Everest Medicines Announces That Licensing Partner Immunomedics has Received FDA Accelerated Approval for Trodelvy (sacituzumab govitecan-hziy) in Previously-treated Metastatic Triple-Nega...
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
SHANGHAI, China, April 24, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by Immunomedics, Inc. (NASDAQ:IMMU) for sacituzumab govitecan-hziy (marketed as Trodelvy™ in the US) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. The approval came almost one and half months ahead of its U.S. Prescription Drug User Fee Act (PDUFA) date of June 2, 2020. In April 2019, Everest Medicines entered into an exclusive license agreement to develop, register, and commercialize Trodelvy in Greater China, South Korea and certain Southeast Asian countries and territories.
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