IMMUNOMEDICS' LEAD PRODUCT HITS TROUBLE

The US Food and Drug Administration has rejected Immunomedics' application for approval of its lead product for imaging colorectal cancer, and the company's shares promptly fell 36% on the news. The product, called ImmuRAID-CEA, was developed to detect cancer left in the body after surgery. In percentage terms, the stock was the day's biggest loser on the US composite index. The company's shares had soared 68% a week previously, and a company spokesman said the surge was "all speculation," but refused to elaborate.

Immunomedics' vice president for medical affairs, Carl Pinsky, said the company will continue to work cooperatively with the FDA, and that it remains confident that the product will eventually be licensed. He would not say what problems the agency raised with the imager. Immunomedics was clearly surprised and disappointed by the development, said Edmund Debler of Mehta & Isaly, who commented that the turndown was nothing to take lightly, but rather is a severe setback for the company.

The company is developing ways of using antibodies to deliver radioisotopes both to detect and treat cancer and infectious diseases. It has two therapeutics and five imaging products in clinical trials, among them a product in Phase III to detect infections such as those in diabetic ulcers.