Dec. 27 Company Quick Takes: Immunomedics, Qiagen, Eisai-Gilead, Melinta, Denovo-Rumpus

FDA again reviewing Immunomedics’ ADC
FDA has accepted a resubmitted BLA from Immunomedics Inc. (NASDAQ:IMMU) seeking accelerated approval of sacituzumab govitecan to treat third-line metastatic triple-negative breast cancer. The company had received a complete response letter in January because of CMC concerns. The antibody-drug conjugate, which comprises an antibody against EGP-1 conjugated with SN-38, has a PDUFA date of June 2, 2020. Everest Medicines Ltd. holds the ADC’s rights in several Asian territories (see “Everest Bolsters Cancer Pipeline”).

Qiagen declines takeout offers ...