Drug Approvals, License Applications, Partnerships, and Positive Results Underline Growth for Biotech Companies - Research Report on Vertex, Theravance, Array BioPharma, Immunomedics, and Cytokinetics
NEW YORK, July 17, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Wall Street Reports announced new research reports highlighting Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), Theravance Inc. (NASDAQ: THRX), Array BioPharma, Inc. (NASDAQ: ARRY), Immunomedics Inc. (NASDAQ: IMMU), and Cytokinetics, Incorporated (NASDAQ: CYTK). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Vertex Pharmaceuticals Incorporated Research Report
On July 9, 2013, Vertex Pharmaceuticals Incorporated (Vertex) announced that it has received an approval for KALYDECO (ivacaftor) from the Therapeutic Goods Administration (TGA) of Australia. According to Vertex KALYDECO (ivacaftor) is used for the treatment of cystic fibrosis (CF) in patients of ages 6 and older, who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Simon Bedson, Senior Vice President of International Commercial Operations for Vertex, commented, "The approval of KALYDECO in Australia is an important milestone for the cystic fibrosis community." Bedson added, "The rapid review and approval by the TGA is a major step in making KALYDECO available for eligible Australians." The Full Research Report on Vertex Pharmaceuticals Incorporated - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.WSReports.com/r/full_research_report/ec92_VRTX]
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Theravance Inc. Research Report
On July 12, 2013, Theravance Inc. (Theravance) and GlaxoSmithKline (GSK) jointly announced that the license application for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name RELVAR ELLIPTA) in patients with chronic obstructive pulmonary disease (COPD) has been withdrawn from the current Japanese New Drug Application (JNDA). The Companies reported that the review of FF/VI for use in patients with asthma is continuing to progress through the normal Japanese regulatory process as part of this JNDA. Theravance and GSK also stated that they are currently determining next steps and possible clinical studies of FF/VI for the treatment of Japanese patients with COPD to support the resubmission. The Full Research Report on Theravance Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.WSReports.com/r/full_research_report/f77e_THRX ]
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Array BioPharma, Inc. Research Report
On July 10, 2013, Array BioPharma, Inc. (Array) and Loxo Oncology, Inc., a biopharmaceutical company recently established and funded by Aisling Capital, jointly announced that they have reached a multi-year license and collaboration agreement for an Array-invented preclinical development candidate and related intellectual property. Ron Squarer, CEO of Array, stated, "We are delighted to enter into this collaboration with the goal of rapidly bringing this exciting technology to cancer patients." Squarer continued, "Array has partnered with a number of venture-backed companies which continue to produce encouraging results; the venture-financed model of drug discovery and development can cost-effectively identify novel candidates and rapidly test the clinical hypothesis." The Full Research Report on Array BioPharma, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.WSReports.com/r/full_research_report/e24e_ARRY ]
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Immunomedics Inc. Research Report
On July 3, 2013, Immunomedics Inc. (Immunomedics) announced encouraging results from the Phase Ib study with clivatuzumab labeled with the radioisotope, yttrium-90 (90Y), in patients with metastatic pancreatic cancer who had received at least 2 prior treatments. Cynthia L. Sullivan, President and CEO of Immunomedics, said, "We are very encouraged with these results, and we believe this study demonstrated the feasibility of conducting clinical trials in pancreatic cancer patients relapsed to 2 or more prior treatments. We have made the strategic decision to move forward with a Phase III clinical trial, positioning clivatuzumab in this setting as a therapy for patients with advanced pancreatic cancer
who have few to no treatment options." Sullivan added, "We have designed and vetted our protocol with key opinion leaders and FDA, selected our clinical research organization, and plan to enroll the first patient into the Phase III clinical trial by the end of this calendar year, or the beginning of 2014. Most of our clinical trial sites will be in the US, with some additional sites in the EU." Sullivan concluded, "For future clinical trials, KPS and number of prior treatments will be considered as important survival prognosticators." The Full Research Report on Immunomedics Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.WSReports.com/r/full_research_report/cc0f_IMMU ]
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Cytokinetics, Incorporated Research Report
On July 8, 2013, Cytokinetics, Incorporated (Cytokinetics) announced an update on the conduct of BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS). Cytokinetics reported that over 450 patients have been enrolled in the study, which is designed to enroll up to 500 patients with ALS. The Company's primary analysis of BENEFIT-ALS will compare the mean change from baseline in the ALS Functional Rating Scale in its revised form, or ALSFRS-R (a clinically validated instrument designed to measure disease progression and changes in functional status), in patients receiving tirasemtiv versus those receiving placebo. According to Cytokinetics, the Company has already taken measures regarding the programming error in the electronic data capture system controlling study drug assignment, which caused 58 patients initially randomized to and treated with tirasemtiv to receive placebo instead at a certain study visit and for the remainder of the study. The Full Research Report on Cytokinetics, Incorporated - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.WSReports.com/r/full_research_report/5a39_CYTK ]
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SOURCE Wall Street Reports
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