Positive Data, Financial Results, and Drug Development Programs - Analyst Notes on Novavax, Ironwood, XOMA, Luminex and Amicus - WTOC-TV: Savannah, Beaufort, SC, News, Weather & Sports

Positive Data, Financial Results, and Drug Development Programs - Analyst Notes on Novavax, Ironwood, XOMA, Luminex and Amicus

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NEW YORK, May 2, 2014 /PRNewswire/ --

Today, Analysts Review released its analysts' notes regarding Novavax, Inc. (NASDAQ: NVAX), Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD), XOMA Corporation (NASDAQ: XOMA), Luminex Corporation (NASDAQ: LMNX) and Amicus Therapeutics, Inc. (NASDAQ: FOLD). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/1940-100free.

Novavax, Inc. Analyst Notes
On April 28, 2014, Novavax, Inc. (Novavax) announced positive top-line data from its RSV-F protein nanoparticle vaccine candidate in a dose-confirmatory Phase 2 clinical trial in women of childbearing age. The study aims to evaluate the immunogenicity and safety of RSV-F protein. The results of the study showed that the RSV-F vaccine candidate was well-tolerated, with no vaccine-related serious adverse events, at all doses and formulations. The safety profile was consistent with data from prior Phase 1 and 2 studies. Commenting on the data, Gregory Glenn, M.D., Senior Vice President Research and Development at Novavax said, "Our vaccine has again performed in a highly consistent manner from a safety and immunogenicity perspective. In testing for an optimal formulation, we have delivered improved immunogenicity in a one-dose regimen. We believe such a regimen will improve patient convenience, vaccine uptake and compliance, thus decreasing the burden of RSV disease." The full analyst notes on Novavax are available to download free of charge at:


Ironwood Pharmaceuticals Inc. Analyst Notes
On April 29, 2014, Ironwood Pharmaceuticals, Inc. (Ironwood) announced its Q1 2014 financial results and recent business activities. The Company reported revenue of $14.6 million, compared to $3.3 million in Q1 2013. Net loss was approximately $49.6 million, or $0.38 per diluted share, compared to $93.9 million, or $0.87 per share, in Q1 2013. LINZESS net product sales were $60.8 million, compared to $4.5 million in Q1 2013. The Company anticipates full-year 2014 total operating expenses to be in the range of $215 million to $245 million and marketing and sales expenses for LINZESS to be in the range of $240 million to $270 million. The full analyst notes on Ironwood are available to download free of charge at:


XOMA Corporation Analyst Notes
On April 28, 2014, XOMA Corp. (XOMA) announced the finalization of its plans for a gevokizumab, an IL-1 beta modulating antibody, Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. The Company informed that in a meeting with the U.S. FDA, the data generated from XOMA's pilot trial in six PG patients was reviewed. The pilot study aims to determine if gevokizumab should be explored in pivotal studies in patients with active PG. The primary endpoint of the study is complete wound closure of the target ulcer at approximately four months. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The full analyst notes on XOMA are available to download free of charge at:


Luminex Corporation Analyst Notes
On April 28, 2014, Luminex Corp. (Luminex) reported its Q1 2014 financial results with revenues of $56.6 million, up 6.3% YoY. GAAP net income totaled $6.0 million, or $0.14 per diluted share, compared to a GAAP net loss of $2.5 million, or $0.06 per diluted share in Q1 2013. Patrick J. Balthrop, President and CEO of Luminex said, "We began 2014 with a quarter of solid financial performance, driven by strong growth in our assay business as highlighted above. We are optimistic about the continued prospects and future success of our assay segment, given our current portfolio and pipeline." The Company reaffirmed its 2014 annual revenue guidance between $225 million and $240 million. The full analyst notes on Luminex are available to download free of charge at:


Amicus Therapeutics, Inc. Analyst Notes
On April 29, 2014, Amicus Therapeutics, Inc. (Amicus) announced positive data from its Phase 3 study (Study 011) of migalastat monotherapy in Fabry patients with amenable mutations. Study 011 aims to measure the reduction of disease substrate following treatment with migalastat. The data showed that subjects who switched from placebo to migalastat after month 6 demonstrated a statistically significant reduction in kidney interstitial capillary GL-3 at month 12. The Company reported that the data shows that subjects who remained on migalastat for 12 months demonstrated a durable reduction in kidney interstitial capillary GL-3. John F. Crowley, Chairman and CEO of Amicus, stated, "Pending positive data from our second Phase 3 study we expect to meet with regulatory authorities to discuss these data and determine the fastest registration pathway for migalastat." The full analyst notes on Amicus are available to download free of charge at:


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