Shares in Regeneron advanced 3.5% in Wednesday’s extended market session after the company filed for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for its REGN-COV2 investigational antibody cocktail for the treatment of Covid-19.
Regeneron (REGN) said that the submission followed discussions with regulatory authorities. The biotech company already has an agreement with the US government for initial doses of REGN-COV2. According to the agreement, provided the EUA is granted, the US government has committed to making these doses available to Americans at no cost and would be responsible for their distribution.
At this point, there are available doses for approximately 50,000 patients.
“We expect to have doses available for 300,000 patients in total within the next few months,” Regeneron said in a statement.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19. Preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates.
Regeneron recently released early clinical data, which showed that non-hospitalized Covid-19 patients treated with REGN-COV2 had reduced viral levels and experienced improved symptoms.
Last week, Regeneron confirmed that US President Donald Trump was given a single 8 gram dose of REGN-COV2. The investigational Covid-19 therapy was provided in response to an Individual Patient Investigational New Drug (IND) application (commonly known as ‘compassionate use’ request) from the President’s physicians.
“I went in, I wasn’t feeling so hot, and within a very short period of time they gave me Regeneron – and other things too, but I think this was the key,” Trump said in a video posted on Twitter. “I felt good immediately.”
Shares in Regeneron have soared 58% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s alongside an average analyst price target of $666.86 indicating upside potential of 13% from current levels.
Canaccord Genuity analyst John Newman yesterday reiterated a Buy rating on the stock with a $700 price target (18.3% upside potential), saying that he expects strong demand for a Covid-19 antibody therapy.
Newman believes that demand will “far outstrip supply for the foreseeable future,” and thus he doesn’t see much competitive risk for Regeneron’s therapy versus other competitors’ candidates such as Eli Lilly’s. (See Regeneron stock analysis on TipRanks).
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