Merck & (MRK) Stock News

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.

Merck has initiated construction of a $1 billion biologics center in Wilmington, Delaware. The 470,000-square-foot facility will serve as a launch and commercial production site for next-generation biologics, including KEYTRUDA for U.S. patients.

The new center at Chestnut Run Innovation & Science Park will create over 500 full-time positions and 4,000 construction jobs. Laboratory operations are expected to begin by 2028, with production starting in 2030. Future expansion could add 1,500 more full-time roles and 26,000 construction jobs.

This investment is part of Merck's larger U.S. manufacturing commitment, which includes:

• $12 billion already allocated for domestic manufacturing enhancement
• $9 billion planned for the next four years
• A recently completed $1 billion vaccine facility in Durham, North Carolina
• $3.5 billion planned for biologics and small molecule manufacturing

Merck (NYSE: MRK) announced groundbreaking results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® for treating locally advanced head and neck squamous cell carcinoma (LA-HNSCC). After a median follow-up of 38.3 months, KEYTRUDA significantly improved event-free survival, reducing risk by 27% in the intent-to-treat population compared to standard care alone.

Key findings include:

• Median event-free survival was 51.8 months for KEYTRUDA plus standard of care versus 30.4 months for standard care alone
• Risk reduction was even higher (34%) in patients with Combined Positive Score ≥10
• The trial showed significant improvement in major pathological response rates

This marks the first positive trial in over two decades for resectable LA-HNSCC patients. The FDA is reviewing KEYTRUDA for this indication under priority review, with a target action date of June 23, 2025. The safety profile remained consistent with previous studies, with no new safety signals identified.

Merck (MRK) reported Q1 2025 financial results with total worldwide sales of $15.5 billion, showing a 2% decrease from Q1 2024, though growing 1% excluding foreign exchange impact.

Key performance highlights include:

• KEYTRUDA sales grew 4% to $7.2 billion
• WINREVAIR achieved sales of $280 million
• Animal Health sales increased 5% to $1.6 billion
• GARDASIL/GARDASIL 9 sales declined 41% to $1.3 billion

The company reported GAAP EPS of $2.01 and Non-GAAP EPS of $2.22. For full-year 2025, Merck expects worldwide sales between $64.1-65.6 billion and revised Non-GAAP EPS to $8.82-8.97, reflecting a one-time charge related to the Hengrui Pharma agreement and additional tariff costs of $200 million.

Merck (NYSE: MRK) has scheduled its first-quarter 2025 sales and earnings conference call for Thursday, April 24, at 9:00 a.m. ET. The call will feature company executives presenting an overview of Merck's quarterly performance to institutional investors and analysts.

Participants can access the live audio webcast through a provided weblink, with a replay available later at www.merck.com along with the earnings release, supplemental financial disclosures, and results slides. Interested parties can also join via phone using the toll-free number (800) 369-3351 for U.S. and Canada, or (517) 308-9448, with access code 9818590.