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BRISTOL-MYERS SQUIBB COMPANY

(BMY)
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Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo with Chemotherapy for Patients with HER2-Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS 5

09/17/2021 | 06:59am EDT

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) = 5. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The positive opinion is based on results from the pivotal Phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) was compared to treatment with chemotherapy alone. Results showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic GC, GEJ cancer or EAC whose tumors express PD-L1 with a combined positive score (CPS) = 5 (the primary endpoints of the study). The statistically significant OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS = 1 and in the all-randomized population. The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments. Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy is approved in the United States for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.


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Financials (USD)
Sales 2021 46 329 M - -
Net income 2021 6 492 M - -
Net Debt 2021 28 443 M - -
P/E ratio 2021 20,1x
Yield 2021 3,40%
Capitalization 128 B 128 B -
EV / Sales 2021 3,39x
EV / Sales 2022 3,06x
Nbr of Employees 30 250
Free-Float 76,0%
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Number of Analysts 20
Last Close Price 57,81 $
Average target price 74,62 $
Spread / Average Target 29,1%
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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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