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Stemline Therapeutics (STML) EU Orphan Drug Designation for Treatment of BPDCN with SL-401

November 2, 2015 8:16am

The European Medicines Agency (EMA) has granted Orphan Drug designation to SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Recently, SL-401 received Orphan Drug designation from the EMA for acute myeloid leukemia (AML), and from the U.S. Food and Drug Administration (FDA) for the treatment of AML and BPDCN.

The Bottom Line; SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. STML is evaluating SL-401 in multiple clinical programs, including an ongoing pivotal trial in BPDCN as well as trials in additional hematological cancers.

STML had closed at $8.89 which was UP +$0.20 on 10/30. Woe are the days of July and the “teens”

SL-401 now has Orphan Drug status in the U.S. and Europe for both AML and BPDCN.

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