Stemline Therapeutics,Inc. (NASDAQ:STML) Files An 8-K Other EventsItem 8.01 Other Events.
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:
STEMLINE THERAPEUTICS INC ExhibitEX-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
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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