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 3, 2018

 

bluebird bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Registrant’s Telephone Number, Including Area Code: (339) 499-9300

Not Applicable

(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 (see General Instructions A.2. below):

Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ☐

 

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Item 7.01Regulation FD Disclosure.

 

On December 3, 2018, bluebird bio, Inc. (“bluebird”) conducted an investor webcast presenting updated clinical data for the LentiGlobin product candidate in the treatment of patients with transfusion-dependent β-thalassemia (HGB-204, HGB-207, and HGB-212), for the LentiGlobin product candidate in the treatment of patients with sickle cell disease (HGB-206), and for the bb21217 product candidate in the treatment of patients with relapsed-refractory multiple myeloma (CRB-402), as presented at the 60th Annual Meeting of the American Society of Hematology (“ASH”) in San Diego, CA. A copy of the presentation is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 8.01Other Events.

 

On December 3, 2018, bluebird issued a press release announcing data presented at ASH from the Phase 3 Northstar-2 (HGB-207) and Phase 3 Northstar-3 (HGB-212) clinical studies of its investigational LentiGlobin product candidate in patients with transfusion-dependent β-thalassemia.

 

Also on December 3, 2018, bluebird issued a press release announcing data presented at ASH from patients in Group C of its ongoing Phase 1/2 HGB-206 study of its investigational LentiGlobin product candidate in patients with sickle cell disease.

 

The full text of bluebird’s press releases regarding these announcements are filed as Exhibits 99.2 and 99.3 to this Current Report on Form 8-K and are incorporated herein by reference.

 

Item 9.01Financial Statements and Exhibits.

(d) Exhibits

 

 

 

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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.