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February 4, 2013
09:27 EDTNAVBNavidea announces collaboration with Maimonides Medical Center
Navidea Biopharmaceuticals has entered into an agreement to collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek Injection in lymphatic mapping procedures for colorectal cancer. Dr. Danny Sherwinter, surgeon and the Director of the Department of Minimally Invasive & Bariatric Surgery at Maimonides Medical Center in Brooklyn, NY, will lead the investigator-initiated clinical study. This open-label evaluation, expected to start enrollment in early 2013, will be performed at Maimondes and will include the assessment of lymph nodes from up to 40 colon cancer subjects. According to the American Cancer Society, approximately 140,000 new cases of colorectal cancer are expected to be diagnosed in the United States annually1 while worldwide annual diagnosis is over 1.2 million.
News For NAVB From The Last 14 Days
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September 26, 2014
07:29 EDTNAVBNavidea announces CHMP adopts 'positive opinion' for Lymphoseek
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September 23, 2014
07:31 EDTNAVBNavidea awarded $1.67M fast track NIH SBIR grant for evaluation of Lymphoseek
Navidea Biopharmaceuticals announced the receipt of an initial notice of award for a Fast Track Small Business Innovation Research grant providing for up to $1.67M from the National Cancer Institute, National Institutes of Health, to fund evaluation of Lymphoseek Injection in women with cervical cancer. The multicenter, clinical study in patients with early cervical cancer will seek to assess and provide data in support of the use of Lymphoseek in sentinel lymph node biopsy procedures which identify and evaluate the lymph nodes most likely to harbor additional cancer. The SBIR grant is awarded in two parts with the potential for total grant money up to a total of $1.67M over two and a half years. The first six-month funding segment of $165,917, which has already been awarded, is expected to enable Navidea to identify and qualify trial sites and secure necessary contracts and Institutional Review Board approvals. The second funding segment could provide for up to an additional $1.5M to be used to accrue participants; perform the sentinel lymph node procedures and pathology evaluations; and perform data analyses to confirm the safety and effectiveness of Lymphoseek. This study is designed as a multicenter, open-label, within-patient comparative study of Lymphoseek and an alternative lymphatic mapping agent referred to as vital blue dye for detection of lymph nodes in patients with cervical cancer. The study, using lymphatic mapping and SLN biopsy procedures, will compare the abilities of Lymphoseek and the alternative agent to identify SLNs during cervical cancer surgery. Additionally, the sentinel node pathology will be contrasted between agents and between the pathology of other nodes that may be removed during the procedure. The study is expected to involve 40 patients and last 1.5 years.
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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