SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Item 8.01 Other Events.
On December 17, 2020, Blueprint Medicines Corporation (the “Company”) issued a press release announcing the submission of a supplemental new drug application (“sNDA”) to the U.S. Food and Drug Administration (“FDA)” for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis. The Company has requested priority review for the sNDA, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101)
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.
BLUEPRINT MEDICINES CORPORATION
Date: December 17, 2020
Jeffrey W. Albers
Chief Executive Officer