Shares of Synergy Pharmaceuticals Inc (NASDAQ:SGYP) ended Thursday session in red amid volatile trading. The shares closed down -0.05 points or -0.89% at $5.58 with 2.91 million shares getting traded. Post opening the session at $5.65, the shares hit an intraday low of $5.48 and an intraday high of $5.74 and the price vacillated in this range throughout the day. The company has a market cap of $1.02 billion 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.
Plecanatide IBS-C Development Update
- We have completed over 95% of planned patient enrollment in our two phase 3 irritable bowel syndrome with constipation (IBS-C) clinical trials with plecanatide and we expect top-line data in both trials in the fourth quarter of this year. The two double-blind placebo-controlled trials are designed to enroll a total of approximately 2,100 IBS-C patients. The primary endpoint being evaluated in these 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 a 30% abdominal pain intensity reduction and stool frequency increase criteria in the same week) for at least 6 of the 12 treatment weeks. Plecanatide previously met this endpoint in a phase 2b trial with 424 IBS-C patients that was completed in 2014.
Dolcanatide UC Development Update
- Earlier this year, we announced positive proof-of-concept in a phase 1b double-blind placebo-controlled four-week trial evaluating dolcanatide treatment in 28 patients with mild-to-moderate ulcerative colitis. We intend to announce next steps for the dolcanatide phase 2 clinical program in patients with mild-to-moderate ulcerative colitis following agreement on the development plans with regulators.
Shares of Medivation Inc (NASDAQ:MDVN) ended Thursday session in green amid volatile trading. The shares closed up +0.05 points or 0.06% at $81.08 with 2.76 million shares getting traded. Post opening the session at $81.03, the shares hit an intraday low of $80.94 and an intraday high of $81.10 and the price vacillated in this range throughout the day. The company has a market cap of $13.48 billion and the numbers of outstanding shares have been calculated to be 165.93 million shares.
Medivation Inc (MDVN) is a biopharmaceutical company. The Company is focused on the development and commercialization of therapies to treat serious diseases for which there are limited treatment options. The Company, in collaboration with Astellas Pharma, Inc. (Astellas), has one commercial product, XTANDI (enzalutamide) capsules (XTANDI). XTANDI has received marketing approval in the United States, Europe and other countries across the world for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and in Japan for the treatment of patients with castration-resistant prostate cancer (CRPC). The Company, in collaboration with Astellas, is also conducting investigational studies of enzalutamide in prostate cancer and in advanced breast cancer. It has developed a small molecule inhibitor of the sterol regulatory element-binding protein, or SREBP, pathway which it refers to as MDV4463.