FDA Turns Away Bristol-Myers, Bluebird Ide-Cel Application
May 13 2020 - 7:58AM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. and Bluebird bio Inc. on Wednesday said
the U.S. Food and Drug Administration has turned away their
biologics license application for idecabtagene vicleucel because
the agency requires more information.
The companies said the FDA determined the chemistry,
manufacturing and control module of the application requires
further detail to complete the review, and they noted the agency
isn't requiring any additional clinical or non-clinical data.
New York-based Bristol-Myers said it plans to resubmit the
application by the end of July.
Bristol-Myers and Bluebird are seeking approval of idecabtagene
vicleucel, or ide-cel, for patients with heavily pre-treated
relapsed and refractory multiple myeloma. Ide-cel is one of three
for drugs tied to the contingent value rights Bristol-Myers issued
to Celgene shareholders as part of its $74 billion takeover and
must gain FDA approval by the end of March 2021 to trigger payment
under the CVRs.
Shares of Bluebird, a Cambridge, Mass., clinical-stage
biotechnology company, fell 8.6% in premarket trading Wednesday.
Bristol-Myers shares were roughly flat.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 13, 2020 07:43 ET (11:43 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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