Merck & Co Stock Price, News & Analysis

The FDA has approved Merck's (NYSE: MRK) KEYTRUDA® (pembrolizumab) in combination with carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status. This marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and its 40th overall in the U.S.

The approval is based on results from the Phase 3 NRG-GY018 trial, which showed significant reductions in disease progression or death by 40% for mismatch repair proficient cancers and 70% for deficient cancers.

However, KEYTRUDA may cause severe or fatal immune-mediated adverse reactions and should be discontinued as necessary. The median progression-free survival for patients with mismatch repair proficient cancers was 11.1 months compared to 8.5 months for the placebo group, while the median was not reached for deficient cancers (30.7 months vs 6.5 months).

Merck has significantly increased the representation of women in its Small Molecule Process Research & Development (SM PR&D) team over the past seven years, nearly doubling the number of female scientists. This growth stems from deliberate efforts to foster diversity and inclusion, seen as key drivers of creativity and innovation.

Key initiatives include women leaders actively recruiting talent, enhancing relationships with academic institutions, and offering career growth opportunities. Notable female scientists at Merck, such as Marguerite Mohan, Niki Patel, and Cindy Hong, have found success and recognition in their roles, contributing to Merck’s reputation as a scientific leader.

Merck's commitment is further highlighted by the 92% success rate in winning external awards for its female scientists. The company continues to focus on diversity, aiming to create a more inclusive environment that supports and retains women in science.

Merck scientists are advancing cancer research by improving anti-tumor immune responses, targeting specific cancer cells, and inhibiting cancer growth. The company is focusing on treating cancers at earlier stages to enhance survival rates, with a robust pipeline addressing over 20 novel mechanisms. Innovations include individualized neoantigen therapies and targeted antibody-drug conjugates. Merck's research includes more than 2,250 ongoing clinical trials, with 1,600 evaluating combination regimens. The goal is to discover new ways to combat cancer and optimize existing treatments.

Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that its CEO Robert M. Davis and EVP Dr. Dean Y. Li will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference. The event is set for Tuesday, June 11, 2024, at 10:00 a.m. EDT. A live audio webcast will be available for investors, analysts, media, and the general public.

Moderna and Merck have reported three-year data from their Phase 2b study showing that the combination of mRNA-4157 (V940) and KEYTRUDA significantly improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 49% and distant metastasis or death by 62% compared to KEYTRUDA alone. The 2.5-year RFS rate for the combination was 74.8% versus 55.6% for KEYTRUDA alone.

The companies have started Phase 3 trials for melanoma and non-small cell lung cancer, and Phase 2 trials for renal and urothelial carcinomas, and a Phase 2/3 trial for cutaneous squamous cell carcinoma. Safety profiles were consistent with previous findings, showing mostly mild to moderate side effects.

Merck (NYSE: MRK) has announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for priority review. The application seeks approval for the use of KEYTRUDA® (pembrolizumab) combined with chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

The acceptance is based on data from the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed a statistically significant improvement in overall survival (OS) when compared to chemotherapy alone. The target action date set by the FDA is September 25, 2024. In the trial, KEYTRUDA combined with chemotherapy reduced the risk of death by 21%, with a median OS of 17.3 months versus 16.1 months for chemotherapy alone. Additionally, the combination treatment showed improvements in progression-free survival (PFS) and objective response rate (ORR).

Merck (NYSE: MRK) has announced its acquisition of EyeBio for an upfront payment of $1.3 billion and up to $1.7 billion in milestone payments, bringing the total potential value to $3 billion. EyeBio's lead candidate, Restoret™, is a late-phase treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is expected to enter pivotal studies in the second half of 2024. The acquisition expands Merck's presence in ophthalmology and aims to leverage EyeBio's expertise in retinal diseases. The transaction, subject to regulatory approval, is anticipated to close in Q3 2024, and Merck expects to record a charge of $1.3 billion upon closing.

Merck (NYSE: MRK), referred to as MSD outside of the US and Canada, has announced a quarterly dividend of $0.77 per share for the third quarter of 2024. The dividend will be paid on July 8, 2024, to shareholders who are registered by the close of business on June 17, 2024.

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-522 trial met its overall survival (OS) endpoint for patients with high-risk early-stage triple-negative breast cancer (TNBC) using KEYTRUDA (pembrolizumab). The regimen, combining pre-operative chemotherapy with subsequent monotherapy, showed a statistically significant improvement in OS. The safety profile was consistent with previous studies, with no new safety signals. KEYTRUDA is now the first immunotherapy-based treatment to provide a survival benefit over chemotherapy alone in this patient group. These results, building on previous positive outcomes, will be presented at a medical meeting and shared with regulatory authorities.