NEW YORK (CNN/Money) - Shares of biotech Corixa Corp. fell more than 37 percent Wednesday afternoon after the Food and Drug Administration rejected the company's application to market a cancer drug.

Corixa (CRXA: down $3.48 to $6.15, Research, Estimates) said it received a letter from the FDA that said data for Bexxar, a low-grade non-Hodgkin's lymphoma treatment, did not "provide sufficient evidence of the safety and net clinical benefit" of the drug and that new clinical trials would be needed.

"We are extremely disappointed with the FDA's decision and intend to promptly pursue the resolution with our partner, GlaxoSmithKline and the agency," said Steven Gillis, Corixa chairman and CEO, in a statement. "We are formally requesting a meeting with the FDA and hope to reach mutual agreement on the specific steps still necessary for approval."

The Seattle-based company said it plans to meet with the FDA within 45 days.

According to Corixa, the FDA also decided there was not enough evidence to prove Bexxar addresses an unmet medical need, eliminating the possibility of fast-track approval.

Paul Latta, analyst with McAdams Wright Regan, said its unclear what additional clinical information the FDA will require, making it hard to estimate how long it would take for Bexxar to be approved.

"Right now there's just not a lot of information," Latta said.

The FDA decision is the latest setback for Bexxar, which showed promise in late 2000 and was granted priority review while it was being developed by biotech Coulter Pharmaceutical Inc. and SmithKline Beecham PLC.

Bexxar is designed to treat relapsed or low-grade B-cell non-Hodgkin's lymphoma, a form of cancer that affects the blood and lymphatic tissues. If approved, it could be the first approved radioimmunotherapy drug to go on the market.

The drug was on track for approval by early to mid-2001 when Corixa agreed to buy Coulter, including the rights to Bexxar. Corixa completed the deal in December 2001, paying $629 million in stock.

But the FDA required more information in March 2001, which Corixa supplied six months later.

Latta said the company still collectively has a lot of programs and partners, although none in as late a stage as Bexxar, and he feels the stock is now "a little oversold."