Vir Biotechnology Inc (NASDAQ: VIR) shares jumped roughly 10% in after-hours trading on Wednesday as the company received emergency use authorisation for its COVID-19 drug from the U.S Food and Drug Administration (FDA).
The federal agency’s approval for Sotrovimab (VIR-7831) that the biotech firm developed in collaboration with GlaxoSmithKline applies to pediatric patients and high-risk adults for the treatment of mild-to-moderate COVID-19. GSK also worked with Sanofi to develop a different COVID-19 vaccine.
Are you looking for fast-news, hot-tips and market analysis?
Sign-up for the Invezz newsletter, today.
According to the health regulator, the monoclonal antibody drug is not to be used in patients that require oxygen therapy or are otherwise hospitalised due to COVID-19.
Sotrovimab will be available in coming weeks
In a joint statement, the two companies expressed confidence that Sotrovimab will be available as a treatment for the Coronavirus disease in the coming weeks. Marketing application for the drug, they added, will be submitted to FDA in H2 of 2021.
Regeneron Pharmaceuticals also secured emergency use authorisation for its similar COVID-19 therapy from the U.S. FDA late last year. The EU’s drug regulator endorsed Sotrovimab as a COVID-19 treatment last week for high-risk patients that do not require supplemental oxygen.
CEO George Scangos’ remarks
Commenting on the news, CEO George Scangos of Vir Biotech 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 hospitalisations 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.”
Vir Biotech’s performance in the stock market
Vir Biotechnology lost last night’s gain before market open on Thursday. The stock is currently exchanging hands at $43.49 per share (£30.67 per share) versus a year-to-date high of $83.07 per share in the last week of January. In comparison, Vir had started the year at a per-share price of a much lower $26.75.
Vir Biotechnology performed massively upbeat in the stock market last year with an annual gain of close to 120%. At the time of writing, the San Francisco-based company has a market capitalisation of $5.69 billion.