Regulatory Updates, Clinical Trial Results, and Stock Price Movements - Research Report on Johnson & Johnson, Cubist, Regeneron, Medtronic, and Jazz Pharmaceuticals
NEW YORK, December 19, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Analysts' Corner announced new research reports highlighting John & Johnson (NYSE: JNJ), Cubist Pharmaceuticals Inc. (NASDAQ: CBST), Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), Medtronic, Inc. (NYSE: MDT), and Jazz Pharmaceuticals plc (NASDAQ: JAZZ). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Johnson & Johnson Research Report
On December 12, 2013, Janssen Research & Development, LLC (Janssen Research), part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Johnson & Johnson), announced that it has received a complete response letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes. According to the Company, the complete response letter requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin (as part of the canagliflozin and metformin FDC) and the once-daily dosing of canagliflozin as a single agent. Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development leader at Janssen Research, said, "We continue to have productive discussions with the FDA and will work closely with the agency to advance this application. We look forward to addressing questions from the FDA as soon as possible and remain committed to providing therapeutic options that meet the needs of the type 2 diabetes community." Janssen Research further reported that it believes it can supply this information based on available clinical data from the comprehensive Phase 3 clinical development program for canagliflozin. The Full Research Report on John & Johnson - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:
http://www.analystscorner.com/r/full_research_report/07a8_JNJ
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Cubist Pharmaceuticals Inc. Research Report
On December 16, 2013, Cubist Pharmaceuticals Inc. (Cubist) announced positive top-line results from the Company's pivotal Phase 3 clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI). According to the Company, ceftolozane/tazobactam, in combination with metronidazole, met the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) defined primary endpoints of statistical non-inferiority compared to meropenem. Cubist reported that the primary endpoint was a clinical cure rate of 26 - 30 days after the initiation of therapy. According to Cubist, for the FDA, the primary analysis was conducted in the Microbiological Intent-to-Treat (MITT) population, where the non-inferiority margin was 10% and the lower and upper bounds of the 95% confidence interval were -8.9% and 0.5%, respectively. Cubist further reported that for the EMA, the primary analysis population was Clinically Evaluable (CE) patients, where the non-inferiority margin was 12.5% and the lower and upper bounds of the 99% confidence interval were -4.2% and 4.3%, respectively. The Full Research Report on Cubist Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:
http://www.analystscorner.com/r/full_research_report/92f2_CBST
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Regeneron Pharmaceuticals Inc. Research Report
On December 16, 2013, Regeneron Pharmaceuticals Inc.'s (Regeneron) stock declined 0.42%, ending the day at $268.45. Over the previous three trading sessions, shares of Regeneron declined 0.58% compared to the Nasdaq Composite which gained 0.64% during the same period. The Full Research Report on Regeneron Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:
http://www.analystscorner.com/r/full_research_report/8ea7_REGN
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Medtronic, Inc. Research Report
On December 9, 2013, Medtronic, Inc. (Medtronic) announced the first-in-human implant of Micra Transcatheter Pacing System (TPS). The Company reported that the device, which is an investigational device worldwide, was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial. Reporting the device as the world's smallest pacemaker, Medtronic informed that at one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Medtronic added that after it is positioned, the pacemaker is securely attached to the heart wall and can be repositioned if needed. Clemens Steinwender, M.D., Head of Cardiology at the Linz General Hospital in Linz, Austria, said, "Because of its small size and unique design, the Micra TPS can be introduced directly into the heart via a minimally invasive procedure, without the need for leads. The combination of this novel technology with a transcatheter procedure can benefit patients by potentially reducing pocket or lead complications and recovery times observed with traditional surgical pacemaker implants." The Full Research Report on Medtronic, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:
http://www.analystscorner.com/r/full_research_report/bc94_MDT
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Jazz Pharmaceuticals plc Research Report
On December 16, 2013, Jazz Pharmaceuticals plc's (Jazz Pharmaceuticals) stock declined 2.04%, ending the day at $112.19. Over the previous three trading sessions, shares of Jazz Pharmaceuticals declined 2.63% compared to the Nasdaq Composite which gained 0.64% during the same period. The Full Research Report on Jazz Pharmaceuticals plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:
http://www.analystscorner.com/r/full_research_report/5fe3_JAZZ
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