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Synergy (SGYP) Trulance Wins FDA Approval for Constipation
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Synergy Pharmaceuticals Inc. announced that the FDA has approved one of its lead pipeline candidates, Trulance (plecanatide), for the treatment of adults suffering from chronic idiopathic constipation (CIC). It is expected to hit U.S. market by the end of first-quarter 2017.
Synergy’s share price has gained 70.5% in the past one year, compared with the Zacks classified Medical-Drugs industry’s fall of 10.8%.
The approval was supported by the largest phase III CIC clinical trials which included more than 2,600 patients in two randomized, 12-week, double-blind, placebo-controlled studies on Trulance. Both the studies met the primary endpoint. The studies showed that patients treated with Trulance achieved a significantly greater efficacy responder rate over 12 weeks compared with placebo.
Shares gained during pre-market trading on the news.
As per estimates, CIC affects approximately 33 million people in the U.S. and 14% of the total global population, thereby representing huge market potential for Trulance.
Approval of one of its lead candidates will significantly boost Synergy Pharma’s prospects. However, competition is stiff in the CIC market given the likes of Sucampo Pharmaceuticals’ Amitiza among others.
We note that Synergy Pharma is also evaluating Trulance for the treatment of irritable bowel syndrome with constipation (IBS-C). The company has completed two phase III studies on Trulance for IBS-C and plans to file a supplementary New Drug Application with data (sNDA) later this quarter with an expected 10-month review period from submission.
Zacks Rank & Key Picks
Synergy currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Enzo Biochem, Inc. (ENZ - Free Report) and Sunesis Pharmaceuticals, Inc. . Both Enzo Biochem and Sunesis sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Enzo Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 45% in the past one year.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2017 and 2018, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.
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Synergy (SGYP) Trulance Wins FDA Approval for Constipation
Synergy Pharmaceuticals Inc. announced that the FDA has approved one of its lead pipeline candidates, Trulance (plecanatide), for the treatment of adults suffering from chronic idiopathic constipation (CIC). It is expected to hit U.S. market by the end of first-quarter 2017.
Synergy’s share price has gained 70.5% in the past one year, compared with the Zacks classified Medical-Drugs industry’s fall of 10.8%.
The approval was supported by the largest phase III CIC clinical trials which included more than 2,600 patients in two randomized, 12-week, double-blind, placebo-controlled studies on Trulance. Both the studies met the primary endpoint. The studies showed that patients treated with Trulance achieved a significantly greater efficacy responder rate over 12 weeks compared with placebo.
Shares gained during pre-market trading on the news.
As per estimates, CIC affects approximately 33 million people in the U.S. and 14% of the total global population, thereby representing huge market potential for Trulance.
Approval of one of its lead candidates will significantly boost Synergy Pharma’s prospects. However, competition is stiff in the CIC market given the likes of Sucampo Pharmaceuticals’ Amitiza among others.
We note that Synergy Pharma is also evaluating Trulance for the treatment of irritable bowel syndrome with constipation (IBS-C). The company has completed two phase III studies on Trulance for IBS-C and plans to file a supplementary New Drug Application with data (sNDA) later this quarter with an expected 10-month review period from submission.
Zacks Rank & Key Picks
Synergy currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Enzo Biochem, Inc. (ENZ - Free Report) and Sunesis Pharmaceuticals, Inc. . Both Enzo Biochem and Sunesis sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Enzo Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 45% in the past one year.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2017 and 2018, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.
Synergy Pharmaceuticals Inc. Price
Synergy Pharmaceuticals Inc. Price | Synergy Pharmaceuticals Inc. Quote
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Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>