SmallCapReview: Small Cap Stocks To Watch - AEGR, GIVN, NVAX
Oct 18, 2012 (Menafn - M2 PRESSWIRE via COMTEX) --Aegerion Pharmaceuticals AEGR 19.15. Announced Wednesday after market close that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) determined by a vote of 13 to 2 that Aegerion has presented sufficient safety and efficacy data to support marketing of its product, lomitapide, for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH) when used as an adjunct to a low-fat diet and other lipid-lowering therapies.
"Today's Advisory Committee recommendation is an important milestone in our mission to provide patients with HoFH with urgently needed new treatment options to lower their cholesterol levels," said Marc Beer, Chief Executive Officer of Aegerion Pharmaceuticals. "We look forward to continuing to work closely with the FDA as the agency completes its review of our new drug application for lomitapide."
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 29, 2012, for completion of its review of the New Drug Application (NDA) for lomitapide. The EMDAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the EMDAC's recommendation, but will consider the committee's recommendation as the FDA completes its review of the lomitapide NDA.
What They Do: Aegerion Pharmaceuticals, Inc.is an emerging biopharmaceutical company focused on the development and commercialization of novel, life-altering therapeutics to treat debilitating and often fatal rare diseases.
Given Imaging GIVN 15.27. Announced Wednesday after market close that in order to maximize growth and enhance shareholder value the Company is currently evaluating a range of strategic options, including preliminary non-binding indications of interest received from a number of parties relating to a possible merger or sale of the Company.
The Company intends to continue to actively explore these and other alternatives, including a strategic alliance or additional acquisitions such as the recently announced acquisition of the assets of The Smart Pill Corporation.The Board of Directors has appointed an executive committee consisting of the Chairman and two independent directors to oversee the process. The investment banking firm Barclays is assisting the Company in this process.
What They Do: Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system.
Novavax NVAX 2.24. Announced Wednesday after market close positive top-line results from two Phase 1 clinical trials of its A/H5N1 avian influenza vaccine candidate administered alone or with either one of two undisclosed adjuvants.
The trials' primary objectives of demonstrating the safety and immunogenicity of varying dose-levels of the vaccine, with and without adjuvant, and the demonstration of statistically significant adjuvant effects on the immune responses were achieved. The vaccine safety was acceptable with no vaccine-related serious adverse events observed.
Stanley C. Erck, President and CEO of Novavax, stated, "The data from these trials represent a landmark event in the history of Novavax. We have demonstrated that Novavax can produce antigens from avian influenza strains that are as, or more, immunogenic than any other described in published results to date. Importantly, as we accelerate our development activities, these results give us tremendous flexibility for pursuing pandemic vaccine products, including vaccines directed at population segments that are sensitive to adjuvant use."
The two randomized, observer-blind, dose-ranging, placebo-controlled Phase 1 trials were conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). The primary objectives of the two trials were to demonstrate the safety and immunogenicity of Novavax' VLP-based H5N1 vaccine candidate at varying dose-levels, with and without an adjuvant, using identical clinical study designs but with a different adjuvant in each study. A total of 666 healthy adults 18 to 49 years old were enrolled in the two trials. Each subject received intramuscular injections of vaccine or placebo at day 0 and day 21, and will be followed for 13 months following the first dose. The current data relate to safety and immune responses over the first 42 days.
What They Do: Novavax is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide.
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