8-K 1 d723476d8k.htm 8-K 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): March 14, 2019

Karyopharm Therapeutics Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware    001-36167    26-3931704
(State or Other Jurisdiction of

Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

85 Wells Avenue, 2nd Floor
Newton, Massachusetts
   02459
(Address of Principal Executive Offices)    (Zip Code)

Registrant’s telephone number, including area code: (617) 658-0600

(Former Name or Former Address, if Changed Since Last Report)

 

 

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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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   ☐        

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.  ☐


Item 8.01.

Other Events.

On March 14, 2019, Karyopharm Therapeutics Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) extended from April 6, 2019 until July 6, 2019 the Prescription Drug User Fee Act (PDUFA) action date for the Company’s new drug application (NDA) seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. The Company submitted additional, existing clinical information as an amendment to the NDA, which allowed the FDA to extend the PDUFA action date by three months.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d)         Exhibits

 

99.1    Press release issued by Karyopharm Therapeutics Inc. on March 14, 2019


SIGNATURES

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.

 

    KARYOPHARM THERAPEUTICS INC.
Date: March 15, 2019     By:   /s/ Christopher B. Primiano
     

 

      Christopher B. Primiano
     

Executive Vice President, Chief Business

Officer, General Counsel and Secretary