Synergy Pharma (SGYP) Announces Filing of Plecanatide NDA with U.S. FDA for Idiopathic Constipation
- Nasdaq hits record high ahead of business activity data
- Bitcoin (BTC) Recovers to $34,000 as Analysts Insists Crypto Winter Won't Repeat Again
- Dollar slips after Fed's Powell downplays inflation fears
- Xpeng (XPEV) Leaps After Receiving a Green Light From Regulators to Raise Up To $2 Billion in Hong Kong IPO
- Cathie Wood's ARK Buys ~$77M in Bitcoin-Related Securities Yesterday on Dip
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Synergy Pharmaceuticals Inc. (Nasdaq: SGYP) announced the company has filed with the U.S. Food and Drug Administration (FDA) its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC).
“The submission of the plecanatide NDA for CIC marks a major milestone for Synergy as we move the product candidate another step closer to potential approval early next year,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals. “I want to thank the Synergy team, our many advisors and my board of directors for their relentless efforts, enthusiasm and commitment in bringing plecanatide, a drug candidate which we invented in-house and developed entirely on our own, to this important milestone. We remain completely focused on flawless execution in 2016, with the ultimate goal of potentially providing patients and their healthcare providers a new treatment option for this very debilitating disease.”
The plecanatide NDA for CIC is supported by positive results from two phase 3 clinical trials which Synergy completed in 2015. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Southwest Airlines (LUV) says Gary Kelly will transition to Executive Chairman in 2022, Robert Jordan will become Kelly's successor as CEO
- ReTo Eco-Solutions (RETO) announces new iron tailings project in Hainan Province
- AIkido Pharma (AIKI) Files Patent Application for the Use of Ketamine to Treat Alzheimer's Disease
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!