Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer
IMMUNOMEDICS (IMMU)
Last immunomedics earnings: 2/27 04:00 pm
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US:NASDAQ Investor Relations:
immunomedics.com/2017/immunomedics-announces-presentations-investor-event-2017-san-antonio-breast-cancer-symposium
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Source: GlobeNewswire
Prescription Drug User Fee Act (PDUFA) target action date set for June 2, 2020 MORRIS PLAINS, N.J., Dec. 26, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020. “We are pleased that the FDA has accepted our resubmission, which was a top priority for us in 2019,” said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. “We look forward to working closely with the FDA to facilitate their review of our BLA to enable us t
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