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REGENERON PHARMACEUTICALS

(REGN)
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Regeneron Gets FDA Priority Review of Libtayo in Advanced Cervical Cancer

09/28/2021 | 05:35am EST

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of the cancer drug Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.

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. Regeneron said the agency set a target action date of Jan. 30, 2022.

Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly developing and commercializing Libtayo under a global collaboration agreement.

Regeneron said the FDA is reviewing the application under its "Project Orbis" initiative, which allows for concurrent review by health authorities in Australia, Brazil, Canada and Switzerland. The company said it also plans to file for European Union approval of the new indication by the end of the year.

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

(END) Dow Jones Newswires

09-28-21 0735ET

Stocks mentioned in the article
ChangeLast1st jan.
REGENERON PHARMACEUTICALS 2.10% 656.4 Delayed Quote.33.17%
SANOFI 0.71% 85.61 Real-time Quote.8.02%
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Financials (USD)
Sales 2021 15 430 M - -
Net income 2021 7 903 M - -
Net cash 2021 5 814 M - -
P/E ratio 2021 9,19x
Yield 2021 -
Capitalization 67 266 M 67 266 M -
EV / Sales 2021 3,98x
EV / Sales 2022 4,46x
Nbr of Employees 9 766
Free-Float 81,9%
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Mean consensus OUTPERFORM
Number of Analysts 24
Last Close Price 643,35 $
Average target price 697,52 $
Spread / Average Target 8,42%
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Managers and Directors
Leonard S. Schleifer Co-President, Chief Executive Officer & Director
George Damis Yancopoulos Co-President, Director & Chief Scientific Officer
Robert E. Landry Chief Financial Officer & Executive VP-Finance
P. Roy Vagelos Chairman
Neil Stahl Executive VP-Research & Development
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