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Synergy Pharmaceuticals Inc (SGYP.O)

SGYP.O on Nasdaq

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26 May 2017
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Latest Key Developments (Source: Significant Developments)

Synergy Pharma updates on FDA review clinical development program
Friday, 15 Jul 2016 09:00am EDT 

Synergy Pharmaceuticals Inc : Provides update on ongoing FDA review Of Plecanatide CIC NDA and IBS-C clinical development program . Provides update on ongoing FDA review of Plecanatide CIC NDA and IBS-C clinical development program . Company has decided to continue patient enrollment for its two ongoing phase 3 clinical trials with Plecanatide in IBS-C .Intend to file Plecanatide NDA in IBS-Cin Q1 of 2017.  Full Article

Synergy Pharmaceuticals reports Q1 loss per share $0.51
Tuesday, 10 May 2016 04:30pm EDT 

Synergy Pharmaceuticals Inc : Synergy Pharmaceuticals reports first quarter 2016 financial results and business update . Q1 loss per share $0.51 .Q1 earnings per share view $-0.23 -- Thomson Reuters I/B/E/S.  Full Article

Synergy Pharmaceuticals Inc announces $89.8 million registered direct offering of common stock
Thursday, 5 May 2016 08:00am EDT 

Synergy Pharmaceuticals Inc:Entered into definitive agreements with certain institutional investors to sell 29,948,334 shares of common stock at a price of $3.00 per share.Offering is expected to close on or about May 6, 2016.Intends to use net proceeds to fund its commercialization activities for plecanatide, further clinical development of plecanatide and dolcanatide and for working capital and other general corporate purposes.  Full Article

Synergy Pharmaceuticals Inc files new drug application for plecanatide in chronic idiopathic constipation
Friday, 29 Jan 2016 11:57am EST 

Synergy Pharmaceuticals Inc:Files new drug application for plecanatide in chronic idiopathic constipation.Says if approved, Synergy plans to launch plecanatide with the cic indication in the first quarter of 2017.Plecanatide nda for cic is supported by positive results from two phase 3 clinical trials which Synergy completed in 2015.  Full Article

Synergy Pharmaceuticals Inc announces positive trial results with dolcanatide in patients with ulcerative colitis
Monday, 11 Jan 2016 06:00am EST 

Synergy Pharmaceuticals Inc:Announces positive trial results with dolcanatide in patients with ulcerative colitis, confirming the role of uroguanylin in inflammatory bowel disease.Says dolcanatide was also safe and well tolerated.Says analysis of the data indicates clear signals of improvement in dolcanatide-treated patients.  Full Article

Synergy Pharmaceuticals announces positive results in the second phase 3 trial of plecanatide in patients with chronic idiopathic constipation
Thursday, 30 Jul 2015 06:00am EDT 

Synergy Pharmaceuticals Inc:Announces positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1337 adult patients with chronic idiopathic constipation (CIC).  Full Article

Synergy Pharmaceuticals Inc initiates second phase 3 clinical trial of plecanatide
Tuesday, 23 Jun 2015 06:00am EDT 

Synergy Pharmaceuticals Inc:Says initiation of second of two pivotal phase 3 clinical trials evaluating efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in patients with irritable bowel syndrome with constipation (IBS-C).Says phase 3 IBS-C program includes two randomized, 12-week, double-blind, placebo-controlled pivotal trials conducted in the United States and each trial is expected to enroll about 1050 adult patients with IBS-C.Primary efficacy endpoint for both trials is the percentage of patients who are Overall Responders during the 12 week treatment period.Says an Overall Responder, as defined by the FDA, is a patient who is a weekly responder for at least 6 of the 12 treatment weeks.  Full Article

Synergy Pharmaceuticals announces positive results in the first phase 3 trial of plecanatide in patients with chronic idiopathic constipation
Wednesday, 17 Jun 2015 06:00am EDT 

Synergy Pharmaceuticals Inc:Announces positive results in the first phase 3 trial of plecanatide in patients with chronic idiopathic constipation (cic).Says 15 patients in the trial (1.1 pct.) experienced serious adverse events.Data indicates that both plecanatide 3.0 mg and 6.0 mg doses met the study's primary endpoint.Plans to file its first new drug application (NDA) with plecanatide in the cic indication in the fourth quarter of this year.Says plans to announce top-line data results from the second phase 3 cic trial with plecanatide in the first half of Q3 2015.Plecanatide 3.0 mg and 6.0 mg showed statistical significance in proportion of patients in the intention-to-treat population.  Full Article

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BRIEF-Synergy Pharmaceuticals reports Q1 sales $100,000

* Synergy Pharmaceuticals reports first quarter 2017 financial results and business update