Shares of Synergy Pharmaceuticals Inc (NASDAQ:SGYP) jumped 1.10% to reach at $4.61 during the course of session. The company has experienced volume of 4.72M shares while on average the company has a capacity of trading 2.55M shares.
Synergy Pharmaceuticals Inc (NASDAQ:SGYP) on August 8, 2016 reported its financial results and business update for the three months ended June 30, 2016.
Second Quarter 2016 and Recent Highlights
Research & Development
Plecanatide CIC Development Update
- The Food and Drug Administration (FDA) has completed its mid-cycle review meeting of the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). To date, no significant issues have been identified. Additionally, the FDA informed us that at this time there are no plans for an advisory committee meeting in connection with its review of the plecanatide NDA in CIC. The plecanatide NDA in CIC is supported by two double-blind placebo-controlled phase 3 trials and one open-label long term safety study. Over 3,500 patients were exposed to plecanatide in the CIC clinical development program. The Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.
- In May 2016, we presented additional plecanatide data, including one oral presentation and five posters, at Digestive Disease Week (DDW) 2016. Data presented at DDW showed that plecanatide met the primary and secondary endpoints in two phase 3 CIC clinical trials. In both trials, plecanatide significantly improved durable overall complete spontaneous bowel movement (CSBM) responder rates relative to placebo (primary endpoint). Plecanatide-treated patients also showed immediate and sustained improvements that were statistically significant in CSBM and SBM frequency and stool consistency scores compared to placebo. Furthermore, plecanatide showed statistically significant improvement in abdominal symptoms, such as straining and bloating, as well as constipation severity and treatment satisfaction scores compared to placebo. Most adverse events were mild to moderate in severity; the most common adverse event was diarrhea (<6.0% diarrhea rates in both trials). In addition to the plecanatide CIC clinical data, we presented new in vitro data showing that the pH-dependent activity of plecanatide replicates that of the body’s naturally occurring GI peptide, uroguanylin.
Commercial Planning & Launch Preparation
Our commercial, medical affairs and technical operations teams are continuing to execute on our key strategic imperatives to ensure launch readiness, including the following major initiatives:
- Ensuring a robust supply chain process for launch and throughout plecanatide’s life-cycle
- Building sufficient trade and sample stock for launch in early 2017
- Implementing our 3PL distribution network
- Developing and implementing strong Quality Management Systems
Synergy Pharmaceuticals Inc (NASDAQ:SGYP) holds the market capitalization of $895.54M along with 179.78M outstanding shares. The stock traded in the price range of $4.41 – $4.86 for the last trading session. For the stock, price target value has been calculated at $9.90 based on calls of 5 experts. Stock’s minimum price target estimates has been figured out at $4.00 while the maximum price target forecast is established at $15.00.
As of current trade, Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has shown weekly upbeat performance of 11.62%. Its six months performance indicated a bullish movement while its yearly performance reflected a negative trend of -42.59%. Year-to-date (YTD) performance of the stock illustrate downbeat trend of -18.69%. Shares of Synergy Pharmaceuticals Inc (NASDAQ:SGYP) currently have an ABR of 1.00, derived from a total of 2 opinions. The company’s price sits 19.02% above from its 50-day moving average of $3.93 and 9.62% above from the stock’s 200-day moving average of $3.52. The company has Relative Strength Index (RSI 14) of 71.54 along with Average True Range (ATR 14) of 0.21. Its weekly and monthly volatility is 6.96%, 5.24% respectively. The company’s beta value is at 1.56.
Synergy Pharmaceuticals Inc (NASDAQ:SGYP)’s price to cash per share for the most recent quarter is 9.59. Synergy Pharmaceuticals Inc (NASDAQ:SGYP)’s quick ratio for most recent quarter is 4.50 along with current ratio for most recent quarter of 4.50. Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has a Return on Assets of -117.00%. The company currently has a Return on Equity of 542.10%.