12/16 12:21
VaxGen Shares Rise on Expedited Review for HIV Vaccine
By Angela Zimm
Brisbane, California, Dec. 16 (Bloomberg) -- VaxGen Inc. shares rose as much as 22 percent after the company said U.S. regulators designated its experimental HIV vaccines for fast review.
The shares rose $2.48 to $15.49 as of 12:01 p.m. New York time on the Nasdaq Stock Market after reaching $15.85.
The Food and Drug Administration agreed to consider VaxGen's AIDSVAX B/B and AIDSVAX B/E under a program designed to speed review of drugs for life-threatening diseases, VaxGen said in a statement. VaxGen's vaccines against the virus that causes AIDS are being studied in the last of three stages of human testing generally required for FDA approval.
VaxGen may submit portions of its vaccine applications for FDA review instead of having to wait until it compiles complete data. Once VaxGen has turned in complete information, it may ask the FDA to review the applications in six months instead of the typical 12 months, said VaxGen spokesman Jim Key.
``We're confident we'll receive priority review,'' Key said.
Brisbane, California-based VaxGen said it expects to release results of its AIDSVAX B/B study in the first quarter of 2003 and AIDSVAX B/E results in the second half of the year.
VaxGen's AIDSVAX products are the most advance HIV vaccines in development.
The vaccines work by triggering the body's immune system to make antibodies that
prevent the virus from attaching to healthy cells.
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