Stemline Therapeutics,Inc. (NASDAQ:STML) Files An 8-K Other Events

Stemline Therapeutics,Inc. (NASDAQ:STML) Files An 8-K Other Events
Item 8.01 Other Events.

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On August13, 2018, Stemline Therapeutics,Inc. announced 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 February21, 2019, under the Prescription Drug User Fee Act (PDUFA).

A copy of the press release is being furnished as Exhibit99.1 to this report.

Item 9.01. Financial Statements and Exhibits.


The following exhibit is furnished herewith:

EX-99.1 2 a18-18724_1ex99d1.htm EX-99.1 Exhibit 99.1     Stemline Therapeutics Announces that FDA Accepts ELZONRISTM Biologics License Application (BLA) and Grants Priority Review   ·                  Conference call on BLA acceptance and commercial readiness scheduled for Monday,…
To view the full exhibit click here

About Stemline Therapeutics,Inc. (NASDAQ:STML)

Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing oncology therapeutics. The Company is developing approximately three clinical stage product candidates, including SL-401, SL-701 and SL-801. SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) (CD123), present on a range of hematologic cancers. SL-401 consists of IL-3 recombinantly fused to a truncated diphtheria toxin payload. SL-701 is an immunotherapy designed to activate the immune system to attack tumors. SL-701 comprises various short synthetic peptides that correspond to epitopes of targets, including IL-13 receptor subunit alpha-2 (IL-13Ra2), ephrin type-A receptor 2 (EphA2) and survivin, present on brain cancer. SL-801 is an oral, small molecule that reversibly inhibits Exportin-1 (XPO1), also known as Chromosome Region Maintenance-1 (CRM-1), a nuclear transport protein.

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