Merck & Co Stock Price, News & Analysis

Merck has received European Commission approval for KEYTRUDA as the first anti-PD-1 immunotherapy for adjuvant treatment in patients aged 12 and older with stage IIB and IIC melanoma post-complete resection. This decision follows positive outcomes from the Phase 3 KEYNOTE-716 trial, where KEYTRUDA significantly reduced the risk of recurrence by 39% and distant metastasis by 36%. The treatment underscores Merck's commitment to advancing melanoma therapies, addressing a significant public health issue that claimed over 26,000 lives in Europe in 2020.

VAXNEUVANCE has been recommended by the CDC's ACIP as a vaccination option for infants and children, marking the first new pediatric pneumococcal conjugate vaccine in nearly a decade. This 15-valent vaccine can be used in place of the existing 13-valent vaccine for children under 19 years. The recommendation aims to combat serious diseases in children under 5, highlighting its relevance as serotypes 22F and 33F are increasingly responsible for invasive diseases. The final recommendation will be formalized in the CDC's MMWR.

The FDA has approved an expanded indication for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine by Merck (NYSE: MRK), for use in children aged 6 weeks to 17 years. Clinical trials showed VAXNEUVANCE elicited non-inferior immune responses to PCV13 for shared serotypes and superior responses for serotype 3 and unique serotypes 22F and 33F. This marks the first approval of a pediatric pneumococcal conjugate vaccine in nearly a decade, addressing serious health risks from invasive pneumococcal disease, particularly in children under 5.

Merck (NYSE: MRK) and AstraZeneca announced promising results from the Phase 3 PROpel trial, published in NEJM Evidence, showcasing LYNPARZA combined with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients. The trial results indicated a 34% reduction in disease progression risk, with median rPFS at 24.8 months for the combination therapy, compared to 16.6 months for standard treatment. This data could lead to new first-line treatment options for mCRPC.

Merck (MRK) announced the appointment of Chirfi Guindo as the Chief Marketing Officer for Human Health, effective July 1, 2022. Guindo will oversee marketing strategies across various areas, including oncology and vaccines, reporting directly to CEO Robert M. Davis. Guindo brings extensive experience, having previously held senior roles at Biogen and within Merck itself, focusing on product strategy and commercialization. This leadership change is expected to enhance Merck's Human Health portfolio and address significant medical challenges globally.

Merck (NYSE: MRK) announced positive results from the Phase 1/2 study of V116, a 21-valent pneumococcal conjugate vaccine. The study demonstrated V116's safety and immunogenicity in adults aged 18-49 and 50 and older, meeting primary immunogenicity objectives. In Phase 2, V116 showed non-inferior responses to PNEUMOVAX 23 for shared serotypes and superior responses for unique serotypes. V116 targets serotypes responsible for 85% of invasive pneumococcal disease in adults 65 and older. It received Breakthrough Therapy Designation from the FDA for preventing invasive pneumococcal disease.

Merck (NYSE: MRK) announced that the FDA has accepted for review a supplemental Biologics License Application for KEYTRUDA as an adjuvant treatment for stage IB (≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC) after surgical resection. This application is based on the Phase 3 KEYNOTE-091 trial, which showed improved disease-free survival (DFS) for patients. The FDA’s target action date is January 29, 2023. If approved, KEYTRUDA would be the first adjuvant immunotherapy option for these NSCLC stages post-surgery, expanding Merck's oncology portfolio.

Merck (NYSE: MRK) will participate in the 2022 Goldman Sachs 43rd Annual Global Healthcare Conference on June 13, 2022, at 3:20pm PT / 6:20pm ET. CEO Robert M. Davis and Dean Y. Li, President of Merck Research Laboratories, will engage in a fireside chat. The event invites investors, analysts, and the public to listen live at this link. Merck continues to leverage scientific advancements to enhance health solutions globally, emphasizing innovation and responsibility.

Merck and Ridgeback Biotherapeutics report new data from the Phase 3 MOVe-OUT trial for LAGEVRIO (molnupiravir), an oral antiviral for high-risk COVID-19 patients. Key findings show a 32.1% reduction in acute care visits in LAGEVRIO patients versus placebo. The need for respiratory interventions was 34.3% lower in LAGEVRIO-treated participants. Those hospitalized after randomization had a median discharge time of 9 days vs. 12 days for placebo. LAGEVRIO has demonstrated significant efficacy in reducing severe COVID-19 progression.