The era of the monoclonal antibody is clearly still not with us. At the end of August, the FDA turned down application for approval of Bexxar, a monoclonal antibody linked to a radioisotope for the treatment of low-grade B-cell non-Hodgkin's lymphoma. The FDA is not seeking new clinical trial data, but it does want the Biologics License Application (BLA) submission reanalyzed and reformatted. Nevertheless, shares of Coulter Pharmaceuticals (Palo Alto, CA), which is developing the drug in conjunction with SmithKline Beecham, dropped 31% the day following the announcement, closing at $23.50. Since Coulter's product portfolio is relatively small, its future is linked to Bexxar, its most advanced candidate (Nat. Biotechnol. 16, 1000, 1998). By the end of this month the company plans to submit the amended BLA, which will take six months to priority review. In the meantime, Coulter's rival, Idec Pharmaceuticals (San Diego, CA), saw its share price drop 23% (to $105.44) after announcing that the third quarter sales of Rituxan—a naked monoclonal for treatment of non-Hodgkin's lymphoma—are unlikely to reach the high end of its $70–$80 million target.