.6% from current levels. Separately, on November 12, Canaccord Genuity’s Corey Davis reiterated a Buy rating on the stock and has a price target of $19.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Corey Davis have a total average return of -0.2% and 0.7% respectively. Selvaraju has a success rate of 41.1% and is ranked #2100 out of 3594 analysts, while Davis has a success rate of 36.6% and is ranked #1393.
Synergy Pharmaceuticals Inc is a biopharmaceutical company. It engages in the development of drugs to treat gastrointestinal, or GI, disorders and diseases.