Shares of Aerie Pharmaceuticals Inc (NASDAQ:AERI) ended Friday session in green amid volatile trading. The shares closed up +4.26 points or 13.92% at $34.87 with 10.25 million shares getting traded. Post opening the session at $31.01, the shares hit an intraday low of $30.90 and an intraday high of $35.25 and the price vacillated in this range throughout the day. The company has a market cap of $1.11 billion and the numbers of outstanding shares have been calculated to be 27.89 million shares.
Aerie Pharmaceuticals Inc (AERI) on September 16, 2016 announced the pricing of a registered underwritten public offering of $75 million of shares of its common stock at a price to the public of $29.50 per share, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering was upsized by $25 million over the offering amount anticipated to be sold as previously announced. This is in addition to $50 million raised separately through the completion and full utilization of an at-the-market (ATM) program with Cantor Fitzgerald & Co. filed prior to market open on September 15, 2016. Total gross proceeds raised through these offerings were $125 million. The shares sold through the $50 million ATM program will be issued on or about September 20, 2016, and the $75 million public offering is expected to close on or about September 21, 2016, subject to the satisfaction of customary closing conditions.
Shares of Synergy Pharmaceuticals Inc (NASDAQ:SGYP) ended Friday session in red amid volatile trading. The shares closed down -0.27 points or -4.63% at $5.56 with 9.80 million shares getting traded. Post opening the session at $5.90, the shares hit an intraday low of $5.45 and an intraday high of $5.90 and the price vacillated in this range throughout the day. The company has a market cap of $951.52 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 business update for the three months ended June 30, 2016.
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.
“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.”