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BRISTOL-MYERS SQUIBB COMPANY

(BMY)
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Bristol Myers Squibb Gets FDA Acceptance of sBLA for Reblozyl

12/03/2021 | 07:31am EST

By Chris Wack

Bristol Myers Squibb said the U.S. Food and Drug Administration has accepted for priority review its supplemental Biologics License Application for Reblozyl luspatercept-aamt for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.

The company said the FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022.

Bristol Myers also said the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co. Inc. following Merck's recent acquisition of Acceleron Pharma Inc.

These applications were based on safety and efficacy results from a Phase 2 study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

12-03-21 0731ET

Stocks mentioned in the article
ChangeLast1st jan.
BRISTOL-MYERS SQUIBB COMPANY 0.51% 64.93 Delayed Quote.4.14%
CORN FUTURES (C) - CBR (FLOOR)/C1 1.49% 596.25 End-of-day quote.0.51%
MERCK & CO., INC. 0.07% 81.38 Delayed Quote.6.18%
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Financials (USD)
Sales 2021 46 408 M - -
Net income 2021 6 271 M - -
Net Debt 2021 28 505 M - -
P/E ratio 2021 22,0x
Yield 2021 3,03%
Capitalization 144 B 144 B -
EV / Sales 2021 3,72x
EV / Sales 2022 3,40x
Nbr of Employees 30 250
Free-Float -
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Mean consensus OUTPERFORM
Number of Analysts 23
Last Close Price 64,93 $
Average target price 71,79 $
Spread / Average Target 10,6%
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Managers and Directors
Giovanni Caforio Chairman & Chief Executive Officer
David V. Elkins Chief Financial Officer & Executive Vice President
Paul von Autenried Chief Information Officer & Executive VP
Rupert J. Vessey Executive VP-Research & Early Development
Joseph E. Eid Senior VP & Head-Global Medical Affairs
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