Merck & (MRK) Stock News

Daiichi Sankyo and Merck (MRK) have voluntarily withdrawn their Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The withdrawal follows topline overall survival results from the HERTHENA-Lung02 phase 3 trial that failed to meet statistical significance. While the trial showed statistically significant progression-free survival (PFS), the overall survival data did not reach the required threshold. The decision is unrelated to a previous Complete Response Letter from June 2024 regarding third-party manufacturing facility inspection findings. The companies will present detailed trial results at the 2025 ASCO Annual Meeting. The safety profile remained consistent with previous trials, with no new safety signals identified.

Merck (NYSE: MRK) has announced its quarterly dividend payment for Q3 2025. The company's Board of Directors has declared a dividend of $0.81 per share of common stock. The dividend will be paid on July 8, 2025, to shareholders who are on record as of the close of business on June 16, 2025.

Merck (MRK) and Daiichi Sankyo have initiated the IDeate-Esophageal01 Phase 3 trial for ifinatamab deruxtecan (I-DXd), a potential first-in-class B7-H3 directed antibody drug conjugate. The trial will evaluate I-DXd versus standard chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed after platinum therapy and immunotherapy. ESCC represents 90% of global esophageal cancers with a dire 15-20% five-year survival rate. The trial's initiation follows promising results from the IDeate-PanTumor01 phase 1/2 trial presented at ESMO 2022 and 2023, which demonstrated encouraging responses in heavily pretreated ESCC patients.

<p><b>Merck (MRK)</b> announced it will present new clinical and outcomes research data on <b>pulmonary arterial hypertension (PAH)</b> at the ATS 2025 International Conference in San Francisco. The company will showcase nine presentations, including a significant pooled analysis of WINREVAIR™ (sotatercept-csrk) from the PULSAR, SPECTRA, and STELLAR studies, along with the ongoing SOTERIA open-label extension study.</p><p>Key presentations will feature long-term safety data, overall survival analysis, and research on PAH's impact across various patient populations. The data represents the largest analysis of WINREVAIR to date, evaluating its safety, tolerability, and efficacy when combined with background therapy for PAH treatment.</p>

Merck (NYSE: MRK) announced positive results from its Phase 3 KEYNOTE-B96 trial evaluating KEYTRUDA (pembrolizumab) in combination with chemotherapy for platinum-resistant recurrent ovarian cancer. The trial met its primary endpoint of progression-free survival (PFS) in both PD-L1 expressing tumors and all comers. Significantly, the study achieved a secondary endpoint of overall survival (OS) in PD-L1 expressing tumors - marking the first time an immune checkpoint inhibitor-based regimen demonstrated an OS benefit in ovarian cancer. The KEYTRUDA-based treatment showed statistically significant improvements compared to placebo plus chemotherapy, with a safety profile consistent with previous studies. While KEYTRUDA is not yet approved for ovarian cancer treatment, these breakthrough results suggest potential new treatment options for this difficult-to-treat condition.

The FDA has approved Merck's (MRK) WELIREG® (belzutifan) for treating adults and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This marks WELIREG's third indication in the U.S. and establishes it as the only approved and available treatment for eligible PPGL patients. PPGL is a rare condition affecting up to 2,000 people annually in the U.S. The approval is based on the LITESPARK-015 clinical trial, which enrolled 72 patients. The drug targets hypoxia-inducible factor-2 alpha (HIF-2α) and is administered orally at 120 mg once daily. Important safety considerations include risks during pregnancy, potential for severe anemia requiring blood transfusion, and possible severe hypoxia requiring discontinuation, supplemental oxygen, or hospitalization.

Merck (NYSE: MRK) will present extensive research from its oncology portfolio at the ASCO Annual Meeting (May 30-June 3, 2025), covering over 25 cancer types. Key highlights include first-time data for MK-1084, their KRAS G12C inhibitor, from the KANDLELIT-001 study in colorectal cancer and NSCLC. The company will showcase data on novel antibody-drug conjugates including zilovertamab vedotin and sacituzumab tirumotecan. Important updates include 5-year follow-up results for KEYTRUDA in renal cell carcinoma (KEYNOTE-564 trial) and WELIREG in VHL disease-associated tumors. Primary results from ASCENT-04/KEYNOTE-D19 trial evaluating KEYTRUDA plus sacituzumab govitecan-hziy in triple-negative breast cancer will be featured in ASCO's press program. Merck will host an Oncology Investor Event on June 2, 2025, to discuss their oncology strategy.

Merck Animal Health (NYSE: MRK) has announced an $895 million expansion of its facilities in De Soto, Kansas, marking its largest economic development project in recent history. The investment includes $860 million for expanding the existing manufacturing facility and $35 million for research and development laboratories.

The 200,000-square-foot manufacturing expansion will enhance filling and freeze dryer capacity for large molecule vaccines and biologic products. Site preparation begins immediately, creating 2,500 construction jobs, with commercial manufacturing expected to start in 2030, generating over 200 full-time positions. Located in the Animal Health Corridor, this investment is part of Merck's broader commitment to invest more than $21 billion in domestic manufacturing and research capabilities between 2017 and 2028.

Merck (NYSE: MRK) announced that two key executives will participate in a fireside chat at the Bank of America 2025 Global Healthcare Conference. The presenters will be Jannie Oosthuizen, president of Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories. The presentation is scheduled for Wednesday, May 14, 2025, at 10:40 a.m. PDT / 1:40 p.m. EDT. The company will provide a live audio webcast of the presentation, which will be accessible to investors, analysts, media, and the general public.