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Stock Market & Financial Investment News

News Breaks
January 30, 2013
09:12 EDTNAVBNavidea Biopharmaceuticals 1.542M share Secondary priced at $3.10
Ladenburg acted as sole book running manager for the offering.
News For NAVB From The Last 14 Days
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November 20, 2014
07:31 EDTNAVBNavidea granted marketing authorization for Lymphoseek by European Commission
Navidea Biopharmaceuticals has announced that the European Commission has granted marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation. Lymphoseek is now approved in the European Union for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. The sentinel node detection label in Europe may now allow Lymphoseek to be used in approximately 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers diagnosed in Europe annually, respectively. Lymphoseek is approved in the U.S. for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
November 11, 2014
07:31 EDTNAVBNavidea receives $1.1M PDUFA filing free refund for award of orphan drug status
Navidea Biopharmaceuticals announced it has received a $1.1M refund of the previously paid Prescription Drug User Fee Act filing fee related to the granting of orphan drug status of Lymphoseek injection in head and neck cancers. Lymphoseek was granted Orphan Drug Designation by the FDA in September 2014 for use in sentinel lymph node detection in patients with cancer of the head and neck. Additionally, Platinum Partners, Navidea’s major investor, reaffirmed its support of the company through the remaining $31.8M available under the previously announced line of credit. “We believe we have sufficient capital resources to attain our immediate goals and realize the full commercial potential for Lymphoseek,” said Rick Gonzalez, Navidea CEO. “We are in a position to manage our available cash with our expected growth in revenue and gross profit, our ability to further reduce our operating costs and, if needed, our access to capital under the line of credit from Platinum Partners.”

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