Stemline Therapeutics Announces that Pivotal Trial of SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Meets Primary Endpoint
STEMLINE THERAPEUTICS (STML)
Last stemline therapeutics earnings: 3/13 04:45 pm
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Source: GlobeNewswire
Detailed results will be presented at the ASH 2017 Annual Meeting (Dec. 9-12)Based on FDA feedback, BLA filing remains on-track Conference call scheduled for today, Tuesday, October 31, 2017 at 8:30AM ET NEW YORK, Oct. 31, 2017 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, announced today that the pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has met its primary endpoint. Based on feedback from the U.S. Food and Drug Administration (FDA), Stemline remains on track to begin submission of its Biologics License Application (BLA) in the 4Q17-1Q18 timeframe. SL-401 has been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of BPDCN, and Orphan Drug Designation (ODD) by the FDA and EU for the treatment of patients with BPDCN and acute myeloid leukemia (AML). Pivotal TrialThe pivotal Phase 2 trial of
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