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Fly News Breaks for December 20, 2018
IMMU
Dec 20, 2018 | 11:28 EDT
Wells Fargo analyst Jim Birchenough attributes this morning's pressure on Immunomedics shares to concerns regarding potential observations at the companies manufacturing facility and implications for approval of sacituzumab govitecan for triple negative breast cancer by its PDUFA date of January 18. However, after speaking to management, he said they indicated that the FDA observations occurred as part of a pre- approval inspection in early August, are "old news" and that a remediation has long been put in place. He said that the company "appears confident" in the prospects for approval of sacituzumab govitecan and maintains an Outperform rating on the stock, which remains down 23% in late morning trading.
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