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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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October 15, 2014
09:20 EDTNAVBOn The Fly: Pre-market Movers
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08:03 EDTNAVBNavidea names Gonzalez CEO
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08:01 EDTNAVBNavidea names Gonzalez CEO
07:03 EDTNAVBNavidea announces FDA sNDA approval for Lymphoseek extended use
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has approved the Supplemental New Drug Application for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek will be immediately available using existing reimbursement codes for this expanded population of cancer patients. In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.

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