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MarketScreener Homepage  >  Equities  >  Nyse  >  Bristol-Myers Squibb Company    BMY

BRISTOL-MYERS SQUIBB COMPANY

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Bristol Myers, Bluebird Get FDA Priority Review for Ide-cel

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09/22/2020 | 08:40am EDT

By Colin Kellaher

 

Bristol Myers Squibb Co. and bluebird bio Inc. on Tuesday said the U.S. Food and Drug Administration granted priority review to their biologics license application for idecabtagene vicleucel, or ide-cel, for the treatment of adults with the blood cancer multiple myeloma.

The companies are seeking approval of the CAR T cell immunotherapy for patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Bristol Myers and bluebird said the agency set a target action date of March 27 for the application.

Ide-cel is one of three 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.

The FDA in May turned away the companies' initial application for ide-cel with a request for more information. New York-based Bristol Myers and bluebird, a Cambridge, Mass., clinical-stage biotechnology company, resubmitted the application in late July.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 


Stocks mentioned in the article
ChangeLast1st jan.
BLUEBIRD BIO, INC. 0.22% 53.72 Delayed Quote.-39.01%
BRISTOL-MYERS SQUIBB COMPANY -1.57% 58.695 Delayed Quote.-7.04%
IDE GROUP HOLDINGS PLC 0.00% 1.125 Delayed Quote.-74.43%
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Financials (USD)
Sales 2020 42 043 M - -
Net income 2020 1 488 M - -
Net Debt 2020 31 283 M - -
P/E ratio 2020 237x
Yield 2020 2,99%
Capitalization 134 B 134 B -
EV / Sales 2020 3,94x
EV / Sales 2021 3,48x
Nbr of Employees 30 000
Free-Float 77,0%
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Mean consensus BUY
Number of Analysts 19
Average target price 73,56 $
Last Close Price 59,67 $
Spread / Highest target 47,5%
Spread / Average Target 23,3%
Spread / Lowest Target 7,26%
EPS Revisions
Managers
NameTitle
Giovanni Caforio Chairman & Chief Executive Officer
David V. Elkins Chief Financial Officer & Executive Vice President
Paul von Autenried Chief Information Officer & Senior Vice President
Vicki L. Sato Lead Independent Director
Gerald L. Storch Independent Director
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