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OFFON

PFIZER, INC.

(PFE)
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Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency

09/24/2021 | 04:24pm EDT

Pfizer Inc. and OPKO Health Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD) in pediatric patients. The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer’s submission of additional data to the original BLA. In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.


© S&P Capital IQ 2021
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Analyst Recommendations on PFIZER, INC.
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Financials (USD)
Sales 2021 81 557 M - -
Net income 2021 18 627 M - -
Net Debt 2021 29 307 M - -
P/E ratio 2021 12,6x
Yield 2021 3,68%
Capitalization 240 B 240 B -
EV / Sales 2021 3,31x
EV / Sales 2022 3,77x
Nbr of Employees 78 500
Free-Float 59,3%
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Technical analysis trends PFIZER, INC.
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Income Statement Evolution
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Mean consensus OUTPERFORM
Number of Analysts 20
Last Close Price 42,86 $
Average target price 45,72 $
Spread / Average Target 6,68%
EPS Revisions
Managers and Directors
Albert Bourla Chairman, Chief Executive & Operating Officer
Frank A. D'Amelio Chief Financial Officer & EVP-Global Supply
Mikael Dolsten Chief Scientific Officer & Research President
Lidia L. Fonseca Executive VP, Chief Digital & Technology Officer
Aida Habtezion Chief Medical Officer
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