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Product Development Strategies, FDA Approval, Incremental Agreement, New Clinical Studies, and Other Announcements - Research Report on Amarin, Discovery Labs, Auxilium, Novavax, and Accuray


News provided by

Analysts' Corner

Oct 09, 2013, 08:00 ET

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NEW YORK, October 9, 2013 /PRNewswire/ --

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

Today, Analysts' Corner announced new research reports highlighting Amarin Corporation plc (NASDAQ: AMRN), Discovery Laboratories Inc. (NASDAQ: DSCO), Auxilium Pharmaceuticals Inc. (NASDAQ: AUXL), Novavax, Inc. (NASDAQ: NVAX), and Accuray Incorporated (NASDAQ: ARAY). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.

Amarin Corporation plc Research Report

On October 3, 2013, Amarin Corporation plc (Amarin) announced that the Company received a notification from the U.S. Food and Drug Administration's (FDA) in connection to a scheduled advisory committee meeting. According to the Company, FDA has notified that the meeting which is scheduled to be held on October 16, 2013 in relation with the proposed Vascepa® (icosapent ethyl) ANCHOR indication will take place as scheduled despite the current Federal Government lapse in appropriations. The Full Research Report on Amarin Corporation plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/7cf9_AMRN]

--

Discovery Laboratories Inc. Research Report

On October 4, 2013, Discovery Laboratories Inc. (Discovery Labs) announced that the Company has received approval from the US Food and Drug Administration (FDA) for its updated product specifications for SURFAXIN (lucinactant) Intratracheal Suspension. According to the Company, SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of respiratory distress syndrome (RDS) in premature infants, and the only approved alternative to animal-derived surfactants currently used today. John G. Cooper, CEO of Discovery Labs commented, "SURFAXIN represents the first milestone in our goal of transforming the treatment of RDS and is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants for the prevention of RDS." The Company informed that it has started manufacturing of SURFAXIN for its planned commercial introduction in Q4 2013. The Full Research Report on Discovery Laboratories Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/2f42_DSCO]

--

Auxilium Pharmaceuticals Inc. Research Report

On September 20, 2013, Auxilium Pharmaceuticals, Inc. (Auxilium) announced an Incremental Assumption Agreement with Morgan Stanley Senior Funding, Inc. (MSSF), under Auxilium's existing Credit Agreement with the latter. The Company stated that under the Incremental Agreement, Auxilium has raised an additional $50 million from a syndicate of lenders, on terms which are consistent with its existing $225 million senior secured credit facility. The Company informed that it intends to use these proceeds for general corporate purposes, including potential corporate development and licensing activities. The Full Research Report on Auxilium Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/86a4_AUXL]

--

Novavax, Inc. Research Report

On September 24, 2013, Novavax, Inc. (Novavax) announced that after the successful completion of process improvement studies, the Company is finalizing details on costs and timelines for their next round of clinical studies with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA). According to the Company, Novavax has initiated these trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. According to the Company, the pandemic study will include the use of Novavax' proprietary saponin-based adjuvant Matrix-M™.  Stanley C. Erck, President and CEO said, "Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal. Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9." The Full Research Report on Novavax, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/bc35_NVAX]

--

Accuray Incorporated Research Report

On October 3, 2013, Accuray Incorporated (Accuray) announced the that studies presented at the 55th Annual American Society for Radiation Oncology (ASTRO) Meeting in Atlanta affirms evidence of clinical and quality of life benefits for the CyberKnife and TomoTherapy Systems. Accuray informed that at the meeting, several indications including prostate, lung, liver, breast and head and neck cancers were represented among the 104 oral and poster presentations, further strengthening Accuray's position as a leader in precise, innovative radiation oncology therapies. Joshua H. Levine, President and CEO of Accuray said, "Data on the CyberKnife System continued to support that it is the best option for SBRT, while data on the TomoTherapy System reinforced its ability to treat the entire spectrum of radiation oncology patients. Perhaps most importantly for us, the feedback shared by our clinical partners using the new CyberKnife M6 and TomoTherapy H Series sparked several discussions among their colleagues about how both technologies can help expand patient access to the most precise, leading-edge radiation therapies available. We look forward to working with our customers to continue to learn from and share their experiences with the radiation oncology community." The Full Research Report on Accuray Incorporated - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/36bf_ARAY]

----

EDITOR 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 fact checked and produced on a best efforts basis and reviewed by Namrata Maheshwari, a CFA charterholder. 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 [email protected].
  5. For any urgent concerns or inquiries, please contact us at [email protected].
  6. Are you a public company? Would you like to see similar coverage on your company? Send us a full investors' package to [email protected] 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 Equity News Network. An outsourced research services provider represented by Namrata Maheshwari, CFA, has only reviewed the information provided by Equity News Network in this article or report according to the Procedures outlined by Equity News Network. Equity News Network 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

Equity News Network 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

Equity News Network 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 Equity News Network whatsoever for any direct, indirect or consequential loss arising from the use of this document. Equity News Network expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Equity News Network 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.

http://AnalystsCorner.com

 

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