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News Breaks
February 18, 2014
07:36 EDTNAVBNavidea announces priority review for sNDA to expand Lymphoseek labeling
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Supplemental New Drug Application and granted a Priority Review for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act, the FDA has set a target review date for the Lymphoseek sNDA of June 16. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
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September 18, 2014
18:25 EDTNAVBOn The Fly: After Hours Movers
HIGHER: Concur (CNQR), up 19.5% after SAP (SAP) announced that it will acquire the company for $129 per share... Navidea Biopharmaceuticals (NAVB), up 9.8% after confirming FDA orphan designation for Lymphoseek... Molycorp (MCP), up 6.1% after Oaktree Capital reported a 9.1% passive stake in the company... JetBlue (JBLU), up 4.6% following CEO transition announcement... Wendy's (WEN), up 2.15% after Trian reported a 24.39% stake in the company... Sears Holdings (SHLD), up 2.6% after Fairholme Capital reported a 24% stake in the company... AMD (AMD), up 1% after announcing that it expanded an IP partnership with Synopsys (SNPS). DOWN AFTER EARNINGS: Red Hat (RHT), down 3%... Oracle (ORCL), down 2.4% following first quarter earnings miss and CEO transition... Tibco Software (TIBX), down 5.5%. ALSO LOWER: Quest Resource (QRHC), down 13.4% after filing an automatic common stock and warrant shelf... Eagle Rock (EROC), down 4.5% after filing to sell 53.34M common units for limited partners... Chatham Lodging (CLDT), down 3.3% after filing to sell 5M shares of common stock... Glu Mobile (GLUU), down 2.3% after filing to sell 9.98M shares of common stock for holders... Blackstone Mortgage (BXMT), down 1.6% after filing to sell 8M shares of common stock.
16:10 EDTNAVBNavidea confirms FDA orphan designation for Lymphoseek in head, neck cancers
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11:07 EDTNAVBNavidea granted orphan status for tilmanocept injection
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