Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has announced that two of its top executives will participate in an upcoming healthcare conference. Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, are scheduled to engage in a fireside chat at the TD Cowen 45th Annual Health Care Conference.

The event is scheduled for Monday, March 3, 2025, at 2:30 p.m. EST. The company has made the session accessible to investors, analysts, media representatives, and the general public through a live audio webcast, which will be available via a provided weblink.

Merck (MRK) has received European Commission conditional approval for WELIREG® (belzutifan), the first oral HIF-2α inhibitor in the EU, for two indications: treatment of adult patients with von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC).

The approval is based on the LITESPARK-004 and LITESPARK-005 trials. In VHL disease-associated RCC patients, WELIREG showed a 49% objective response rate. For CNS hemangioblastomas, the response rate was 63%, and for pNET, it reached 83%. In advanced RCC patients, WELIREG reduced disease progression or death risk by 25% versus everolimus, with a 22% objective response rate compared to 4% for everolimus.

The conditional approval will be valid for one year, subject to yearly renewal pending additional clinical data. WELIREG is now approved in over 30 countries for certain advanced RCC patients and in more than 40 countries for VHL disease-associated tumors.

Merck (MRK) has initiated waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with R-CHP compared to R-CHOP alone for previously untreated diffuse large B-cell lymphoma (DLBCL) patients. The trial, which has begun global recruitment, will enroll approximately 1,046 patients.

Zilovertamab vedotin is Merck's investigational antibody-drug conjugate targeting ROR1. The study's primary endpoint is progression-free survival, with secondary endpoints including complete response rate, overall survival, event-free survival, duration of complete response, and safety.

The initiation follows encouraging results from the Phase 2 waveLINE-007 trial. The drug is also being evaluated in the Phase 2/3 waveLINE-003 trial for relapsed or refractory DLBCL. Initial data was presented at the 66th American Society of Hematology Annual Meeting in December 2024.

Merck (MRK) reported strong financial results for Q4 and full-year 2024. Fourth-quarter worldwide sales reached $15.6 billion, up 7% (9% ex-forex) from Q4 2023, while full-year sales hit $64.2 billion, increasing 7% (10% ex-forex) from 2023.

Key performance highlights include KEYTRUDA sales growing 18% to $29.5 billion, WINREVAIR sales of $419 million, and Animal Health sales growing 4% to $5.9 billion. However, GARDASIL/GARDASIL 9 sales declined 3% to $8.6 billion.

Q4 GAAP EPS was $1.48 and non-GAAP EPS was $1.72, both including a $0.23 per share charge related to business development transactions. Full-year 2024 GAAP EPS was $6.74, while non-GAAP EPS reached $7.65.

For 2025, Merck expects worldwide sales between $64.1-65.6 billion and non-GAAP EPS of $8.88-9.03, including a one-time charge of approximately $0.09 per share for an anticipated milestone payment.

Merck (NYSE: MRK) announced the early termination of its Phase 3 HYPERION trial evaluating WINREVAIR versus placebo in adults with pulmonary arterial hypertension (PAH). The decision was based on positive results from the interim analysis of the ZENITH trial and overall WINREVAIR clinical program data.

The external steering committee and Merck determined it would be unethical to continue the placebo-controlled trial given the robust efficacy data demonstrated across patient populations. This decision will allow all study participants to access WINREVAIR through the Phase 3 SOTERIA open-label extension study.

WINREVAIR is currently approved in the U.S. and 38 countries based on Phase 3 STELLAR trial results. The complete findings from the HYPERION study will be presented at a future medical congress later this year.

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.