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Stemline +15% on progress toward quicker FDA approval of leukemia drug

Jan. 05, 2017 5:38 PM ETStemline Therapeutics, Inc. (STML) StockBy: Carl Surran, SA News Editor1 Comment
  • Stemline Therapeutics (NASDAQ:STML) +15.4% AH after saying the FDA agreed to support an expedited registration pathway for SL-401, a treatment candidate for blastic plasmacytoid dendritic cell neoplasm, an aggressive form of leukemia which currently has no approved treatment.
  • STML says its phase 2 trial for the treatment with an additional small cohort of 8-12 patients is sufficient for full approval of a biologics license application.
  • STML plans to file the application in H2 2017; if successful, it hopes for a commercial launch in 2018.

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