Synergy Pharmaceuticals Inc fka SGYPQ

[Snackman]

Two Key FDA Decisions to Watch Out for in January 2017
New York-based Synergy Pharmaceuticals Inc. SGYP, which is focused on the development and commercialization of novel gastrointestinal (GI) therapies, has an important regulatory event coming up towards the end of this month with the FDA expected to decide on the approval status of one of the company’s lead pipeline candidates – plecanatide.

The company is looking to get the product approved for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. FDA approval would be a transforming event for the company which currently has no approved products in its portfolio. Synergy, a Zacks Rank #3 (Hold) stock, had a good run in 2016 with the company gaining 13.4% compared to a 23% decline for the Zacks-categorized Medical-Drugs industry. The company, in fact, ended 2016 on a positive note with impressive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017. The market opportunity is huge considering about 45 million adults in the U.S. suffer from CIC/IBS-C with the market expected to grow at double digit rates on the back of increased treatment options, market education, an aging population and awareness of gut health.



http://finance.yahoo.com/news/two-key-fda-decisions-watch-134101183.html