Merck
- Merck stock surged 10% Friday after it said its investigational pill cuts the risk of hospitalization and death in COVID-19 patients.
- The company will file for emergency-use approval of molnupiravir from the Food and Drug Administration.
- Merck is already making molnupiravir and expects to produce 10 million treatments this year.
- See more stories on Insider's business page.
Merck stock surged Friday after the drug maker said an experimental pill it codeveloped significantly cuts the risk of hospitalization and death in COVID-19 patients.
The company said it will seek emergency-use approval for its pill, called molnupiravir, from the US Food and Drug Administration.
Shares climbed 10% to $82.87 soon after trading began. Merck stock had lost nearly 4% through the end of the third quarter ended Thursday. Meanwhile, shares of COVID vaccine makers Pfizer and Moderna fell 2.5% and 10%, respectively.
The pill reduced the risk of hospitalization or death by about 50%, Merck and its partner, Ridgeback Biotherapeutics, said in a statement Friday.
The emergency-use application will come "as soon as possible," the companies said. An independent data monitoring committee, in consultation with the FDA, recommended they stop recruiting for their late-phase trial of the pill based on results of an interim analysis.
Interim analysis of a phase 3 study of molnupiravir showed 7.3% of patients infected with coronavirus who received the pill were hospitalized through day 29, compared with 14.1% of patients treated with a placebo who were hospitalized or died.
The companies said through day 29 that no deaths were reported in patients who received molnupiravir compared with eight deaths in patients who received a placebo.
Merck said it's been producing molnupiravir in anticipation of results from the MOVe-OUT trial, projecting it will make 10 million treatment courses by the end of this year and more courses in 2022. The pharma heavyweight earlier this year reached a procurement deal with the US government to supply it with about 1.7 million courses of molnupiravir upon securing regulatory clearance.
"This is a phenomenal result. This is a profound game-changer to have an oral pill that had this kind of effect, this magnitude of effect in patients who are at high-risk who are already symptomatic," former FDA Commissioner Scott Gottlieb said Friday on CNBC about results of the interim analysis.
Merck said it plans to submit marketing applications for molnupiravir to other regulatory bodies worldwide.