NDA Resubmission, Clinical Data and Findings, and Conference Participations - Analyst Notes on InterMune, ResMed, Seattle Genetics, Insulet and Charles River
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NEW YORK, June 5, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding InterMune Inc. (NASDAQ: ITMN), ResMed Inc. (NYSE: RMD), Seattle Genetics Inc. (NASDAQ: SGEN), Insulet Corporation (NASDAQ: PODD) and Charles River Laboratories International, Inc. (NYSE: CRL). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/3390-100free.
InterMune Inc. Analyst Notes
On May 27, 2014, InterMune Inc. (InterMune) announced that in response to a Complete Response Letter from the U.S Food and Drug Administration, requiring it to conduct phase 3 clinical trial on the efficacy of Pirfenidone for the treatment of adult patients with idiopathic pulmonary fibrosis (IPF), it has resubmitted its New Drug Application. The Company's President, Chairman and CEO, Dan Welch, commented on the resubmission saying, "We are pleased to have resubmitted the pirfenidone NDA and look forward to our interactions with the FDA. The final steps in preparing the resubmission were completed very smoothly and efficiently, allowing us to complete the process somewhat earlier than expected. If the FDA grants approval of our NDA within the six-month review period of an NDA resubmission, we would be ready to launch pirfenidone in the first quarter of 2015." The full analyst notes on InterMune are available to download free of charge at:
http://www.analystsreview.com/Jun-05-2014/ITMN/report.pdf
ResMed Inc. Analyst Notes
On May 21, 2014, ResMed Inc. (ResMed) presented the findings of the study it funded on the approach toward auto-adjusting positive airway pressure (APAP) therapy for sleep apnea sufferers. The study findings, which were presented at the American Thoracic Society 2014 International Conference, indicate that a new algorithm developed for women with sleep apnea can improve flow limitation and enable lower pressures for therapy, leading to a more comfortable therapy experience. "As we learn more about the condition and seek to improve ways to treat it, gender-specific approaches are an obvious next step, and are in line with ResMed's history of innovative, patient-centric solutions. We'll continue to support research in this area and seek to translate the knowledge gained into effective therapies," ResMed Vice President of Medical Affairs Jeff Armistead, Ph.D., commented on the results of the study. The full analyst notes on ResMed are available to download free of charge at:
http://www.analystsreview.com/Jun-05-2014/RMD/report.pdf
Seattle Genetics Inc. Analyst Notes
On June 1, 2014, Seattle Genetics Inc. (Seattle Genetics) presented data from interim phase 1 clinical trial of Antibody-Drug Conjugate (ADC) SGN-CD19A, at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting. The primary endpoints of the clinical trial are to estimate the maximum tolerated dose, to evaluate the safety of SGN-CD19A as well as antitumor activity, pharmacokinetics, progression-free survival and overall survival. Among the key findings of the clinical trial, the Company noted that no dose limiting toxicity was observed in the first cycle for any patients, and six out of 37 patients treated across all dose levels achieved a complete remission. The Company's Chief Medical Officer and Executive Vice President for Research and Development Jonathan Drachman, M.D., commented, "We continue to make strong progress advancing our proprietary pipeline programs, with SGN-CD19A representing one of five ADCs in clinical development. SGN-CD19A targets a promising cancer marker expressed in a variety of hematologic malignancies." The full analyst notes on Seattle Genetics are available to download free of charge at:
http://www.analystsreview.com/Jun-05-2014/SGEN/report.pdf
Insulet Corporation Analyst Notes
On May 29, 2014, Insulet Corporation (Insulet) announced that the Company's management team will present in the upcoming William Blair 34th Annual Growth Stock Conference at 3:30 p.m. CT on June 10-12, 2014 at the Four Seasons Chicago. A live webcast of the event can be accessed via the Company's website. The full analyst notes on Insulet are available to download free of charge at:
http://www.analystsreview.com/Jun-05-2014/PODD/report.pdf
Charles River Laboratories International, Inc. Analyst Notes
On June 2, 2014, Charles River Laboratories International, Inc. (Charles River) announced that it will be participating at the William Blair 34th Annual Growth Stock Conference in Chicago, Illinois on Wednesday, June 11, 2014, at 10:40 a.m. CDT (11:40 a.m. EDT). Management will present an overview of Charles River's strategic focus and business developments. The presentation will be webcast live via the Company's website. The full analyst notes on Charles River are available to download free of charge at:
http://www.analystsreview.com/Jun-05-2014/CRL/report.pdf
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