Regeneron Prescribed drugs, Inc. REGN introduced th
Regeneron Prescribed drugs, Inc. REGN introduced that its section III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 sufferers was profitable.
The research evaluated the corporate’s investigational cocktail antibody, REGEN-COV, in contaminated non-hospitalized sufferers (n=4,567).
The research met its major endpoint, exhibiting that the investigational REGEN-COV considerably decreased the danger of hospitalization or demise by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) in comparison with placebo. REGEN-COV additionally met all secondary endpoints within the section III outcomes trial, together with the power to scale back symptom length.
Individually, a companion dose-ranging section II research of 803 outpatient COVID-19 sufferers was performed to judge the antiviral impact of a number of totally different REGEN-COV doses (IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600 mg). All examined doses met the first endpoint, quickly and considerably lowering sufferers’ viral load. Every dose demonstrated related efficacy, together with the bottom doses examined (IV: 300 mg; SC: 600 mg).
Based mostly on these encouraging information, Regeneron will share new information with regulatory authorities instantly and request {that a} decrease 1,200 mg dose be added to the Emergency Use Authorization.
These section III information may even kind the premise for a full Biologics License Software.
We remind buyers that REGEN-COV obtained an EUA from the FDA in November 2020 for the therapy of mild-to-moderate COVID-19 in adults in addition to pediatric sufferers at the least 12 years of age and weighing at the least 40 kg, who’ve obtained constructive outcomes of direct SARS-CoV-2 viral testing and are at excessive danger for progressing to extreme COVID-19 and/or hospitalization.
Regeneron’s shares have gained 3.8% previously 12 months in contrast with the trade’s development of 18.5%.
Knowledge revealed earlier additionally confirmed that the REGEN-COV antibody cocktail is efficient in opposition to the SARS-CoV-2 variants.
Regeneron has a collaboration settlement with Roche RHHBY for REGEN-COV exterior the US.
Given the alarming ranges of the unfold and severity of the pandemic, fairly a couple of pharma/biotechs are growing antibodies or evaluating their accredited medicine or pipeline candidates to find out if they’re efficient sufficient to deal with the contaminated sufferers. The rising new strains pose a larger menace.
Earlier, Vir Biotechnology, Inc. VIR and associate GlaxoSmithKline plc GSK introduced that an Unbiased Knowledge Monitoring Committee (IDMC) has really useful that its late-stage research evaluating VIR-7831 (GSK4182136) as monotherapy for the early therapy of COVID-19 in adults at excessive danger of hospitalization ought to pause enrollment attributable to proof of profound efficacy.
Regeneron at the moment carries a Zacks Rank #3 (Maintain). You possibly can see the entire record of as we speak’s Zacks #1 Rank (Robust Purchase) shares right here.
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