Stemline Therapeutics Announces Submission of European Marketing Authorization Application (MAA) for ELZONRIS™
STEMLINE THERAPEUTICS (STML)
Last stemline therapeutics earnings: 3/13 04:45 pm
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US:NASDAQ Investor Relations:
ir.stemline.com/investor-relations
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Source: GlobeNewswire
NEW YORK, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that it has submitted the marketing authorization application (MAA) for ELZONRIS (tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment. On December 21, 2018, ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) for the treatment of BPDCN in adult and pediatric patients, two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy. “The submission of the ELZONRIS MAA is another major step forward for providing this important targeted treatment to patients, glob
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