Shares of Synergy Pharmaceuticals Inc (NASDAQ:SGYP) ended Thursday session in red amid volatile trading. The shares closed down -0.01 points or -0.18% at $5.55 with 3.71 million shares getting traded. Post opening the session at $5.70, the shares hit an intraday low of $5.53 and an intraday high of $5.70 and the price vacillated in this range throughout the day. The company has a market cap of $995.93 million and the numbers of outstanding shares have been calculated to be 179.45 million shares.
Synergy Pharmaceuticals Inc (SGYP) on August 9, 2016 reported its financial results and business update for the three months ended June 30, 2016.
“Our exciting transformation from a purely research and development company into a fully integrated commercial organization continues unabated as we successfully advance and execute against our key strategic priorities,” said Gary S. Jacob, Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc. “These priorities are guided by our overarching mission to optimize the value of plecanatide and maximize shareholder value.”
“The rest of 2016 promises to be an exciting time as we expect top-line results in our two phase 3 IBS-C trials with plecanatide. We are especially pleased with our ongoing dialogue with the FDA, including the results of our recent mid-cycle review meeting. Building the right commercial strategy and having the ability to successfully execute on the launch plan requires a strong team and we are fortunate to be attracting talented leaders with relevant experience from across our industry. I am very proud of the Synergy organization which is committed to a successful launch of plecanatide and bringing this important new treatment option to patients suffering from CIC and IBS-C,” added Dr. Jacob.
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.
Shares of Gilead Sciences, Inc. (NASDAQ:GILD) ended Thursday session in green amid volatile trading. The shares closed up +2.79 points or 3.53% at $81.78 with 17.56 million shares getting traded. Post opening the session at $79.64, the shares hit an intraday low of $79.63 and an intraday high of $82.07 and the price vacillated in this range throughout the day. The company has a market cap of $108.18 billion and the numbers of outstanding shares have been calculated to be 1.32 billion shares.
Gilead Sciences, Inc. (GILD) on August 23, 2016 announced that Kelly A. Kramer has been appointed to the company’s Board of Directors and Audit Committee.
Ms. Kramer is currently Executive Vice President and Chief Financial Officer of Cisco Systems, Inc., which designs and sells products, services and solutions to securely connect everyone and everything. She previously served for 20 years in senior finance positions at General Electric, including as Chief Financial Officer of GE Healthcare’s Healthcare Systems Business. She is a member of the board of the Silicon Valley Chapter of City Year, a non-profit organization that provides educational support for at-risk students in poor communities.
“We are very pleased to welcome Kelly Kramer to the Board of Directors of Gilead Sciences,” said John Martin, PhD, Executive Chairman of Gilead’s Board of Directors. “Kelly’s deep financial expertise in the technology and healthcare industries, including mergers and acquisitions, will be valuable as Gilead continues to grow across multiple therapeutic areas and around the world. I look forward to the contributions and insights that she will bring to the Board.”