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Last $9.10 USD
Change Today +0.80 / 9.64%
Volume 8.4M
SGYP On Other Exchanges
As of 8:10 PM 07/1/15 All times are local (Market data is delayed by at least 15 minutes).

synergy pharmaceuticals inc (SGYP) Snapshot

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synergy pharmaceuticals inc (SGYP) Details

Synergy Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development of drugs to treat gastrointestinal (GI) disorders and diseases. Its lead product candidate is plecanatide, a guanylyl cyclase C receptor agonist that is in Phase III clinical trials to treat chronic idiopathic constipation GI disorders; and for the treatment of constipation-predominant irritable bowel syndrome GI disorders. The company is also developing SP-333, which is in Phase II clinical trials to treat opioid induced constipation, as well as in Phase Ib clinical trials to treat ulcerative colitis. Synergy Pharmaceuticals Inc. is headquartered in New York, New York.

35 Employees
Last Reported Date: 03/16/15

synergy pharmaceuticals inc (SGYP) Top Compensated Officers

Chairman, Chief Executive Officer and Preside...
Total Annual Compensation: $750.0K
Principal Financial Officer, Principal Accoun...
Total Annual Compensation: $276.0K
Chief Medical Officer and Executive Director
Total Annual Compensation: $445.3K
Chief Scientific Officer
Total Annual Compensation: $392.0K
Compensation as of Fiscal Year 2014.

synergy pharmaceuticals inc (SGYP) Key Developments

Synergy Pharmaceuticals, Inc. Appoints Timothy Callahan and Richard Daly as New Independent Directors

Synergy Pharmaceuticals Inc. announced that it has appointed Timothy Callahan and Richard Daly as new independent directors to its board. Both Mr. Callahan and Mr. Daly have direct experience in primary care and gastrointestinal markets and have led large organizational change and successful business growth, in a variety of areas, including all aspects of commercial, acquisitions, partnerships and product launches. Mr. Callahan is a global life sciences business leader with over 21 years of experience in pharmaceutical and biologic commercialization, most recently with the Actavis organization. Mr. Daly has over 20 years of commercial pharmaceutical experience working in positions of progressive responsibility in sales, marketing and operations. Recently, Mr. Daly was the President of U.S. Diabetes for the joint alliance between Bristol-Myers Squibb and AstraZeneca.

Synergy Pharmaceuticals Inc. Announces Initiation of Second of Two Pivotal Phase 3 Clinical Trials

Synergy Pharmaceuticals Inc. announced the initiation of 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 patients with irritable bowel syndrome with constipation (IBS-C). The 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 approximately 1,050 adult patients with IBS-C. Patients with IBS-C are defined by Rome III Criteria as having a history of constipation and abdominal pain for at least 6 months, including hard or lumpy stools for 25% or more of defecations, loose or watery stools for 25% or less of defecations, and abdominal pain or discomfort for 3 days or more per month for the last 3 months. The primary efficacy endpoint for both trials is the percentage of patients who are Overall Responders during the 12 week treatment period. An Overall Responder, as defined by the FDA, is a patient who is a weekly responder (i.e. meets both the abdominal pain intensity reduction and stool frequency increase criteria in the same week) for at least 6 of the 12 treatment weeks. The company initiated the first phase 3 IBS-C trial in December 2014. The phase 3 IBS-C program was designed to support regulatory submission in the US.

Synergy Pharmaceuticals Inc. Announces Positive Results in the First Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation

Synergy Pharmaceuticals Inc. announced positive results from the first 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 1,346 adult patients with chronic idiopathic constipation (CIC). Preliminary analysis of the data indicates that both plecanatide 3.0 mg and 6.0 mg doses met the study’s primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (21.0% in 3.0 mg and 19.5% in 6.0 mg dose groups compared to 10.2% in placebo; pThe Plecanatide Phase 3 CIC Program. Design: The plecanatide phase 3 CIC program includes two randomized, 12-week, double-blind, placebo-controlled pivotal 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 patients with CIC. Both trials include a two-week pre-treatment baseline period, a 12-week treatment period, and a two-week post-treatment period. The phase 3 CIC program was designed to support regulatory submission in the U.S. The first phase 3 CIC trial was conducted in North America and assessed 1,346 adult patients (19.2% males and 80.8% females) that were randomly assigned to take 3.0 mg or 6.0 mg plecanatide or placebo once-a-day during the 12 week treatment period (453 patients in the 3 mg dose group, 441 patients in the 6.0 mg dose group and 452 patients in the placebo group). Primary Endpoint: The primary endpoint for both trials is the proportion of durable overall responders (%), which is the current regulatory endpoint required for U.S. approval in CIC. The FDA has defined a durable overall responder as a patient who fulfills both = 3 complete spontaneous bowel movements (CSBMs) per week plus an increase of = 1 CSBM from baseline in the same week, for 9 out of the 12 treatment weeks. In addition, the same patient must be an overall responder for at least 3 of the last 4 treatment weeks in order to be considered a durable overall responder. Patient Population: Patients were selected using Rome 3 criteria modified for CIC and had fewer than 3 defecations per week, loose stools occurring rarely without laxatives, inadequate criteria for irritable bowel syndrome with constipation (IBS-C), and at least two of the following applied to at least 25% of defecations: straining during evacuation, lumpy or hard stools, sensation of anorectal obstruction or blockage. Rome 3 requires patients to fulfill the criteria for the last 3 months with symptom onset at least 6 months prior to diagnosis.


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