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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

Editor Note: For more information about this release, please scroll to bottom.


News provided by

Analysts Review

Jul 31, 2014, 09:20 ET

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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

About Analysts Review
We do things differently. Our goal is to provide the best content to our exclusive membership. We are constantly hiring researchers, writers, editors and analysts to add to our team and become better than yesterday. If being a part of a fast growing community with an edge in today's market sounds interesting to you, then sign-up today and experience the full benefits of membership.

EDITOR'S NOTES:

1. This is not company news. We are an independent source and our views do not reflect the companies mentioned.

2. Information in this release is produced on a best efforts basis by Rohit Tuli, a CFA charterholder. The content is then further fact checked and reviewed by an outsourced research provider. However, we are only human and are prone to make mistakes. If you notice any errors or omissions, please notify us below.

3. This information is submitted as a net-positive to companies mentioned, to increase awareness for mentioned companies to our subscriber base and the investing public.

4. If you wish to have your company covered in more detail by our team, or wish to learn more about our services, please contact us at pubco [at] http://www.analystsreview.com.

5. For any urgent concerns or inquiries, please contact us at compliance [at] http://www.analystsreview.com.

6. Are you a public company? Would you like to see similar coverage on your company? Send us a full investors' package to research [at] http://www.analystsreview.com for consideration.

COMPLIANCE PROCEDURE
Content is researched, written and reviewed on a best-effort basis. This document, article or report is prepared and authored by Analysts Review, represented by Rohit Tuli, CFA. An outsourced research services provider has only reviewed the information provided by Analysts Review in this article or report according to the procedures outlined by Analysts Review. Analysts Review is not entitled to veto or interfere in the application of such procedures by the outsourced provider to the articles, documents or reports, as the case may be.

NOT FINANCIAL ADVICE
Analysts Review makes no warranty, expressed or implied, as to the accuracy or completeness or fitness for a purpose (investment or otherwise), of the information provided in this document. This information is not to be construed as personal financial advice. Readers are encouraged to consult their personal financial advisor before making any decisions to buy, sell or hold any securities mentioned herein.

NO WARRANTY OR LIABILITY ASSUMED
Analysts Review is not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted by Analysts Review whatsoever for any direct, indirect or consequential loss arising from the use of this document. Analysts Review expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Analysts Review does not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

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