Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) and Ridgeback Biotherapeutics received a positive vote from the FDA's Antimicrobial Drugs Advisory Committee, recommending Emergency Use Authorization (EUA) for molnupiravir (MK-4482), an oral antiviral for treating mild to moderate COVID-19 in high-risk adults. The committee voted 13-10, asserting the benefits outweigh risks. Data from the MOVe-OUT study showed molnupiravir reduced hospitalization or death by approximately 50%. Merck is gearing up for production and aims for broad access to molnupiravir globally.

Merck (NYSE: MRK) has declared a quarterly dividend of $0.69 per share for Q1 2022, with payment set for Jan. 7, 2022. Shareholders on record by Dec. 15, 2021 will receive the dividend. This move reflects Merck's commitment to returning value to shareholders while highlighting its ongoing initiatives in healthcare.

Merck's KEYTRUDA has been approved by Japan's PMDA as a first-line treatment for advanced esophageal cancer in combination with chemotherapy (5-FU and cisplatin). This marks KEYTRUDA's 16th indication in Japan. The approval is based on the Phase 3 KEYNOTE-590 trial, which showed a 27% reduction in death risk and a 35% reduction in disease progression compared to standard chemotherapy. Esophageal cancer poses a significant health burden in Japan, with over 26,000 new cases annually. Merck continues to expand KEYTRUDA's applications in various gastrointestinal cancers.

Merck (NYSE: MRK) and AstraZeneca announced the acceptance of a supplemental New Drug Application for LYNPARZA, targeting BRCA mutations in early-stage HER2-negative breast cancer. The FDA granted priority review, with a target action date in Q1 2022. The application was based on the Phase 3 OlympiA trial, showing a 42% reduction in the risk of invasive breast cancer recurrence. LYNPARZA is already approved for several cancer indications, and its safety profile aligns with previous trials, with common adverse events including nausea and fatigue.

Merck (NYSE: MRK) and Eisai announced the European Commission's approval of KEYTRUDA and LENVIMA for treating advanced or recurrent endometrial carcinoma in adults. This is the first combination of an immunotherapy with a tyrosine kinase inhibitor approved in Europe for patients who have seen disease progression after platinum-based therapies and are not surgical candidates.

The decision is based on the pivotal Phase 3 KEYNOTE-775/Study 309, showing a 38% reduction in death risk and a 44% reduction in disease progression risk compared to chemotherapy.

Merck (NYSE: MRK) and Eisai announced that the European Commission has approved the combination therapy of KEYTRUDA and LENVIMA for treating advanced renal cell carcinoma (RCC). This decision follows results from the CLEAR/KEYNOTE-581 trial, showing that this combination reduced the risk of disease progression or death by 61% compared to sunitinib, with a median progression-free survival of 23.9 months. The combination also showed an overall survival benefit and a higher objective response rate, providing new hope for advanced RCC patients in Europe.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics have released data from the MOVe-OUT study of molnupiravir, an oral antiviral for COVID-19. The study, involving 1,433 participants, showed a reduction in hospitalization or death rates from 9.7% in the placebo group to 6.8% in the treatment group, achieving a 30% relative risk reduction. The FDA is reviewing Merck's Emergency Use Authorization application, with discussions scheduled for Nov. 30. Previously, an interim analysis had indicated even greater efficacy, reducing risks by 48%.

Merck (NYSE: MRK) will have Frank Clyburn, EVP and Human Health President, participate in the 4th Annual Evercore ISI HealthCONx Conference. The virtual event is set for December 1, 2021, at 10:30 a.m. ET. Investors, analysts, and the general public can access a live webcast of the presentations at Merck's investor relations website. Merck, a leading biopharmaceutical company with a legacy of over 130 years, focuses on developing innovative medicines and vaccines to enhance health outcomes globally.

Organon (NYSE: OGN) announced that CEO Kevin Ali and CFO Matthew Walsh will participate in a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on December 1, 2021, at 1:50 p.m. ET. Investors, analysts, and the public can access a live video webcast at this link. Organon focuses on women's health and has over 60 products across various therapeutic areas, serving over 140 markets globally and employing approximately 9,000 people.