FDA Grants Emergency Use Authorization to Merck’s COVID-19 Treatment

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Merck & Co., Inc. (MRK) and Ridgeback Biotherapeutics’ investigational oral antiviral, molnupiravir, for the treatment of mild to moderate coronavirus disease among adults.

Molnupiravir may not be used for more than five consecutive days; by patients less than 18 years old; to treat patients who have been hospitalized due to COVID-19; or for post- or pre-exposure prophylaxis to prevent COVID-19.

Further, it is not recommended for pregnant women.

Meanwhile, molnupiravir should be administered within five days of the onset of symptoms. The recommended dosage is 800 mg per day, to be taken orally in the form of 200 mg capsules every 12 hours.

The CEO and President of Merck, Robert M. Davis, said, “The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives.”

The EUA was based on the Phase 3 MOVe-OUT trial that studied the antiviral in non-hospitalized adults who had not been vaccinated for COVID-19. Their infection was confirmed by a laboratory and they showed symptoms within five days of study randomization. Further, they suffered from at least one health risk like diabetes or heart disease.

These patients were administered 800 mg of molnupiravir twice a day.

The study found that the medicine reduced the risk of death or hospitalization compared to the patient group that was given a placebo.

Dean Y. Li, President at Merck Research Laboratories, said, “Based on the strong science behind molnupiravir – a single oral medicine that interrupts replication of the SARS-CoV-2 virus, with data demonstrating a significant reduction in the risk of hospitalizations and deaths – molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients.”

Meanwhile, the oral antiviral is also being evaluated in a global Phase 3 study, MOVe-AHEAD, for post-exposure prophylaxis. The study will evaluate the safety and efficacy of molnupiravir in preventing the spread of coronavirus.

About Merck

Headquartered in New Jersey, Merck develops pharmaceutical and vaccine products. It also offers healthcare solutions and vaccines for animal health.

MRK shares closed 0.6% lower on Thursday. However, they gained 0.2% in after-hours trading to end the day at $75.90.

Wall Street’s Take

On December 23, Mizuho Securities analyst Mara Goldstein assigned a Buy rating to the stock with a price target of $100 (32.1% upside potential).

Additionally, last week, Chris Shibutani, an analyst with Goldman Sachs (GS), initiated coverage on Merck with a Hold rating and a $93 price target (22.8% upside potential).

Overall, the stock has a Moderate Buy consensus rating based on 8 Buys and 9 Holds. The average MRK stock forecast of $90.31 implies 19.3% upside potential. Shares have lost nearly 2% year-to-date.

Blogger Opinions

TipRanks data shows that financial bloggers are 94% Bullish on Merck, compared to the sector average of 69%.

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