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FDA Declines to OK Navidea Cancer Imaging Agent

From Associated Press (September 10, 2012)

DUBLIN, Ohio -- Navidea Biopharmaceuticals Inc. said Monday that the Food and Drug Administration did not approve its cancer imaging agent Lymphoseek because of problems with third-party manufacturers.

Navidea said it is working with the FDA to resolve those manufacturing problems and plans to resubmit its application as quickly as possible and ensure a prompt review.

Shares of Navidea plunged $1.31, or 37.3 percent, to $2.20 in aftermarket trading.

Lymphoseek is a radioactive imaging agent that is used to help determine if breast cancer or melanoma has spread to a patient’s lymph nodes. Navidea said Lymphoseek can identify the lymph nodes that drain from a primary tumor. Those lymph nodes have the highest probability of harboring cancer.

Navidea stock rose as much as 6.7 percent during the day as Wall Street anticipated Lymphoseek would be approved. However the stock relinquished those gains and closed down 6 cents at $3.51.

Rodman & Renshaw analyst Michael King said Lymphoseek appears to be more accurate and convenient than older imaging agents. He said it could be used in the evaluation of more than a million newly-diagnosed tumors per year in the U.S. and a total of 8 million worldwide. King added Cardinal Health Inc. will help distribute Lymphoseek when it is approved, and Cardinal is one of the largest marketers of radiopharmaceutical products in the U.S.

Posted: September 2012