Merck & Co Stock Price, News & Analysis

Merck (MRK) received a positive CHMP opinion recommending conditional approval of WELIREG® (belzutifan) in the European Union for two indications: treatment of adult patients with von Hippel-Lindau (VHL) disease-associated tumors and advanced renal cell carcinoma (RCC). The recommendation is based on the LITESPARK-004 and LITESPARK-005 trials.

In LITESPARK-004, WELIREG showed significant efficacy with 49% objective response rate in VHL-associated RCC, 63% in CNS hemangioblastomas, and 83% in pancreatic neuroendocrine tumors. In LITESPARK-005, WELIREG reduced disease progression or death risk by 25% versus everolimus. A final EU decision is expected in Q1 2025.

LYNPARZA demonstrated significant long-term survival benefits in the OlympiA Phase 3 trial for early breast cancer patients. At 6.1 years median follow-up, the drug reduced death risk by 28% compared to placebo, with 87.5% of treated patients surviving versus 83.2% in the placebo group.

The trial showed LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35%, and similarly reduced the risk of distant disease recurrence. The drug maintained its established safety profile with no new safety signals identified during the extended follow-up period.

LYNPARZA is currently approved in multiple countries for treating germline BRCA-mutated, HER2-negative high-risk early breast cancer, based on these OlympiA trial results.

Merck (MRK) announced positive results from its Phase 3 KEYLYNK-001 trial, evaluating KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for BRCA non-mutated advanced epithelial ovarian cancer. The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone.

However, the study did not reach its secondary endpoint of overall survival (OS), and the role of KEYTRUDA in the intention-to-treat population remains uncertain. The safety profiles were consistent with previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Merck (MRK) announced promising results from its Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin combined with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). The trial achieved a 100% complete response rate in patients treated with the 1.75 mg/kg dose, which has been established as the recommended Phase 3 dose.

The study enrolled 36 patients across three dosage groups (1.75, 2.0, and 2.25 mg/kg). The total complete response rate was 97.2%, with a median follow-up of 17.6 months. The 12-month duration of response was 93.5%. Serious treatment-related adverse events occurred in 11% of patients, with Grade 3-4 adverse events reported in 58% of patients, primarily including neutropenia, nausea, anemia, and diarrhea.

Merck (NYSE:MRK) has achieved the top position on Newsweek's America's Most Responsible Companies 2025 list for the second consecutive year. The ranking was determined through Statista's analysis of 2,000 largest U.S. public companies, evaluating 30 key performance indicators and incorporating feedback from 26,000 U.S. residents.

Chairman and CEO Robert M. Davis emphasized the company's commitment to ethics and integrity as fundamental to their mission of saving and improving lives. Additionally, Merck secured the #1 position in its industry on CNBC and JUST Capital's America's Most JUST Companies list and Barron's 100 Most Sustainable U.S. Companies rankings.

Merck (MRK) and Ridgeback Biotherapeutics have initiated the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIO™ (molnupiravir) for treating high-risk adults with COVID-19. The study targets adults who tested positive for SARS-CoV-2, have had symptoms for four days or less, and cannot receive nirmatrelvir/ritonavir due to various contraindications.

The trial will test a new formulation of LAGEVRIO using two 400-mg tablets per dose instead of four 200-mg capsules. The medication is currently approved or authorized in several countries, including Japan, Australia, and the US under emergency use authorization, and has been used by over 8.3 million patients worldwide.

Merck (MRK) announced that the FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced nonsquamous non-small cell lung cancer (NSCLC) with specific EGFR mutations. This designation is based on Phase 2 study data presented at the 2023 ASCO Annual Meeting. The company is advancing a global clinical development program with 10 ongoing Phase 3 studies across various solid tumors. Sac-TMT recently received its first marketing authorization in China for treating triple-negative breast cancer. The breakthrough designation may expedite development and review processes, with potential eligibility for Priority Review.

Merck (NYSE: MRK) has announced that its chairman and CEO Robert M. Davis, along with Dr. Eliav Barr, senior vice president and chief medical officer of Merck Research Laboratories, will participate in a fireside chat at the Citi 2024 Global Healthcare Conference. The event is scheduled for Thursday, December 5, 2024, at 8:00 a.m. EST. A live audio webcast of the presentation will be available to investors, analysts, media members, and the general public.

Merck (NYSE: MRK) announced positive topline results from the Phase 3 ZENITH study of WINREVAIR in adults with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality. The study met its primary endpoint, demonstrating a statistically significant reduction in the risk of morbidity or mortality events compared to placebo. Due to overwhelming efficacy, the independent monitoring committee recommended early study termination, with all participants being offered WINREVAIR through the SOTERIA open-label extension study. WINREVAIR is currently approved in the U.S. and 36 countries based on Phase 3 STELLAR trial results.