Blueprint Medicines Corporation (NASDAQ:BPMC) Files An 8-K Regulation FD Disclosure

ME Staff 8-k
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Blueprint Medicines Corporation (NASDAQ:BPMC) Files An 8-K Regulation FD Disclosure

Blueprint Medicines Corporation (NASDAQ:BPMC) Files An 8-K Regulation FD Disclosure
Item 7.01    Regulation FD Disclosure.

On June 14, 2019, Blueprint Medicines Corporation (the “Company”) issued a press release announcing the submission of a  new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (“GIST”), regardless of prior therapy, and fourth-line GIST. The Company has requested priority review for the application, 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 furnished as Exhibit 99.1 to this Current Report on Form 8-K.

On June 15, 2019, the Company announced updated data from its Phase 1 EXPLORER clinical trial evaluating avapritinib for the treatment of patients with advanced systemic mastocytosis (“SM”). The data were presented on Saturday, June 15, 2019 in an oral presentation at the 24th Congress of the European Hematology Association (“EHA Annual Meeting”) in Amsterdam, The Netherlands. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K, and a copy of the presentation is furnished as Exhibit 99.3 to this Current Report on Form 8-K.  

On June 17, 2019, the Company will host an investor call and live webcast to discuss the updated data from its Phase 1 EXPLORER clinical trial, which were presented at the EHA Annual Meeting, and its NDA submission to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and fourth-line GIST. A copy of the presentation from the investor call is furnished as Exhibit 99.4  to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, 99.2,  99.3 and 99.4, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

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Blueprint Medicines Corp Exhibit
EX-99.1 2 ex-99d1.htm EX-99.1 bpmc_Ex99_1 Exhibit 99.1   Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST   CAMBRIDGE,…
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About Blueprint Medicines Corporation (NASDAQ:BPMC)

Blueprint Medicines Corporation is a biopharmaceutical company. The Company focuses on patients with genomically defined diseases driven by abnormal kinase activation. The Company focuses on crafting drug candidates with therapeutic windows that provide clinical responses to patients without adequate treatment options. The Company has developed a small molecule drug pipeline in cancer and a genetic disease. The Company’s drug candidate, BLU-285, targets KIT Exon 17 mutants and PDGFRa D842V, which are abnormally active receptor tyrosine kinase mutants that are drivers of cancer and proliferative disorders. It is engaged in developing BLU-285 for patients with systemic mastocytosis (SM), a myeloproliferative disorder of the mast cells, and defined subsets of patients with gastrointestinal stromal tumor (GIST). Its drug candidate, BLU-554, targets FGFR4, a kinase that is aberrantly activated and is a driver of disease in a defined subset of patients with hepatocellular carcinoma (HCC).