Clinical Trial Updates, Leadership Appointments, and Earnings Results - Analyst Notes on Tesaro, Novavax, Vanda, Insmed and Durata
Editor Note: For more information about this release, please scroll to bottom.
NEW YORK, May 15, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Tesaro, Inc. (NASDAQ: TSRO), Novavax, Inc. (NASDAQ: NVAX), Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA), Insmed Incorporated (NASDAQ: INSM) and Durata Therapeutics, Inc. (NASDAQ: DRTX). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/2470-100free.
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Tesaro, Inc. Analyst Notes
On May 12, 2014, Tesaro, Inc. (Tesaro) announced positive top-line results from the third and final Phase 3 trial of rolapitant - an investigational neurokinin-1 receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The study successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. "In our view, these results describe a differentiated profile for rolapitant. We are enthusiastic about the potential for this product candidate, with a profile that may include an extended half life; convenient, single-dose oral and intravenous formulations; and a lack of CYP3A4-mediated drug interactions," said Mary Lynne Hedley, Ph.D., President of TESARO. "We are very pleased with these data, and we look forward to presenting the detailed results of this trial, together with the results of our prior to Phase 3 trials, at the upcoming American Society of Clinical Oncology (ASCO) annual meeting." The full analyst notes on Tesaro are available to download free of charge at:
http://www.analystsreview.com/2470-TSRO-15May2014.pdf
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Novavax, Inc. Analyst Notes
On May 6, 2014, Novavax, Inc. (Novavax) announced that Sven Andréasson has been appointed as the Company's Senior Vice President of Corporate Development, effective June 2, 2014. His responsibilities will include the identification, prioritization, and evaluation of new strategic opportunities that leverage the Company's core strengths and growth initiatives. Mr. Andréasson joins Novavax with an extensive experience in biopharmaceutical operations, executive management, and strategic development gained after many years in the industry. The full analyst notes on Novavax are available to download free of charge at:
http://www.analystsreview.com/2470-NVAX-15May2014.pdf
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Vanda Pharmaceuticals, Inc. Analyst Notes
On May 8, 2014, Vanda Pharmaceuticals, Inc. (Vanda) reported its Q1 2014 financial results with total revenues of $9.1 million compared to $8.1 million in Q1 2013. Q1 2014 net loss was $26.5 million or $0.79 per diluted share, compared to $4.5 million or $0.16 per diluted share in Q1 2013. For full year 2014, the Company anticipates operating expenses to be in the range of $110.0 million to $120.0 million. As of March 31, 2014, the Company reported cash, cash equivalents, and marketable securities of $100.4 million. The full analyst notes on Vanda are available to download free of charge at:
http://www.analystsreview.com/2470-VNDA-15May2014.pdf
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Insmed Incorporated Analyst Notes
On May 8, 2014, Insmed Inc. (Insmed) reported its Q1 2014 financial results with net loss of $14.3 million, or $0.36 loss per share, compared to a net loss of $13.7 million, or $0.43 loss per share, in Q1 2013. Research and development expenses increased to $11.4 million compared to $10.3 million in Q1 2013, primarily attributable to the increase in internal expenses and manufacturing expenses incurred during the completion of certain process improvement projects and the manufacture of ARIKAYCE for clinical supply. "We remain on track to discuss our recent clinical results with the U.S. Food and Drug Administration and the European Medicines Agency to determine next steps for ARIKAYCE," said Will Lewis, President and CEO of Insmed. "We look forward to the presentations of ARIKAYCE data at the American Thoracic Society's Annual Meeting later this month. The presentation of the NTM data will include data from the three month, open label portion of the study." The full analyst notes on Insmed are available to download free of charge at:
http://www.analystsreview.com/2470-INSM-15May2014.pdf
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Durata Therapeutics, Inc. Analyst Notes
On May 8, 2014, Durata Therapeutics, Inc. (Durata) reported its Q1 2014 financial results with GAAP net loss of $20.0 million compared to a net loss of $15.8 million in Q1 2013. Net loss per common share was $0.75 and $0.86, respectively. Research and development expenses were $9.0 million compared to $11.1 million in Q1 2013, and the decrease was primarily due to a $2.4 million decrease related to clinical trial activities following the completion of the DISCOVER trials. "The first quarter of 2014 ended on a high note with the unanimous recommendation by the FDA's Anti-Infective Drugs Advisory Committee for the approval of Dalvance," said Paul R. Edick, CEO of Durata. "We are very focused on several major milestones, which include preparing for the May 26th action date for the FDA's review of our NDA and an anticipated launch of Dalvance in the third quarter of 2014, as well as advancing additional studies of dalbavancin, among other initiatives." The full analyst notes on Durata are available to download free of charge at:
http://www.analystsreview.com/2470-DRTX-15May2014.pdf
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