Changes in Senior Management, Grants of Orphan Drug Designations, and Updates on Pipeline Development and NDA - Research Report on Vivus, Omeros, Delcath Systems, Achillion, and Zogenix
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NEW YORK, October 7, 2013 /PRNewswire/ --
Today, Analysts' Corner announced new research reports highlighting VIVUS Inc. (NASDAQ: VVUS), Omeros Corporation (NASDAQ: OMER), Delcath Systems, Inc. (NASDAQ: DCTH), Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), and Zogenix, Inc. (NASDAQ: ZGNX). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
VIVUS Inc. Research Report
On September 27, 2013, VIVUS, Inc. (Vivus) announced the resignation of Peter Y. Tam as the Company's President, effective October 12, 2013. The Company mentioned that in Mr. Tam's 20 year tenure at VIVUS, he held a broad range of key management and leadership roles, and was directly responsible for the efforts to secure the rights, develop and gain approval for four of the Company's products. "We thank Peter for his invaluable contributions to VIVUS during two decades of successful service," stated Seth Fischer, CEO of VIVUS. "Among his many achievements, Peter completed the in-licensing of Qsymia and STENDRA, and led their subsequent development and approvals. We wish him every success in his future endeavors." 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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Omeros Corporation Research Report
On September 30, 2013, Omeros Corp. (Omeros) announced that it has received an orphan drug designation from the U.S. Food & Drug Administrator (FDA) for OMS824, the Company's phosphodiesterase 10 (PDE10) inhibitor. According to Omeros, the PDE10 inhibitor is for the treatment of Huntington's disease. "The manifestations of Huntington's are devastating to both Huntington's patients and their families, yet there is only one currently approved therapeutic and it is focused on a single symptom of the disease. OMS824 holds the promise of expanding treatment across the constellation of debilitating effects of Huntington's," stated Gregory A. Demopulos, M.D., Chairman and CEO of Omeros. "We look forward to working with the FDA to advance the clinical evaluation of OMS824 in patients suffering from Huntington's disease and plan to initiate enrollment in a Phase 2 trial later this year." The Full Research Report on Omeros Corporation - 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/e3c9_OMER]
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Delcath Systems, Inc. Research Report
On October 1, 2013, Delcath Systems, Inc. (Delcath Systems) announced that the US Food & Drug Administration (FDA) has granted the Company orphan drug designation for melphalan in the treatment of patients with hepatocellular carcinoma (HCC, or primary liver cancer). According to the Company, the designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. The Company informed that the use of Melphalan with the Delcath Hepatic Delivery System is not currently approved in the United States for the treatment of patients with HCC. The Full Research Report on Delcath 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/be47_DCTH]
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Achillion Pharmaceuticals, Inc. Research Report
On September 27, 2013, Achillion Pharmaceuticals, Inc. (Achillion) announced updates in the development of compounds in its pipeline of therapies for the treatment of chronic hepatitis C virus, or HCV. The Company received a response from the US Food & Drug Administration (FDA) on the clinical hold related to sovaprevir, Achillion's NS3 protease inhibitor, which indicated that while Achillion's submission addressed all issues noted in the FDA's June 29, 2013 letter, the FDA concluded that the removal of the clinical hold is not warranted. "While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens for the treatment of HCV," stated Milind Deshpande, President and CEO of Achillion. "With our Phase 2 NS5A inhibitor, ACH-3102, we are in a position to rapidly initiate combination studies with ACH-2684, our protease inhibitor, with results expected in 2014. Further, we continue to advance our uridine-analog nucleotide, ACH-3422, with which we anticipate initiating clinical trials in the first half of 2014." The Full Research Report on Achillion 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/04a2_ACHN]
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Zogenix, Inc. Research Report
On October 1, 2013, Zogenix Inc. (Zogenix) announced that the US Food & Drug Administration (FDA) has informed the Company that an action letter on the New Drug Application (NDA) for Zohydro[TM] ER (hydrocodone bitartrate) extended-release capsules could follow after a further delay of short duration. The FDA had previously informed the Company that it expected to issue an action letter over the summer. The Company said that if approved, Zohydro ER is expected to be the first extended-release formulation hydrocodone therapy without acetaminophen. The Full Research Report on Zogenix, 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/ef36_ZGNX]
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