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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck announces significant advancements in gender diversity within its small molecule process research & development (SM PR&D) team, with the representation of women nearly doubling over the past seven years. Jamie McCabe Dunn, Director of Process Chemistry, emphasizes that diversity and inclusion drive innovation. Initiatives include active recruitment by women leaders and partnerships with academic institutions. Recognizing the contributions of female scientists, 12 women from the department have received prestigious awards in the last three years. The company asserts its commitment to fostering a more equitable environment for future generations.
Merck (NYSE: MRK) announced that its Phase 3 NRG-GY018 trial of KEYTRUDA, in combination with chemotherapy, significantly improved progression-free survival (PFS) in patients with stage III-IV or recurrent endometrial carcinoma. This trial met its primary endpoint, showing meaningful results for both mismatch repair proficient (pMMR) and deficient (dMMR) patients. The safety profile was consistent with previous studies, with no new safety signals. These findings will be presented at an upcoming medical meeting. KEYTRUDA's promising results highlight its potential as a treatment option for advanced endometrial cancer, which often has limited options.
Merck (NYSE: MRK) reported an exceptional financial performance for 2022, with a 22% increase in worldwide sales to $59.3 billion and a 17% rise in GAAP EPS to $5.71. Fourth-quarter sales reached $13.8 billion, marking a 2% year-on-year increase and 8% excluding foreign exchange impacts. KEYTRUDA, Merck's leading oncology drug, saw sales grow by 22% to $20.9 billion. The company's 2023 outlook anticipates sales between $57.2 billion and $58.7 billion and GAAP EPS between $5.86 and $6.01, incorporating an expected $1.0 billion in LAGEVRIO sales.
Merck (NYSE: MRK) announced FDA approval for KEYTRUDA as a single agent for adjuvant treatment in adults with stage IB, II, or IIIA non-small cell lung cancer (NSCLC) after surgical resection and platinum-based chemotherapy. This marks the fifth indication for KEYTRUDA in NSCLC and the 34th overall in the U.S. The approval stems from the KEYNOTE-091 trial, which showed a 27% reduction in disease recurrence or death compared to placebo, with a median disease-free survival of 58.7 months for the KEYTRUDA group versus 34.9 months for placebo. The treatment offers a new option for patients with stage IB disease, regardless of PD-L1 expression.
Merck Animal Health, a division of Merck & Co., Inc. (NYSE:MRK), has received FDA approval for the expanded use of BRAVECTO® Chews for Dogs, now treating and controlling infestations of the Asian longhorned tick. This is the first product in the U.S. addressing this invasive tick species, which poses health risks to pets and humans. The approval enhances BRAVECTO's comprehensive parasite protection portfolio, underscoring Merck's commitment to innovative veterinary solutions. With over 250 million doses distributed since 2014, BRAVECTO aims to offer pets prolonged protection against various parasites.
Merck (NYSE: MRK) has announced the cessation of the Phase 3 KEYNOTE-991 trial for KEYTRUDA, its anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC). This decision follows a recommendation from an independent Data Monitoring Committee after an interim analysis revealed no improvement in overall survival or radiographic progression-free survival compared to the control group. Although no new safety signals were identified, the combination treatment exhibited a higher rate of Grade 3-5 adverse events. Merck remains committed to developing new treatment options for prostate cancer.
Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-966 trial, demonstrating that KEYTRUDA, in combination with chemotherapy, significantly improves overall survival for patients with advanced biliary tract cancer compared to chemotherapy alone. The safety profile was consistent with earlier studies. With biliary tract cancer's poor prognosis, highlighted by only 5% to 15% five-year survival rates, these results offer hope for new treatment options. Merck plans to present results at a medical meeting and submit them to regulatory authorities while continuing to explore KEYTRUDA's use in various gastrointestinal cancers.
Merck (NYSE: MRK) has declared a quarterly dividend of $0.73 per share for Q2 2023. Shareholders of record will receive this payment on April 10, 2023, with the record date being March 15, 2023. Merck aims to leverage leading-edge science to improve lives worldwide, boasting over 130 years in the biopharmaceutical industry. The company emphasizes research and innovation in health solutions for both people and animals, while fostering a diverse and inclusive workforce.
Perceiv AI has been chosen for the inaugural cohort of the Merck Digital Sciences Studio (MDSS), receiving funding and mentorship from Merck (NYSE: MRK), Northpond Ventures, and McKesson Ventures. This selection, announced on January 17, 2023, is a significant milestone for Perceiv AI, highlighting their innovative prognostic platform that integrates multimodal data to address neurodegenerative diseases. The MDSS program aims to enhance drug discovery and development through collaborations and access to advanced technology. Perceiv AI plans to expand its ForesightTM platform to develop biomarkers for conditions like Alzheimer's disease.
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