GlaxoSmithKline & Vir Biotechnology’s Sotrovimab Antibody Cleared for Emergency Use in the U.S.


GlaxoSmithKline (GSK) and Vir Biotechnology’s (VIR) investigational single-dose monoclonal antibody sotrovimab (previously named VIR-7831) has been authorized for emergency use by the U.S. Food and Drug Administration (FDA). Shares of Vir’s biotech firm have jumped more than 9% in Thursday’s pre-market trading.

The antibody has been designed for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older who have a minimum weight of 40 kg. Furthermore, individuals with positive results of direct SARS-CoV-2 viral testing and are at high risk for progression to severe COVID-19 including hospitalization or death, come under the purview of this treatment.

The data released from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial reflected that sotrovimab has a favorable tolerability profile. GSK and Vir Biotechnology are planning to make sotrovimab available to patients in the U.S. in the coming weeks. Notably, the companies are also in talks with global government agencies to make this antibody available to patients in need of treatment.

Vir Biotechnology CEO George Scangos said, “Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85% reduction in all-cause hospitalizations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India. I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well. At Vir, our aim is not only to deliver a clinically effective therapy for COVID-19, but also to provide effective therapy against SARS-CoV-2 variants and potential pandemics of tomorrow.” (See Vir stock analysis on TipRanks)

On May 20, H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating and a price target of $135 (195% upside potential).

Trucchio said, “The IM formulation could dramatically widen the availability of VIR-7831 and put Vir and its collaboration partner GlaxoSmithKline at a strategic advantage as compared to other antiviral companies in the COVID-19 space. VIR shares have pulled back since February, in part, we think, owing to high vaccination rates in the U.S. and EU; however, we continue to view SARS-CoV-2 as becoming endemic in the human population, and with new variants emerging, and with incomplete vaccination coverage in developed markets along with continued spread in developing markets, a robust global market for COVID-19 antivirals is likely to develop.”

The consensus rating among analysts is a Strong Buy based on 4 unanimous Buys. The average analyst price target stands at $94.25 and implies upside potential of 106% to current levels over the next 12 months. Shares have gained 42.1% over the past year.

Furthermore, TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Vir Biotechnology, with 7% of investors increasing their exposure to VIR stock over the past 30 days.

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