Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) has signed a procurement agreement with the U.S. government for molnupiravir (MK-4482), an investigational COVID-19 therapy currently in Phase 3 trials. If authorized, Merck will provide approximately 1.7 million treatment courses for around $1.2 billion. The company aims to have over 10 million courses available by the end of 2021. Merck is also pursuing global availability through tiered pricing and licensing agreements in 104 low- and middle-income countries. The ongoing MOVe-OUT study may lead to an Emergency Use Authorization later in 2021.

Merck (MRK) and Eisai have shared new findings from the pivotal Phase 3 CLEAR/KEYNOTE-581 trial, evaluating KEYTRUDA combined with LENVIMA for advanced renal cell carcinoma (RCC). This analysis, presented at ASCO 2021, indicates improved health-related quality of life (HRQoL) for patients using KEYTRUDA and LENVIMA over sunitinib. Key results showed better scores in physical functioning and fatigue at a mean follow-up of 46 weeks. The findings support the combination as a potential first-line treatment option, with data currently under FDA review.

Merck announced pivotal Phase 3 KEYNOTE-564 trial results for KEYTRUDA, demonstrating a 32% reduction in disease recurrence or death risk in renal cell carcinoma (RCC) patients post-nephrectomy. The trial involved 994 patients, showing KEYTRUDA's two-year disease-free survival rate at 77.3% versus 68.1% for placebo. Adverse events were noted, with 18.9% experiencing grade 3-5 treatment-related issues. As the first immunotherapy illustrating clinical benefit in RCC adjuvant treatment, KEYTRUDA could set new care standards. Outcomes will be presented at the 2021 ASCO Annual Meeting.

AstraZeneca and Merck (NYSE: MRK) announced significant findings from the Phase 3 OlympiA trial for LYNPARZA, which showed a 42% reduction in the risk of invasive breast cancer recurrence in patients with germline BRCA1/2 mutations compared to placebo. The data, presented at the 2021 ASCO Annual Meeting and published in the New England Journal of Medicine, highlighted a 3-year iDFS rate of 85.9% for LYNPARZA versus 77.1% for placebo. Secondary results also indicated a 43% reduction in distant disease-free survival risk. The trial continues to assess overall survival.

Merck (NYSE: MRK) has successfully completed the spinoff of Organon & Co., creating an independent publicly traded company. This strategic move aims to enhance each entity's operational focus and financial profiles. Merck anticipates achieving approximately $1.5 billion in operating efficiencies over three years, with an estimated $500 million realized in 2021. The spinoff involved a $9 billion distribution from Organon to Merck shareholders. Organon will now trade under the symbol 'OGN' on the New York Stock Exchange, while Merck retains 'MRK'.

Merck's first hexavalent vaccine, VAXELIS, is now available in the U.S. This combination vaccine protects against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive Haemophilus influenzae type b disease. VAXELIS is approved for a 3-dose series for children aged 6 weeks to 4 years.

It aims to reduce the number of shots required in early childhood vaccinations. The CDC includes it in the recommended immunization schedule, and it will be distributed via public and private channels. Safety information details contraindications and potential side effects.

Sanofi and Merck have announced that Vaxelis, the first hexavalent combination vaccine in the U.S., is now available. This vaccine protects against six diseases: diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B, administered in three doses to children aged 6 weeks to 4 years. The vaccine aims to reduce the number of shots children need, improving vaccination coverage. Vaxelis has been included in the CDC's immunization schedule and will be distributed through various channels. The collaboration reflects a commitment to enhancing pediatric health.

Merck (NYSE: MRK) has announced a quarterly dividend of $0.65 per share for the third quarter of 2021. The payment will be made on July 7, 2021 to shareholders recorded by the end of business on June 15, 2021. This announcement underscores Merck's ongoing commitment to returning value to its shareholders while continuing its mission to innovate in healthcare.

Merck (NYSE: MRK) announced that the European Medicines Agency's CHMP has recommended approving KEYTRUDA for first-line treatment in adults with locally advanced or metastatic esophageal carcinoma and HER2-negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1. This positive opinion is based on the Phase 3 KEYNOTE-590 trial, showing KEYTRUDA significantly improves overall and progression-free survival. A final decision from the European Commission is expected in Q2 2021, highlighting the urgent need for new treatment options in this patient population.