(Reuters) - Navidea Biopharmaceuticals Inc’s shares fell as much as 17 percent on Friday after a negative report on TheStreet.com despite the company receiving expanded U.S. approval for its imaging agent.
The U.S. Food and Drug Administration on Friday approved Navidea’s imaging agent, Lymphoseek, to help physicians determine the extent of head and neck cancer.
Lymphoseek was approved in the United States last year in injectable form in patients with breast cancer or melanoma.
The radioactive agent can now be used to guide the testing or biopsy of lymph nodes closest to the primary tumor in patients with cancer of the head and neck, the FDA said. (link.reuters.com/keb22w)
The report on TheStreet.com said that Navidea's effort to expand approval of Lymphoseek into head-and-neck cancer was "meaningless" because there is no outcomes data to support these tests - known as sentinel lymph node biopsies - in this cancer indication. (r.reuters.com/dyb22w)
A sentinel lymph node is the first lymph node to which cancer cells are most likely to spread from a primary tumor.
“An expanded approval, if it happens, will generate inconsequential additional revenue,” TheStreet.com quoted an institutional investor as saying.
Dublin, Ohio-based Navidea’s stock was down 7 percent at $1.77 in early afternoon trading on the American Stock Exchange.
Reporting by Natalie Grover in Bangalore; Editing by Maju Samuel