Stemline Therapeutics Announces that FDA Accepts ELZONRIS™ Biologics License Application (BLA) and Grants Priority Review
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
Conference call on BLA acceptance and commercial readiness scheduled for Monday, August 13, 2018 at 8:30 AM ET NEW YORK, Aug. 13, 2018 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA also granted Priority Review for the BLA and has set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA). The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. ELZONRIS has also been granted Breakthrough
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