Synergy Pharmaceuticals Inc (NASDAQ:SGYP) announced the initiation of the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in patients with irritable bowel syndrome with constipation (IBS-C).
The phase 3 IBS-C program includes two randomized, 12-week, double-blind, placebo-controlled pivotal trials conducted in the United States and each trial is expected to enroll approximately 1050 adult patients with IBS-C. Patients with IBS-C are defined by Rome III Criteria as having a history of constipation and abdominal pain for at least 6 months, including hard or lumpy stools for 25% or more of defecations, loose or watery stools for 25% or less of defecations, and abdominal pain or discomfort for 3 days or more per month for the last 3 months. The primary efficacy endpoint for both trials is the percentage of patients who are Overall Responders during the 12 week treatment period. An Overall Responder, as defined by the FDA, is a patient who is a weekly responder (i.e. meets both the abdominal pain intensity reduction and stool frequency increase criteria in the same week) for at least 6 of the 12 treatment weeks.
Synergy initiated the first phase 3 IBS-C trial in December 2014. The phase 3 IBS-C program was designed to support regulatory submission in the US. (Original Source)
Shares of Synergy Pharmaceuticals closed yesterday at $8.27 . SGYP has a 1-year high of $9.52 and a 1-year low of $2.45. The stock’s 50-day moving average is $4.73 and its 200-day moving average is $3.74.
On the ratings front, Synergy Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on June 17, Cantor Fitzgerald analyst Irina Rivkind Koffler reiterated a Buy rating on SGYP, with a price target of $14, which represents a potential upside of 69.3% from where the stock is currently trading. Separately, on the same day, Canaccord Genuity’s Corey Davis maintained 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, Irina Rivkind Koffler and Corey Davis have a total average return of 51.7% and 19.5% respectively. Koffler has a success rate of 68.0% and is ranked #3 out of 3640 analysts, while Davis has a success rate of 62.5% and is ranked #201.
Synergy Pharmaceuticals Inc is a biopharmaceutical company. It engages in the development of drugs to treat gastrointestinal, or GI, disorders and diseases.