Merck Gives Up Gains Ahead of FDA Review of Covid-19 Pill

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Investing.com – Merck stock (NYSE:MRK) traded 3.5% lower in Friday’s premarket while the company awaits details of FDA’s review of the Covid-19 pill it has jointly developed with Ridgeback Biotherapeutics.

The stock traded 1.2% higher initially but was weighed down by broader market concerns over the emergence of a new variant of the coronavirus in South Africa. 

The companies claim that the antiviral pill, molnupiravir, reduces the risk of hospitalization or death in patients suffering from the currently dominant strain of Covid-19.  There is no evidence to indicate whether or not the drug, molnupravir, would be effective against the new strain.

The report from Food and Drug Administration staff, expected Friday, will cover an analysis of clinical-trial data for molnupiravir. The report may also include FDA staff’s view on whether the agency should clear the drug for use.

If approved, molnupiravir could be the world’s first oral antiviral medicine for Covid.

The company had earlier said that if the emergency use approval comes through in December, the drug offers an opportunity of up to $7 billion in sales in 2022 including $1 billion in revenue this year.

The drug is relatively cheap to make and easy to transport. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses in 2022. It has agreed to supply 3.1 million courses to the U.S. government, assuming all necessary approvals are given.

Merck’s antiviral pill is one of only three oral medicines so far to prove their efficacy against Covid-19, along with treatments from Pfizer (NYSE:PFE) and Regeneron (NASDAQ:REGN). Pfizer claims to reduce the risk of hospitalization or death by 89%.