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FDA delays approval of Immunomedics' ADC for triple-negative breast cancer
January 18, 2019 2:04 PM UTC
Immunomedics Inc. (NASDAQ:IMMU) said FDA issued a complete response letter for its BLA for sacituzumab govitecan (IMMU-132) to treat metastatic triple-negative breast cancer in a third-line setting. The company was seeking accelerated approval of the antibody-drug conjugate, which was under Priority Review.
Shares of Immunomedics were off $4.78 (26%) to $13.31 for a loss of more than $900 million in market cap...
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