Marketing Approvals, Disposal of Interests, Positive Study Results and New Clinical Trials - Research Report on Cardiovascular Systems, Depomed, Halozyme, VIVUS, and Gentium
NEW YORK, October 25, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Analysts' Corner announced new research reports highlighting Cardiovascular Systems Inc. (NASDAQ: CSII), Depomed Inc. (NASDAQ: DEPO), Halozyme Therapeutics, Inc. (NASDAQ: HALO), VIVUS Inc. (NASDAQ: VVUS), and Gentium S.p.A (NASDAQ: GENT). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Cardiovascular Systems Inc. Research Report
On October 22, 2013, Cardiovascular Systems Inc. (Cardiovascular Systems) announced that it has received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360® Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries. David L. Martin, President and CEO of Cardiovascular Systems said, "Today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI. FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades." The Full Research Report on Cardiovascular Systems 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/11b9_CSII]
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Depomed Inc. Research Report
On October 21, 2013, Depomed Inc. (Depomed) announced that it has sold its interests in royalty and milestone payments under its license agreements in the Type 2 diabetes therapeutic area to PDL BioPharma, Inc. for $240.5 million. The Company stated that it plans to utilize the sale proceeds to acquire products that will drive long-term growth and build on the Company's commercial expertise in pain and neurology. Jim Schoeneck, President and CEO of Depomed said, "Through this sale of our Type 2 diabetes milestone and royalty payments, we have generated a significant infusion of cash equal to approximately 55 percent of our market capitalization without issuing any equity or incurring any debt. Importantly, we have retained our royalty and milestone interests in our other collaborations, including agreements with Mallinckrodt for MNK 795 and MNK 155, with Janssen for Nucynta ER® (tapentadol extended-release tablets) and with Ironwood." The Full Research Report on Depomed 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/edda_DEPO]
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Halozyme Therapeutics, Inc. Research Report
On October 22, 2013, Halozyme Therapeutics, Inc. (Halozyme) announced the beginning of a Phase 1b/2 randomized clinical trial (S1313) of its investigational drug, PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) compared to mFOLFIRINOX treatment alone in patients with metastatic pancreatic adenocarcinoma. According to the Company, the trial is being sponsored by SWOG -a cancer research cooperative group, and will enroll about 144 patients. Gregory I. Frost, Ph.D., President and CEO, Halozyme Therapeutics, said, "Despite recent advancements, pancreatic cancer still has one of the lowest survival rates of any malignancy. The S1313 trial, coupled with our internally sponsored Phase 2 trial of PEGPH20 in combination with nab-paclitaxel and gemcitabine, will provide important safety and efficacy data on the potential of PEGPH20 in combination with the most advanced chemotherapeutic regimens available to patients with pancreatic cancer today." The Full Research Report on Halozyme Therapeutics, 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/ea1b_HALO]
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VIVUS Inc. Research Report
On October 8, 2013, VIVUS Inc. (VIVUS) announced new data published online in "Diabetes Care" which revealed the effects of Qsymia® (phentermine and topiramate extended-release) capsules CIV, on the progression to type 2 diabetes. According to the Company, the publication analyzed 475 high-risk overweight or obese patients with prediabetes and/or metabolic syndrome at baseline from the two-year SEQUEL study, for their progression to type 2 diabetes and their changes in cardiometabolic parameters. VIVUS informed that after 108 weeks, it was observed that patients receiving Qsymia, in conjunction with lifestyle modifications, experienced significant weight loss along with markedly reduced progression to type 2 diabetes and improvements in multiple cardiometabolic disease risk factors. The Full Research Report on VIVUS 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/8ae9_VVUS]
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Gentium S.p.A Research Report
On October 22, 2013, Gentium S.p.A's (Gentium) announced that the European Commission has granted a Marketing Authorization for Defitelio® (defibrotide) for the treatment of severe hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy. According to the Company, the authorization is the formal endorsement of the positive opinion received from the European Medicine Agency's (EMA) Committee for Human Medicinal Product (CHMP) on July 26, 2013. The Company stated that it plans to initiate commercialization of Defitelio® in the European Union in December 2013. Dr. Khalid Islam, Chairman and CEO of Gentium stated, "Today's authorization of Defitelio® represents an important milestone for Gentium. As the first drug to be approved for the treatment of severe VOD, Defitelio® will provide physicians with a life-saving option addressing a high unmet medical need for a disease with a high mortality rate, in excess of 80%. Gentium is proud of this achievement, which we believe will provide comfort and hope for patients and their families." The Full Research Report on Gentium S.p.A - 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/e100_GENT]
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SOURCE Analysts' Corner
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