Priority Reviews, Preliminary Earnings Releases, Clinical Trials Results, and Launch of Website - Analyst Notes on Gilead, Pfizer, Intuitive Surgical, Alkermes and Quest
Editor Note: For more information about this release, please scroll to bottom.
NEW YORK, April 11, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Gilead Sciences Inc. (NASDAQ: GILD), Pfizer Inc. (NYSE: PFE), Intuitive Surgical, Inc. (NASDAQ: ISRG), Alkermes plc (NASDAQ: ALKS) and Quest Diagnostics Inc. (NYSE: DGX). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/989-100free.
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Gilead Sciences Inc. Analyst Notes
On April 7, 2014, Gilead Sciences Inc. (Gilead) announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company's New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. The Company had filed the NDA for LDV/SOF on February 10, 2014, and now the FDA has decided a target action date under the Prescription Drug User Fee Act of October 10, 2014. According to Gilead, the FDA has also assigned LDV/SOF a Breakthrough Therapy designation. FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The full analyst notes on Gilead are available to download free of charge at:
http://www.analystsreview.com/989-GILD-11Apr2014.pdf
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Pfizer Inc. Analyst Notes
On April 6, 2014, Pfizer Inc. (Pfizer) announced detailed results of the PALOMA-1 study, a randomized Phase II study of palbociclib in combination with letrozole. According to the Company, PALOMA-1 achieved its primary endpoint by significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. It was observed that women treated with the combination of palbociclib plus letrozole reported median PFS of 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who were treated with letrozole alone. As stated by Pfizer, final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate demonstrated superiority in the palbociclib plus letrozole arm compared to the letrozole-only arm. The full analyst notes on Pfizer are available to download free of charge at:
http://www.analystsreview.com/989-PFE-11Apr2014.pdf
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Intuitive Surgical, Inc. Analyst Notes
On April 8, 2014, Intuitive Surgical, Inc. (Intuitive Surgical) announced its preliminary results for Q1 2014 ahead of the April 22, 2014 release of its Q1 2014 financial results. The Company expects revenue for Q1 2014 to be approximately $465 million, down 24% compared with $611 million for Q1 2013. The revenue estimates includes a $26 million deferral associated with a customer trade-out program for the newly launched da Vinci XiTM Surgical System. Excluding the impact of the trade-out program, revenue would have been $491 million, a decrease of 20% YoY. The Company also announced a pre-tax charge of $67 million to reflect estimated costs of settling a number of product liability legal claims against the Company. Shares of Intuitive Surgical sank 6.78%, a day after, and closed at $456.64. The stock is down 15.63% from its 52-week high of $541.23, which it made on April 3, 2014. The full analyst notes on Intuitive Surgical are available to download free of charge at:
http://www.analystsreview.com/989-ISRG-11Apr2014.pdf
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Alkermes plc Analyst Notes
On April 8, 2014, Alkermes plc (Alkermes) announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. According to the Company, patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil confirmed statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo. The full analyst notes on Alkermes are available to download free of charge at:
http://www.analystsreview.com/989-ALKS-11Apr2014.pdf
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Quest Diagnostics Inc. Analyst Notes
On April 7, 2014, Quest Diagnostics Inc. (Quest Diagnostics) announced that patients nationwide can directly access their personal laboratory test results through the Company's secure patient portal, MyQuest® by Care360. The Company informed that it provides diagnostic information services to about 30% of American adults each year. Under a federal rule issued on the aforesaid date, patients in all 50 states and the District of Columbia can now access test results from diagnostic information service providers without first being authorized by a physician. Further, the Company's patient portal is also designed to help physicians that use the Quest Diagnostics Care360 Electronic Health Record (EHR) to qualify for the Centers for Medicare and Medicaid (CMS) EHR Incentive Program. The full analyst notes on Quest are available to download free of charge at:
http://www.analystsreview.com/989-DGX-11Apr2014.pdf
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EDITOR'S NOTES:
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1. This is not company news. We are an independent source and our views do not reflect the companies mentioned.
2. This release was reviewed by Ananya Ghosh, a CFA charter-holder. If you notice any errors or omissions, please notify us below.
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