Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer

MORRIS PLAINS, N.J., Feb. 5, 2009 -- (HSMN NewsFeed) -- Immunomedics, Inc. (NasdaqGM:IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) granting yttrium-90-labeled hPAM4 Fast Track designation for the treatment of pancreatic cancer.

The fast track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The fast track designation allows for close and frequent interaction with the agency. A designated fast track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.

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