On Friday, Shares of Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP), lost -1.09% to $9.07.
Synergy Pharmaceuticals, declared positive top-line 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 contrast to placebo during the 12-week treatment period (21.0% in 3.0 mg and 19.5% in 6.0 mg dose groups contrast to 10.2% in placebo; p<0.001 for both doses). The durable overall responder endpoint is the current FDA endpoint required for US approval in CIC. Plecanatide would be the first drug approved for CIC using the more stringent regulatory requirement for durability in the response. Notably, plecanatide was safe and well tolerated at both doses; the most common adverse event was diarrhea, which occurred in 5.9% of patients in 3.0 mg and 5.5% of patients in 6.0 mg dose groups contrast to 1.3% of placebo-treated patients.
Stool consistency was the key secondary endpoint stated with top-line analyses; both 3.0 mg and 6.0 mg plecanatide doses showed statistically noteworthy improvement from baseline in Bristol Stool Form Scale (BSFS) scores contrast to placebo (mean enhance of 1.53 in 3.0 mg and 1.52 in 6.0 mg dose groups contrast to a mean enhance of 0.77 in placebo; p<0.001 for both doses). The observed improvements began at Week 1, continued throughout the 12-week treatment period, and returned towards baseline with no indication of an exaggerated or rebound effect following discontinuation of treatment.
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.
Shares of Huntington Bancshares Incorporated (NASDAQ:HBAN), declined -1.30% to $11.36, during its last trading session.
Huntington Bancshares Incorporated, anticipates to report its second quarter earnings on Thursday, July 23, 2015, preceding to the market opening.
Conference Call / Webcast Information
Huntington’s senior administration will host an earnings conference call the same day at 10:00 a.m. (Eastern Daylight Time). The call, together with slides, may be accessed via a live Internet webcast at www.huntington-ir.com or through a dial-in telephone number at (844) 318-8148; conference ID #11113310.
Huntington Bancshares Incorporated operates as a holding company for The Huntington National Bank that provides commercial, small business, consumer, and mortgage banking services. The company’s Retail and Business Banking segment offers financial products and services, counting checking accounts, savings accounts, money market accounts, certificates of deposit, consumer loans, and small business loans; and investments, insurance, interest rate risk protection, foreign exchange hedging, and treasury administration services.
Finally, Medtronic plc (NYSE:MDT), ended its last trade with -0.01% loss, and closed at $76.71.
Selected for nearly one of every two endovascular abdominal aortic aneurysm (AAA) repairs globally, the Endurant AAA stent graft system from Medtronic plc, maintained durable, consistent and proven outcomes through five years of follow-up in the company`s U.S. clinical study of the implantable medical device, according to new clinical data presented recently at the Society for Vascular Surgery`s “Vascular Annual Meeting.”
The five-year results from the study were presented by Dr. Michael J. Singh, associate professor of surgery at University of Pittsburgh Medical Center, during a late-breaking clinical trial session. The prospective, multi-center, non-randomized bifurcated arm of the study enrolled 150 patients at 26 U.S. medical centers, met its primary safety and effectiveness endpoints and contributed to the device`s approval by the U.S. Food and Drug Administration in December 2010. The study`s primary safety and effectiveness endpoints were major adverse events (MAE) at 30 days and successful aneurysm treatment at 12 months, respectively. Five year follow-up was also conducted. Significantly for clinical practice, the study comprised of patients with “landing zones,” or healthy aortic neck lengths, as short as 10 mm, whereas most other trials of aortic stent grafts have required neck lengths of at least 15 mm.
Highlights of the findings comprise 99.2 percent freedom from aneurysm related mortality and 89.0 percent freedom from secondary endovascular interventions through five years. In addition, an independent imaging core laboratory stated 95.2 percent of the patients` aneurysm sacs remained stable or reduced in diameter by more than 5 mm at five years. Indicative of excellent exclusion of the aneurysm, there were no (0.0%) Type I or III endoleaks at five years and no migrations occurred through the five-year follow-up.
Medtronic plc, a healthcare solutions company, provides medical technologies, services, and solutions worldwide. It operates through three segments: Cardiac and Vascular Group, Restorative Therapies Group, and Diabetes Group.
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