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BRISTOL-MYERS SQUIBB COMPANY

(BMY)
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Bristol Myers Squibb Announces FDA Accepts for Priority Review Biologics License Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma

09/20/2021 | 06:59am EDT

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021 and were selected for the official ASCO press program. The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.


ę S&P Capital IQ 2021
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Financials (USD)
Sales 2021 46 353 M - -
Net income 2021 6 492 M - -
Net Debt 2021 28 452 M - -
P/E ratio 2021 20,2x
Yield 2021 3,37%
Capitalization 130 B 130 B -
EV / Sales 2021 3,41x
EV / Sales 2022 3,08x
Nbr of Employees 30 250
Free-Float 76,0%
Chart BRISTOL-MYERS SQUIBB COMPANY
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Bristol-Myers Squibb Company Technical Analysis Chart | BMY | US1101221083 | MarketScreener
Technical analysis trends BRISTOL-MYERS SQUIBB COMPANY
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Mean consensus BUY
Number of Analysts 20
Last Close Price 58,36 $
Average target price 74,73 $
Spread / Average Target 28,0%
EPS Revisions
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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