New User:

Forgot your password?

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
Sign up for a free trial to see the rest of the stories you've been missing.
December 15, 2014
13:12 EDTNAVBNavidea's Macrophage unit announces presentation of data using tilmanocept
Macrophage Therapeutics, a newly created business unit of Navidea Biopharmaceuticals, hosted a conference where data was presented using Manocept platform compound, tilmanocept, that was generated by independent academic collaborators with expertise in the HIV/AIDS, cancer, tuberculosis, rheumatoid arthritis and cardiovascular disease therapeutic areas. The technical presentations highlighted tilmanocept’s ability to target activated macrophages implicated in pathology. Specifically data were presented in: 1. Kaposi’s Sarcoma cells from human tumor extracts that contain tumor associated macrophages and are often infected with HIV. Data demonstrated that a generic anticancer agent that has no direct activity vs. HIV, conjugated to tilmanocept killed the CD-206 positive TAM’s. 2. Tilmanocept labeled with a fluorescent reporter demonstrated a high degree of co-localization with tuberculosis-associated activated macrophages, which express CD-206, from TB granulomas extracted from human and primate tissue. 3. Rheumatoid Arthritis - Data presented indicated that tilmanocept containing a florescent reporter molecule demonstrates selective localization solely into rheumatoid affected joints in a whole live animal model of RA. Navidea director Michael M. Goldberg, M.D., who is leading Navidea’s Macrophage Therapeutics efforts, commented, “the data presented today will shortly be enhanced by data from ongoing studies to further advance this novel immunotherapy approach. We are in the process of assembling a world class Scientific Advisory Board that will assist in guiding our research further. We look forward to regularly updating the market with new developments, potential partnerships and results from our ongoing studies.”
09:28 EDTNAVBNavidea trading halted, pending news
Subscribe for More Information
December 10, 2014
07:32 EDTNAVBNavidea forms Macrophage Therapeutics business unit
Navidea Biopharmaceuticals announced the formation of a new business unit, Macrophage Therapeutics, to further explore therapeutic applications for the Manocept platform. The Manocept platform serves as the molecular backbone of Navidea’s FDA-approved, activated macrophage-targeting agent, Lymphoseek injection. Preclinical data being developed by the company using tilmanocept linked to various therapeutic agents suggest that tilmanocept’s binding affinity to CD206 receptors demonstrates the potential for this technology to be useful in treating diseases linked to the over-activation of macrophages. This includes various cancers as well as autoimmune, infectious, cardiovascular, and central nervous system diseases. Navidea intends to structure Macrophage Therapeutics such that it will remain under Navidea’s control enabling existing shareholders to capture potential future value, but also allow funding of future development in a standalone, non-dilutive manner to Navidea’s existing shareholders. Current board members Michael M. Goldberg, M.D. and Eric K. Rowinsky, M.D. and Navidea’s Chief Scientific Officer, Frederick O. Cope, Ph.D. have been appointed to focus on the launch of the new unit.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use