Synergy Pharmaceuticals Inc (NASDAQ:SGYP) announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Additionally, the company is providing an update on the ongoing irritable bowel syndrome with constipation (IBS-C) program.
“We are pleased with the progress and ongoing dialogue with the FDA,” said Gary S. Jacob, Chairman and CEO of Synergy Pharmaceuticals, “We remain optimistic about the potential approval of plecanatide in CIC by the PDUFA date of January 29, 2017. I am also very pleased with the progress our commercial, medical affairs and supply chain teams have made in recent months as we anticipate bringing this important new treatment option to CIC patients and their caregivers early next year.”
Furthermore, the company has decided to continue patient enrollment for its two ongoing phase 3 clinical trials with plecanatide in IBS-C. The decision to continue enrollment comes after trial monitoring demonstrated a slower enrollment pace combined with an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment.
“Our first priority is to ensure high quality trials that reflect our rigorous standards and expectations,” said Dr. Jacob, “To that end, we are updating our timing for top-line data in both trials to the fourth quarter of this year and intend to file the plecanatide NDA in IBS-C in the first quarter of 2017. We remain confident that plecanatide will continue to deliver outstanding clinical results consistent with previous trials, ultimately providing an important treatment option for patients suffering from IBS-C.” (Original Source)
Shares of Synergy Pharmaceuticals are down nearly 8% to $3.52 in early trading Friday. SGYP has a 1-year high of $9.76 and a 1-year low of $2.50. The stock’s 50-day moving average is $3.81 and its 200-day moving average is $3.60.
On the ratings front, SGYP has been the subject of a number of recent research reports. In a report issued on July 11, Rodman & Renshaw analyst Ram Selvaraju reiterated a Buy rating on SGYP, with a price target of $15, which implies an upside of 291.6% from current levels. Separately, on May 25, Roth Capital’s Michael Higgins reiterated a Buy rating on the stock and has a price target of $6.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Michael Higgins have a total average return of -0.2% and -15.2% respectively. Selvaraju has a success rate of 39% and is ranked #2823 out of 3973 analysts, while Higgins has a success rate of 28% and is ranked #3861.
The street is mostly Bullish on SGYP stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $11.00, which represents a potential upside of 187.2% from where the stock is currently trading.
Synergy Pharmaceuticals, Inc. is a biopharmaceutical company, which focuses on the development of drugs to treat gastrointestinal disorders and diseases. Its lead product candidate includes plecanatide a phase 3 guanylate cyclase C, or GC-C, receptor agonist, designed to treat GI disorders, primarily chronic idiopathic constipation, or CIC, and constipation-predominant irritable bowel syndrome, or IBS-C. CIC and IBS-C are functional gastrointestinal disorders that afflict millions of individuals worldwide.