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Synergy Pharmaceuticals Inc (SGYP.O)

SGYP.O on Nasdaq

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21 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Synergy Pharmaceuticals says positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation
Thursday, 22 Dec 2016 04:30pm EST 

Synergy Pharmaceuticals Inc : Synergy Pharmaceuticals announces positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation (ibs-c) . Synergy Pharmaceuticals Inc - plecanatide is under review by food and drug administration (fda) for treatment of chronic idiopathic constipation . Synergy Pharmaceuticals - most common adverse event was diarrhea which occurred in 5.4 pct of patients in 3 mg and 4.3% of patients in 6 mg dose groups . Synergy Pharmaceuticals Inc - overall responder endpoint is current regulatory endpoint required for U.S. approval in ibs-c . Preliminary analysis of data indicates that both plecanatide 3 mg and 6 mg doses met study's primary endpoint . Synergy Pharmaceuticals- pending approval in cic indication,plans to file new drug application supplement with clinical data for plecanatide in ibs-c in q1 2017 . Synergy Pharmaceuticals Inc - prescription drug user fee act (pdufa) target action date for plecanatide is January 29, 2017 . Synergy Pharmaceuticals says it plans to present further clinical data from both trials at an appropriate scientific meeting next year .Synergy Pharmaceuticals announces positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation (ibs-c).  Full Article

Synergy Pharma enters privately-negotiated exchange agreements
Monday, 21 Nov 2016 05:19pm EST 

Synergy Pharmaceuticals Inc : Synergy Pharma-co entered privately-negotiated exchange agreements with certain holders of co's 7.50% convertible senior notes due 2019 . Synergy Pharmaceuticals-holders agreed to exchange aggregate amount of about $20.7 million of notes, accrued but unpaid interest under notes held by them .Synergy Pharmaceuticals-holders agreed to exchange total principal amount of $20.7 million in exchange for 7.6 million shares of co's common stock-sec filing.  Full Article

Synergy Pharma Q2 net loss $38.6 million
Monday, 8 Aug 2016 05:00pm EDT 

Synergy Pharmaceuticals Inc : Synergy pharmaceuticals reports second quarter 2016 financial results and business update .Net loss in q2 of 2016 was $38.6 million, as compared to a net loss of $33.7 million incurred in q2 of 2015.  Full Article

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