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Stock Market & Financial Investment News

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.
News For NAVB From The Last 14 Days
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February 18, 2015
10:54 EDTNAVBNavidea says Lymphoseek data reinforces clinical value in certain cancers
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February 17, 2015
09:20 EDTNAVBOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Vipshop Holdings (VIPS), up 10.9%... VASCO Data Security (VDSI), up 7.1%... Waste Management (WM), up 3.7%. ALSO HIGHER: Starwood Hotels (HOT), up 1.9% after appointing Adam Aron as interim CEO... Sarepta Therapeutics (SRPT), up 7.3% after being upgraded at BofA/Merrill... Navidea Biopharmaceuticals (NAVB), up 7.5% after publishing results of phase 3 Lymphoseek trial... Campus Crest (CCG), up 7.7% after announcing that it will explore strategic alternatives as well as Clinton Group and Campus Evolution proxy contest... Cyren (CYRN), up 7.1% following distribution agreement with ALSO Deutschland. DOWN AFTER EARNINGS: Helix Energy (HLX), down 13.3%... Walter Energy (WLT), down 10.1%. ALSO LOWER: Celsus Therapeutics (CLTX), down 82.3% after MRX-6 Cream 2% Phase II trial did not meet primary endpoint... Vascular Biogenics (VBLT), down 53.2% after reporting that VB-201 Phase 2 studies did not meet primary endpoints and removal of FDA partial clinical hold on VB-111... Vanguard Natural Resources (VNR), down 7.1% after reporting preliminary fourth quarter results.
07:37 EDTNAVBNavidea publishes results of phase 3 Lymphoseek trial
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