Positive Clinical Trial Results, Regulatory Wins, and New Appointments - Research Report on Incyte, Edwards, ACADIA Pharmaceuticals, Alnylam, and Ironwood
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NEW YORK, August 26, 2013 /PRNewswire/ --
Today, Investors' Reports announced new research reports highlighting Incyte Corporation (NASDAQ: INCY), Edwards Lifesciences Corp. (NYSE: EW), ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY), and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Incyte Corporation Research Report
On August 21, 2013, Incyte Corporation (Incyte) announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, the Company's oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. The Company stated that the hazard ratio (HR) for overall survival (OS) in the intent to treat population was 0.79 (one-sided p=0.12), and in a pre-specified subgroup analysis conducted in patients identified prospectively as most likely to benefit from JAK pathway inhibition, the HR for OS was 0.47 (one-sided p=0.005). In addition, Incyte reported that within the pre-specified subgroup of patients, which represented 50% of the randomized population, 6 month survival in the ruxolitinib arm was 42% vs. 11% for placebo. Paul A. Friedman, M.D., Incyte's President and CEO said, "Coupled with the overall survival benefit observed in the ongoing Phase III trials in myelofibrosis, these results solidify our belief in the therapeutic opportunity that exists for Jakafi, and provide us with an acceleration strategy to advance our JAK1 inhibitor portfolio into additional areas of unmet medical need." The Full Research Report on Incyte Corporation - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-08-21/INCY]
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Edwards Lifesciences Corp. Research Report
On August 21, 2013, Edwards Lifesciences Corp. (Edwards) announced that Japan's Central Social Insurance Medical Council (Chuikyo) has given consent to the recommendation by the Japanese Ministry of Health, Labor, and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards SAPIEN XT transcatheter aortic heart valve. According to the Company, with this approval Chuikyo established a reimbursement of 4.5 million yen (c.$46,000) for when the SAPIEN XT valve is used in the treatment of patients with severe symptomatic aortic stenosis. The Company informed that the reimbursement is scheduled to go into effect on October 1, 2013. The Full Research Report on Edwards Lifesciences Corp. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-08-21/EW]
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ACADIA Pharmaceuticals Inc. Research Report
On August 19, 2013, ACADIA Pharmaceuticals Inc. (ACADIA) announced the appointment of Terrence Moore as the Company's Executive Vice President and Chief Commercial Officer, with immediate effective. According to the Company, prior to joining ACADIA, Mr. Moore served as a principal of Cook-Moore Consulting and also served as Vice President at Transcept Pharmaceuticals where he was responsible for commercial strategy, business development, and commercial alliance activities. The Company also stated that in his new role, Mr. Moore will be responsible to lead ACADIA's commercial activities. Uli Hacksell, Ph.D, CEO of ACADIA Pharmaceuticals, said, "Terry's marketing expertise and demonstrated ability to execute will help position ACADIA for success in the planned launch of pimavanserin in Parkinson's disease psychosis and for effective life cycle management in order to maximize pimavanserin's commercial potential." The Full Research Report on ACADIA Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-08-21/ACAD]
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Alnylam Pharmaceuticals Inc. Research Report
On August 20, 2013, Alnylam Pharmaceuticals, Inc. (Alnylam) announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to ALN-AT3 as a therapeutic for the treatment of hemophilia A. Earlier, on August 14, 2013, the Company announced that the FDA granted ODD to ALN-AT3 for the treatment of hemophilia B. Saraswathy Nochur, Ph.D., Senior Vice President, Regulatory Affairs and Quality Assurance at Alnylam, said, "We are very pleased that the FDA has granted Orphan Drug Designation for ALN-AT3 now for both the treatment of hemophilia A and hemophilia B. As a subcutaneously delivered RNAi therapeutic, we believe it represents an innovative approach for the management of hemophilia and has great potential to make a meaningful impact in the treatment of this often debilitating bleeding disorder." The Company also intends to file an investigational new drug (IND) application for ALN-AT3 in Q4 2013 and initiate a Phase I clinical trial in early 2014. The Full Research Report on Alnylam Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-08-21/ALNY]
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Ironwood Pharmaceuticals, Inc. Research Report
On August 21, 2013, Ironwood Pharmaceuticals, Inc. (Ironwood) announced the appointment of Michael Hall, MB. BCH as the Company's Senior Vice President of Clinical Development. According to Ironwood, Dr. Hall will lead its clinical research, clinical development, clinical operations, biostatistics, and pharmacovigilance teams. In addition, Ironwood stated that Mr. Hall will oversee clinical trials investigating additional appropriate populations for linaclotide, as well as the Company's pipeline of early development candidates. Prior to joining Ironwood, Dr. Hall served as chief medical officer and senior vice president at Repligen Corp. Mark Currie, Ph.d., Senior Vice President, Chief Scientific Officer, and President of Research and Development at Ironwood, said, "Michael's unique combination of drug development experience, deep scientific knowledge, patient-oriented medical perspective, and proven leadership capabilities will be of significant value in supporting our clinical development activities." The Full Research Report on Ironwood Pharmaceuticals, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-08-21/IRWD]
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