Synergy Reports Positive Phase 3-Trial 1 Data

Before Friday's market open, Synergy Pharmaceuticals Inc SGYP announced positive data from its first of two Phase 3 trials for clinical constipation-predominant irritable bowel syndrome (IBS-C) drug plecanatide.

“We are very pleased with these results,” said Gary S. Jacob, Ph.D., chairman and CEO of Synergy. “These data reinforce our strong belief that plecanatide may represent an important new treatment option for the millions of patients currently suffering from IBS-C. We look forward to the results of our second phase 3 IBS-C trial with plecanatide later this month.”

If the second Phase 3 results show positive data as well, an NDA should be filed in Q1 2017, and the FDA should be expected to make a decision by January 29, 2017, according to BTIG analyst Timothy Chiang.

At last check, shares of Synergy were trading up 17 percent in the pre-market session.