Navidea Dives as FDA Rejects Product to Identify Cancers

Navidea Biopharmaceuticals Inc. (NAVB) plummeted as much as 36 percent after regulators rejected the company’s product designed to help identify lymph nodes that have the highest probability of being cancerous.

Navidea declined to $2.23 in extended trading at 4:25 p.m. New York time after closing at $3.51. The company’s shares rose 19 percent in the past 12 months.

The failure to approve Lymphoseek, Navidea’s radiopharmaceutical, is related to third-party contract manufacturers, not the safety or efficacy data filed with the Food and Drug Administration, the Dublin, Ohio-based company said today in a statement. Lymphoseek, an injectable chemical, has been studied in mapping procedures performed on breast cancer and melanoma patients.

“We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible” application “resubmission and review,” Mark Pykett, president and chief executive officer of Navidea, said in the statement. “We remain confident that our clinical data clearly demonstrate the value of Lymphoseek.”

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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