SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 7, 2022
bluebird bio, Inc.
(Exact name of Registrant as Specified in Its Charter)
|(State or Other Jurisdiction|
|(Commission File Number)||(IRS Employer|
455 Grand Union Boulevard,
|(Address of Principal Executive Offices)||(Zip Code)|
(Registrant’s Telephone Number, including area code: (339) 499-9300
60 Binney Street
Cambridge, MA 02142
(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):
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))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading|
|Name of each exchange on which registered|
|Common Stock, $0.01 par value per share||BLUE||The NASDAQ Stock Market LLC|
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 June 7, 2022, bluebird bio, Inc. (“bluebird” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting to review elivaldogene autotemcel (eli-cel) for early cerebral adrenoleukodystrophy in patients without a matched sibling donor and betibeglogene autotemcel (beti-cel) for the treatment of people with β-thalassemia who require regular red blood cell transfusions. The meeting is scheduled to take place on June 9-10, 2022.
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, including statements regarding the timing of the FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting. Such forward-looking statements are based on current expectations and involve inherent risks, assumptions and uncertainties, including internal or external factors that are difficult to predict, may be beyond our control and could cause our future plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks and uncertainties include, but are not limited to those described in bluebird’s most recent Annual Report on Form 10-K, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this Current Report on Form 8-K are made only as of the date of this Current Report on Form 8-K and except as otherwise required by applicable law, bluebird undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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.
|Date: June 7, 2022||bluebird bio, Inc.|
|By:||/s/ Jason F. Cole|
|Name:||Jason F. Cole|
Chief Strategy & Financial Officer, Principal Financial Officer and Principal Accounting Officer