Merck & Co. (MRK) - Get Free Report shares slumped lower Friday after the drugmaker published data from a large-scale trial of its COVID pill treatment that showed a lower-than-expected efficacy rate against hospitalization and death in high-risk patients.
Merck said the 'molnupiravir' oral treatment, developed with Ridgeback Biotherapeutics, reduced the risk of hospitalization and death in high-risk patients by 30%, well shy of the 48% rate it reported from an earlier trial ending in October, although it noted the adverse event profile remained consistent.
Molnupiravir, or MK-4482, is designed to induce so-called "copying errors" within a harmful virus that prevent it from replicating in the human body.
Merck said the data will be submitted to the U.S. Food & Drug Administration, which is reviewing its application for Emergency Use Authorization of the molnupiravir treatment, on November 30.
based on the pre-specified interim analysis based on data from 762 patients, which is the primary analysis of the study.
"Merck and Ridgeback Biotherapeutics have conducted a rigorous development program for molnupiravir, and believe that molnupiravir has the potential to address a significant unmet medical need for an oral medicine for adults with COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization," the companies said in a statement Friday. "We look forward to working with the FDA and other agencies as they review our applications."
Merck shares were marked 4.9% lower in early trading Friday to change hands at $78.40 each.
Late last month, Merck posted better-than-expected earnings of $1.75 per share for the three months ending in September, with revenues 20% to $12.34 billion thanks in part to strong sales of of Keytruda, its blockbuster cancer treatment, as well as its HPV vaccine Gardasil.
Looking into the 2021 financial year, Merck said it sees worldwide sales of between $47.4 billion to $47.9 billion and non-GAAP earnings of between $5.65 to $5.70 per share, up from its prior forecast of $5.47 to $5.57.