KARYOPHARM THERAPEUTICS INC. FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits

Edgar Glimpses |

Item 8.01. Other Events.

On , Karyopharm Therapeutics Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) extended from until 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 


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