Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has announced two significant shareholder-focused initiatives. The company's Board of Directors has declared a quarterly dividend of $0.81 per share for the second quarter of 2025, which will be paid on April 7, 2025, to shareholders of record as of March 17, 2025. Additionally, the Board has authorized a new $10 billion share repurchase program with no time limit for completion.

Merck (MRK) announced the FDA's acceptance of a priority review for WELIREG® (belzutifan) to treat advanced pheochromocytoma and paraganglioma (PPGL) in adults and pediatric patients aged 12 and older. The application is based on data from the Phase 2 LITESPARK-015 trial, with a target action date of May 26, 2025.

If approved, WELIREG would become the only available therapy in the U.S. for eligible PPGL patients. The drug is already approved as the first and only HIF-2α inhibitor for treating von Hippel-Lindau (VHL) disease-associated tumors in the U.S., China, and 16 other countries. It's also approved in the U.S. and Canada for treating advanced renal cell carcinoma following specific prior treatments.

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.