Merck & Co Stock Price, News & Analysis

Merck (MRK) and Eisai announced mixed results from their Phase 3 LEAP-015 trial evaluating KEYTRUDA® plus LENVIMA® in combination with chemotherapy for first-line treatment of HER2-negative gastroesophageal adenocarcinoma. The treatment demonstrated statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to standard chemotherapy. However, the study did not meet its primary endpoint of overall survival (OS).

The safety profile remained consistent with previously reported studies. The combination is currently approved in multiple countries for treating advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. The companies confirmed these results do not affect current approved indications or ongoing trials from the LEAP clinical program.

Merck (NYSE: MRK) has announced its upcoming fourth-quarter and full-year 2024 sales and earnings conference call, scheduled for February 4, 2025, at 9:00 a.m. ET. The call will feature company executives presenting Merck's Q4 performance and providing guidance for 2025.

The event will be accessible to institutional investors, analysts, journalists, and the general public through a live audio webcast. Participants can also join via phone using the toll-free numbers: (800) 369-3351 (U.S. and Canada) or (517) 308-9448, with access code 9818590. A replay of the webcast, along with financial disclosures and presentation slides, will be available on Merck's website.

Merck (MRK) announced that China's National Medical Products Administration (NMPA) has approved GARDASIL for males aged 9-26 years, making it the first HPV vaccine approved for males in China. The vaccine helps prevent certain HPV-related cancers and diseases, including anal cancers caused by HPV Types 16 and 18, and genital warts caused by HPV Types 6 and 11.

GARDASIL has already protected over 50 million females in China from HPV-related cancers and diseases. The vaccine is indicated for females aged 9-45 and males aged 9-26. It requires a complete vaccination regimen of 3 doses administered at 0, 2, and 6 months. The vaccine does not eliminate the need for cancer screening and doesn't protect against HPV types not covered by the vaccine or pre-existing HPV infections.

Merck (NYSE: MRK) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's chairman and CEO Robert M. Davis, along with Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, will engage in a fireside chat scheduled for Monday, Jan. 13, 2025, at 4:30 p.m. PST / 7:30 p.m. EST.

The event will be accessible to investors, analysts, media representatives, and the general public through a live audio webcast. Interested parties can access the presentation through the provided weblink.

Merck (MRK) has finalized an exclusive global license agreement with LaNova Medicines for LM-299, a novel investigational PD-1/VEGF bispecific antibody. The deal includes an upfront payment of $588 million, which will result in a pre-tax charge of approximately $0.18 per share in Merck's Q4 2024 results. LaNova could receive up to $2.7 billion in milestone payments, including $300 million upon technology transfer expected in 2025. Under the agreement, Merck will handle the development, manufacturing, and commercialization of LM-299.

Merck (MRK) announced positive topline results from two pivotal Phase 3 trials evaluating its investigational once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for treating adults with virologically suppressed HIV-1 infection. The trials met their primary efficacy endpoints, demonstrating non-inferiority to baseline antiretroviral therapy and bictegravir/emtricitabine/tenofovir alafenamide.

The DOR/ISL (100 mg/0.25 mg) combination showed comparable safety profiles to other therapies in both trials. While superiority criteria were not met in trial MK-8591A-052, the company plans to present detailed findings at a future scientific congress and submit data to regulatory authorities.

Merck (NYSE: MRK) has entered into an exclusive global license agreement with Hansoh Pharma for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. Under the agreement, Merck will pay $112 million upfront and up to $1.9 billion in potential milestone payments, plus royalties on sales. Hansoh retains rights to co-promote or solely commercialize the drug in China under certain conditions.

The deal will result in a pre-tax charge of $112 million ($0.04 per share) in Merck's Q4 2024 GAAP and non-GAAP results. The partnership aims to leverage Merck's experience in incretin biology to evaluate HS-10535's potential for cardiometabolic benefits beyond weight reduction.

Merck (MRK) announced FDA acceptance of its Biologics License Application (BLA) for clesrovimab, a long-acting monoclonal antibody designed to protect infants from RSV disease. The FDA set a target action date of June 10, 2025.

The application is supported by results from the Phase 2b/3 CLEVER trial and interim results from the ongoing Phase 3 SMART trial, which evaluated clesrovimab's safety and efficacy in healthy preterm and full-term infants. If approved, clesrovimab would be the first and only single dose immunization for infants regardless of weight, protecting them throughout their first RSV season.

Merck anticipates making clesrovimab available for ordering by July 2025, in time for the 2025-26 RSV season.

Merck (MRK) announced the discontinuation of clinical development programs for two investigational drugs: vibostolimab (anti-TIGIT antibody) and favezelimab (anti-LAG-3 antibody), both being tested in combination with pembrolizumab. The decision follows the failure of Phase 3 KeyVibe-003 and KeyVibe-007 trials in non-small cell lung cancer patients, which met pre-specified futility criteria for overall survival.

The company is also terminating the Phase 3 KEYFORM-008 trial for favezelimab in classical Hodgkin lymphoma patients. While no new safety concerns were identified, the fixed-dose combinations showed more immune-related adverse events than pembrolizumab alone. Merck will prioritize other candidates in its oncology pipeline, with ongoing data analyses to be shared with the scientific community.