NEW YORK -- The stock of Alteon Inc. lost two-thirds of its value Monday after the company said the only drug it has under clinical development failed to produce results that reached "statistical significance."
A recent Phase III trial of its kidney disease drug, pimagedine, doesn't support the submission of a new drug application to the Food and Drug Administration, the Ramsey, N.J.-based biotechnology company said.
The first trial was a five-year study of 690 patients at more than 50 clinical sites in North America.
In afternoon trading, shares of Alteon were down 68 percent, or $2.59 3/8, to $1.21 7/8 on the Nasdaq Stock Market on volume of 4.3 million shares. That's almost 30 times the average daily turnover of 146,938 shares.
OrbiMed Advisors analyst Carl Gordon said the news was "not a completely unexpected major disappointment for Alteon."
In March, the company's second trial, which tested the use of pimagedine in Type II diabetics with progressive kidney disease, was discontinued because of an increased incidence of side effects, he said.
With the latest news, Gordon said, "It looks like pimagedine is probably finished."
Alteon's chairman and chief executive, James J. Mauzey, said Alteon will further review and discuss the trial data with its corporate partner Genentech Inc., medical consultants, clinical investigators and the FDA prior to issuing a statement on the future of pimagedine.
Gordon noted that pimagedine was the only drug Alteon has in clinical development. He added that Alteon does have "some earlier programs, but nothing that was potentially near becoming a drug."