Item 8.01 Other Events.
On July 29, 2020, bluebird bio, Inc. ("bluebird") and Bristol Myers Squibb
Company issued a press release announcing the resubmission of a Biologics
License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the
product candidate idecabtagene vicleucel (ide-cel; bb2121) for the treatment of
adult patients with multiple myeloma who have received at least three prior
therapies, including an immunomodulatory agent, a proteasome inhibitor and an
anti-CD38 antibody. This submission provides further details on the Chemistry,
Manufacturing and Controls (CMC) module to address the outstanding regulatory
requests from the FDA in May 2020 following the original BLA submission in March
2020.
The full text of bluebird's press release regarding the announcement 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
Exhibit
No. Description
99.1 Press release issued by bluebird bio, Inc. on July 2 9 , 2020.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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