MORRIS PLAINS, N.J., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today reported financial results for the fourth quarter and fiscal year ended June 30, 2017. The Company also highlighted recent key developments and planned activities for its clinical pipeline. Please refer to the Company’s Annual Report on Form 10-K filed today with the SEC for more detail on the Company’s financial results.
Dr. Behzad Aghazadeh, Chairman of the Board of Directors of Immunomedics, stated, “We believe we have made significant progress toward preparing a Biologics License Application (BLA) for filing with the U.S. Food and Drug Administration (FDA) for accelerated approval of IMMU-132 in metastatic triple-negative breast cancer (mTNBC). To that end, we have made advancements in all areas, including clinical, regulatory, and manufacturing, and we expect to receive clarification during a pre-BLA meeting with the FDA on the level of Chemistry, Manufacturing & Controls (CMC) process validation required at the time of the BLA submission. Importantly, our continued evaluation of the clinical data and manufacturing processes, as well as the progress over the past several months, have further strengthened our confidence in the prospects for IMMU-132 in mTNBC. We look forward to submitting the BLA between December 2017 and March 2018, which along with business development opportunities, should enable us to generate significant value for our stockholders.”
