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REGEN-COV™ (casirivimab and imdevimab) Phase 3 RECOVERY Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking an Immune Response to SARS-CoV-2
6/16/2021
Regeneron Pharmaceuticals, Inc. welcomed positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19.
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Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19
4/12/2021
Second Phase 3 trial undertaken in collaboration with NIAID to announce results , both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection
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Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients
3/23/2021
Companion dose-ranging Phase 2 trial showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg
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EMA Issues Advice on Regeneron's Antibody Cocktail (casirivimab with imdevimab) for Certain COVID-19 Patients
2/26/2021
EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail;
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Regeneron Reports Positive Interim Data with REGEN-COV™ Antibody Cocktail used as Passive Vaccine to Prevent COVID-19
1/26/2021
Regeneron Pharmaceuticals, Inc.. (NASDAQ: REGN) today announced positive initial results from an ongoing Phase 3 clinical
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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses
1/12/2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals
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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen
12/29/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen.
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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19
12/17/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19.
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Regeneron's REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization
11/22/2020
Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program
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The decision to halt critically ill patients was made in response to Regeneron’s independent safety board finding a potential safety signal and an unfavorable risk-benefit profile of the monoclonal antibody therapy in a subgroup of patients requiring high-flow oxygen or mechanical ventilation.
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The positive findings were shared as part of the company’s Emergency Use Authorization submission for its investigational COVID-19 therapy.
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Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention
10/28/2020
Today's data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits Regeneron has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 lo
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Although still preliminary, Regeneron Pharmaceuticals announced early data from its Phase I/II/III trial of its antibody cocktail, REGN-COV2, against COVID-19.
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Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients
9/29/2020
Greatest improvements in patients who had not mounted their own effective immune response prior to treatment Plan rapidly to discuss results with regulatory authorities Regeneron to host investor and media webcast to discuss results at 4:30 pm ET today Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today a
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Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinical trial of LY-COV555, its neutralizing antibody therapy for COVID-19.