UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): December 21, 2018
Stemline Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware |
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001-35619 |
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45-0522567 |
750 Lexington Avenue
Eleventh Floor
New York, New York 10022
(Address of Principal Executive Offices)
(646) 502-2311
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act.
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
o Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 8.01 Other Events.
On December 21, 2018, Stemline Therapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration has granted approval of ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD-123 targeted therapy.
The Company intends to host a conference call to discuss the approval of ELZONRIS for the treatment of BPDCN on Friday, December 21, 2018, at 4:30 p.m. EST. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
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Exhibit Number |
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Description |
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99.1 |
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Press release issued by Stemline Therapeutics, Inc., dated December 21, 2018. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: December 21, 2018 |
Stemline Therapeutics, Inc. | |
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(Registrant) | |
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By |
/s/ Kenneth Hoberman |
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Kenneth Hoberman |
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Chief Operating Officer |