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July 16, 2014
07:37 EDTNAVBNavidea forms joint enterprise with Rheumco
Navidea announced that it has formed a joint enterprise with Essex Woodlands-backed Rheumco to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, will combine Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need. R-NAV will be initially funded primarily through a $4M investment from Infinity Capital III and other third-party private investors working closely with Essex Woodlands, and underpinning the technology contributions from Rheumco and Navidea. Navidea has committed an additional $1M to support R-NAV’s development efforts to be paid in equal installments over three years. In exchange for its cash, in-kind and technology contributions, Navidea has received both common units and Preferred Series A units of R-NAV and will initially own approximately 30% of the combined entity. Joint oversight of R-NAV is shared between Navidea, Rheumco, Infinity Capital III of Houston-based McRay Money Management, and the other investors. Navidea also has an option to acquire, at its sole discretion prior to Phase 3 clinical study, imaging products derived from the Manocept platform, and therapeutic products combining Manocept agents from Navidea with the Tin-117m technology for commercialization.
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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.

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