Complete Response Letter from FDA, Positive Opinion on Drug, Technical Update, Financial Result Release, and Clinical Trial Results - Research Reports on AcelRx, Horizon, Gilead, AbbVie and Exelixis
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NEW YORK, July 31, 2014 /PRNewswire/ --
Today, Analysts Review released its research reports regarding AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX), Horizon Pharma Inc. (NASDAQ: HZNP), Gilead Sciences Inc. (NASDAQ: GILD), AbbVie Inc. (NYSE: ABBV) and Exelixis Inc. (NASDAQ: EXEL). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/5305-100free.
AcelRx Pharmaceuticals Inc. Research Reports
On July 25, 2014, AcelRx Pharmaceuticals Inc. (AcelRx) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in relation to the Company's new drug application (NDA) for Zalviso™ (sufentanil sublingual tablet system). AcelRx informed that the CRL contains requests for additional information on the Zalviso System to ensure proper use of the device, in addition to other requests, including provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. AcelRx added that after reviewing the FDA's comments and requests in the CRL, it will discuss the same with the FDA. Richard King, President and CEO of AcelRx, said, "We believe we can satisfy all of FDA's requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA." The full research reports on AcelRx are available to download free of charge at:
http://www.analystsreview.com/Jul-31-2014/ACRX/report.pdf
Horizon Pharma Inc. Research Reports
On July 28, 2014, Horizon Pharma Inc.'s (Horizon) stock plummeted 34.17% to end the trading session at $9.15 after Chicago Tribune reported that CVS Caremark or Express Scripts are planning to announce next month that DUEXIS® and VIMOVO® would be removed from their formularies and will be placed on their exclusion lists effective January 1, 2015. Share in Horizon opened the session at $10.05 and oscillated in the range of $10.21 - $9.04. A total of 15.35 million shares were traded during the day, which is above its 30-day average volume of 1.34 million shares. The full research reports on Horizon are available to download free of charge at:
http://www.analystsreview.com/Jul-31-2014/HZNP/report.pdf
Gilead Sciences Inc. Research Reports
On July 25, 2014, Gilead Sciences Inc. (Gilead) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has provided a positive opinion on the Company's Marketing Authorization Application (MAA) for Zydelig® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL). Gilead informed that CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The full research reports on Gilead are available to download free of charge at:
http://www.analystsreview.com/Jul-31-2014/GILD/report.pdf
AbbVie Inc. Research Reports
On July 25, 2014, AbbVie Inc. (AbbVie) released its Q2 2014 and H1 2014 financial results. The Company reported Q2 2014 net sales of $4.9 billion, up 5.0% YoY. The Company's Q2 2014 net earnings came in at $1.1 billion or $0.68 per diluted share, compared to net earnings of $1.1 billion or $0.66 per diluted share in Q2 2013. The Company's H1 2014 net sales improved 5.2% YoY to $9.5 billion. The Company's H1 2014 net earnings came in at $2.1 billion or $1.29 per diluted share, compared to net earnings of $2.0 billion or $1.27 per diluted share in H1 2013. For Q3 2014, the Company expects GAAP diluted EPS in the range of $0.68 - $0.70, while for full-year 2014, the Company expects diluted EPS in the range of $2.69 to $2.79. The full research reports on AbbVie are available to download free of charge at:
http://www.analystsreview.com/Jul-31-2014/ABBV/report.pdf
Exelixis Inc. Research Reports
On July 14, 2014, Exelixis Inc. (Exelixis) announced positive top-line results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by the Company, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation. Exelixis' collaborator Genentech, a member of the Roche Group, informed the Company that coBRIM met its primary endpoint, delivering a statistically significant increase in progression-free survival (PFS) for the combination of cobimetinib plus vemurafenib as compared to vemurafenib alone. The Company stated that Genentech is planning to present the coBRIM data at an upcoming medical meeting and plans to initiate regulatory filings before year end. The full research reports on Exelixis are available to download free of charge at:
http://www.analystsreview.com/Jul-31-2014/EXEL/report.pdf
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