REGENERON PHARMACEUTICALS, INC.

(REGN)
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U.S. FDA limits use of Regeneron, Lilly COVID-19 antibody treatments

01/24/2022 | 05:33pm EDT

Jan 24 (Reuters) - The U.S. health regulator revised on Monday the emergency use authorizations for COVID-19 antibody treatments from Regeneron and Eli Lilly to limit their use, as the drugs are unlikely to work against the Omicron coronavirus variant.

The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any U.S. states or territories, but may be authorized in certain regions if they work against potential new variants.

The agency highlighted other therapies that are expected to be effective against Omicron, including a rival antibody drug from GlaxoSmithKline and Vir Biotechnology as well as recently authorized antiviral pills from Pfizer and Merck & Co. (https://reut.rs/3FVKVHS)

Last month, the U.S. government had paused the distribution of Regeneron and Lilly's treatments and said the halt would continue until new data emerges on their efficacy against Omicron.

The highly contagious new variant was estimated to account for more than 99% of cases in the United States, as of Jan. 15.

GSK and Vir Biotech are boosting production of their drug, sotrovimab, to help meet soaring demand in the United States. The FDA has also expanded its approval for the use of Gilead Sciences' antiviral COVID-19 drug remdesivir to treat non-hospitalized patients aged 12 years and above.

The Washington Post earlier in the day reported that the FDA was expected to revise authorizations for Regeneron and Lilly's treatments. Regeneron said it is working with the FDA to bring additional monoclonal antibody treatments to patients.

"Pending regulatory discussions, new therapeutic candidates could enter the clinic in coming months," the company said in a statement.

Lilly had no immediate comment but pointed to its statement from December saying its antibody candidate, bebtelovimab, maintains neutralization activity against all known variants of concern, including Omicron.

(Reporting by Amruta Khandekar and Ann Maria Shibu; Editing by Devika Syamnath and Sherry Jacob-Phillips)


ę Reuters 2022
Stocks mentioned in the article
ChangeLast1st jan.
GILEAD SCIENCES, INC. 0.38% 63.93 Delayed Quote.-12.33%
GLAXOSMITHKLINE PLC 0.00% 1782 Delayed Quote.10.92%
PFIZER, INC. 0.51% 53.165 Delayed Quote.-10.45%
REGENERON PHARMACEUTICALS, INC. -0.05% 681.54 Delayed Quote.7.98%
VIR BIOTECHNOLOGY, INC. -7.17% 22.41 Delayed Quote.-42.35%
All news about REGENERON PHARMACEUTICALS, INC.
05/23SVB Securities Initiates Regeneron Pharmaceuticals at Outperform with $738 Price Target
MT
05/23Fda approves dupixent (dupilumab) as first treatment for adults and children aged 12 an..
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05/23Evkeeza (evinacumab) phase 3 trial demonstrates 48% ldl-c reduction in children with ul..
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05/23FDA approves Dupixent« (dupilumab) as first treatment for adults and children aged 12 ..
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05/23SVB Securities Initiates Regeneron Pharmaceuticals at Outperform With $738 Price Target
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05/23Regeneron's Phase 3 Trial Data Shows Positive Results for Potential Treatment of Rare H..
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05/21Evkeeza« (evinacumab) Phase 3 Trial Demonstrates 48% LDL-C Reduction in Children with U..
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05/20Regeneron, Sanofi Receive US FDA Approval of Dupixent for Eosinophilic Esophagitis
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05/20Sanofi's Dupixent wins U.S. approval for bigger use
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05/20FDA Grants Regeneron Approval for Dupixent in Inflammatory Disorder Treatment
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Financials (USD)
Sales 2022 11 835 M - -
Net income 2022 4 041 M - -
Net cash 2022 8 670 M - -
P/E ratio 2022 18,4x
Yield 2022 -
Capitalization 73 473 M 73 473 M -
EV / Sales 2022 5,48x
EV / Sales 2023 4,84x
Nbr of Employees 10 492
Free-Float 81,0%
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Mean consensus OUTPERFORM
Number of Analysts 23
Last Close Price 681,91 $
Average target price 691,67 $
Spread / Average Target 1,43%
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Managers and Directors
Leonard S. Schleifer Chairman, Co-President & CEO
George Damis Yancopoulos Co-President, Director & Chief Scientific Officer
Robert E. Landry Chief Financial Officer & Executive VP-Finance
P. Roy Vagelos Chairman
Neil Stahl SVP-Preclinical Development
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