Stemline Therapeutics Reports Second Quarter 2018 Financial Results
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, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced today its financial results for the quarter ended June 30, 2018. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones: ELZONRIS™ (SL-401, tagraxofusp) – BLA submission completed We completed submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ELZONRIS, which has been granted breakthrough therapy designation (BTD), for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). If successful, we anticipate acceptance of our BLA within 60 days of submission (i.e. in the coming weeks) and potential U.S. marketing approval by 1Q19, or possibly sooner.Data from our pivotal trial in patients with BPDCN was the subject of an oral presentation at the 23rd Congress of the European
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