Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has received European Commission approval for WINREVAIR™ (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH) in WHO Functional Class II-III. WINREVAIR is the first activin signaling inhibitor therapy for PAH approved in Europe, designed to improve exercise capacity when used with other PAH therapies.

The approval is based on the Phase 3 STELLAR trial, which showed significant improvements in six-minute walk distance and reduced risk of death or clinical worsening. WINREVAIR demonstrated an 82% reduction in the risk of death or clinical worsening compared to background therapy alone.

WINREVAIR is administered as a subcutaneous injection every 3 weeks and can be self-administered with proper training. This approval is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway.

Merck (NYSE: MRK) has announced a definitive agreement to acquire CN201, a novel investigational clinical-stage bispecific antibody, from Curon Biopharmaceutical for an upfront payment of $700 million in cash. The deal includes potential milestone payments of up to $600 million. CN201 is a next-generation CD3xCD19 bispecific antibody currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma and B-cell acute lymphocytic leukemia.

Preliminary data suggests CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well-tolerated. Merck plans to evaluate CN201 for B-cell malignancies and autoimmune diseases. The transaction is expected to close in Q3 2024, subject to regulatory approval. Merck anticipates recording a pre-tax charge of approximately $750 million, or $0.28 per share, in non-GAAP results upon closing.

Merck (NYSE: MRK) has announced the discontinuation of its Phase 3 KeyVibe-008 trial, which was evaluating a fixed-dose combination of vibostolimab and pembrolizumab (KEYTRUDA®) with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). The decision was based on a recommendation from an independent Data Monitoring Committee after a pre-planned analysis showed the primary endpoint of overall survival met pre-specified futility criteria. Additionally, patients in the experimental arm experienced higher rates of adverse events compared to the control arm.

Despite this setback, Merck remains committed to advancing research in lung cancer treatment. The company is pursuing multiple registration-enabling studies, including the IDeate-Lung02 Phase 3 trial with Daiichi Sankyo, evaluating ifinatamab deruxtecan in relapsed SCLC. Merck is also exploring combinations with MK-6070, a DLL3-targeting T-cell engager, in SCLC patients.

Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK) have expanded their global collaboration to include MK-6070, an investigational DLL3-targeting T-cell engager. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck retains exclusive rights. This agreement builds on their existing partnership for three DXd antibody drug conjugates.

MK-6070 targets DLL3, highly expressed in small cell lung cancer (SCLC) and neuroendocrine tumors. The companies plan to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC patients. Merck will receive a $170 million upfront payment, and the companies will share R&D costs, commercialization expenses, and profits globally, except in Japan.

Daiichi Sankyo and Merck have initiated the IDeate-Lung02 phase 3 trial for ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer (SCLC). This trial will evaluate the efficacy and safety of I-DXd compared to physician's choice of chemotherapy. I-DXd is a potential first-in-class B7-H3 directed antibody drug conjugate (ADC) jointly developed by both companies.

SCLC is an aggressive form of lung cancer with poor prognosis, accounting for 15% of lung cancer cases. The trial's initiation is based on promising results from a subgroup analysis of the IDeate-PanTumor01 phase 1/2 trial presented at the 2023 World Conference on Lung Cancer. This marks the second pivotal study in the Daiichi Sankyo-Merck collaboration, following the REJOICE-Ovarian01 phase 2/3 study for raludotatug deruxtecan.

Merck (NYSE: MRK) reported strong second-quarter 2024 financial results with total worldwide sales of $16.1 billion, a 7% increase year-over-year. Excluding foreign exchange impacts, growth was 11%. KEYTRUDA sales grew 16% to $7.3 billion. GAAP EPS was $2.14, while Non-GAAP EPS was $2.28. The company successfully launched WINREVAIR in the US and received a positive EU opinion for adults with PAH. Merck also achieved significant milestones with its vaccines and announced positive trial results for clesrovimab.

Merck completed acquisitions of EyeBio and Elanco’s Aqua Business and raised its full-year 2024 financial outlook to $63.4-$64.4 billion in sales and expects Non-GAAP EPS between $7.94 and $8.04. The outlook reflects a one-time charge of $1.3 billion for the EyeBio acquisition.

Quarterly results highlighted a 7% increase in pharmaceutical sales driven by oncology, cardiovascular, and vaccine growth, despite declines in diabetes and virology segments. Animal Health sales rose 2%, with notable increases in Livestock products. GAAP net income was $5.46 billion compared to a loss of $5.98 billion last year.

Merck (NYSE: MRK) received a positive opinion from the European Medicines Agency's CHMP for KEYTRUDA in combination with Padcev as a first-line treatment for unresectable or metastatic urothelial carcinoma. The recommendation is based on the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy:

- 53% reduction in risk of death
- 55% reduction in risk of disease progression or death

A final decision by the European Commission is expected in Q3 2024. If approved, this will be KEYTRUDA's third bladder cancer indication in the EU. The combination was already approved in the U.S. in December 2023.

Merck (NYSE: MRK) has announced its quarterly dividend for the fourth quarter of 2024. The Board of Directors has declared a dividend of $0.77 per share of the company's common stock. This dividend will be paid on October 7, 2024, to shareholders who are on record at the close of business on September 16, 2024. Merck, also known as MSD outside of the United States and Canada, continues to provide returns to its shareholders through consistent dividend payments, demonstrating the company's financial stability and commitment to investor value.

Merck (NYSE: MRK) has announced positive topline results from its Phase 2b/3 clinical trial of clesrovimab (MK-1654), an investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. The trial met all primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150.

Merck plans to present detailed findings at an upcoming scientific congress and file the data with global regulatory authorities. Dr. Paula Annunziato, senior vice president at Merck Research Laboratories, emphasized the significance of these results, noting that RSV is the leading cause of hospitalization for healthy infants globally.