Welcome to our dedicated page for Merck & Co news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co stock.
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, generates frequent news across human health, animal health and corporate finance. As a research-intensive biopharmaceutical company with more than a century of history developing medicines and vaccines, Merck regularly announces clinical trial milestones, regulatory decisions, business development transactions and capital markets activity.
Recent news highlights include oncology updates from Merck’s extensive KEYTRUDA program, such as positive Phase 3 data in muscle-invasive bladder cancer and new trials in non-small cell lung cancer using combinations like calderasib (MK-1084) with KEYTRUDA QLEX. The company also reports on progress in other therapeutic areas, including pulmonary arterial hypertension with WINREVAIR, Alzheimer’s disease candidates MK-2214 and MK-1167, and cardiovascular research with the oral PCSK9 inhibitor candidate enlicitide.
Investors following MRK news will also see announcements related to Merck Animal Health, such as the conditional U.S. FDA approval of EXZOLT CATTLE-CA1 for the prevention and treatment of New World screwworm larvae and the treatment and control of cattle fever tick, as well as updates on acquisitions like the planned merger with Cidara Therapeutics to add the influenza candidate CD388 to Merck’s respiratory portfolio.
Corporate and financial communications include quarterly earnings calls, participation in major healthcare conferences and disclosures about note offerings under the company’s shelf registration statement. This news page aggregates these developments so readers can review clinical, regulatory, strategic and financial updates related to Merck & Co., Inc. and its MRK stock in one place.
Merck (NYSE: MRK) announced the resignation of Leslie A. Brun, its independent lead director, effective August 19, 2021. Brun is stepping down to become chairman and CEO of Ariel Alternatives, a private equity initiative focused on scaling minority-owned businesses as tier 1 suppliers to Fortune 500 companies. Merck is considering an investment in Ariel Alternatives. CEO Rob Davis acknowledged Brun's contributions and expressed support for his new role. The company plans to appoint a new independent lead director soon.
Merck (NYSE: MRK) has received FDA approval for WELIREG, an oral HIF-2α inhibitor, to treat adult patients with von Hippel-Lindau (VHL) disease requiring therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). This approval marks WELIREG as the first systemic therapy for certain VHL-associated tumors in the U.S. The treatment showed a significant overall response rate (ORR) of 49% in RCC patients and is vital for addressing an unmet medical need.
Merck and Eisai announced FDA approval for the combination of KEYTRUDA and LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC). This decision is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. KEYTRUDA plus LENVIMA reduced disease progression or death by 61%, with median PFS of 23.9 months versus 9.2 months for sunitinib. 71% of patients achieved confirmed objective response rate, indicating strong efficacy for this cancer therapy.
Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, targeting advanced endometrial carcinoma with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics. This application stems from data from KEYNOTE-158, which will be discussed at the upcoming ESMO Congress. The FDA's target action date is March 28, 2022. KEYTRUDA has previously received accelerated approval for similar cancer indications and is part of Merck's expanding oncology portfolio, aimed at addressing challenging women's cancers.
Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, its anti-PD-1 therapy, for the adjuvant treatment of renal cell carcinoma (RCC) patients at high risk of recurrence post-nephrectomy. This priority review is based on pivotal Phase 3 KEYNOTE-564 trial data, showing significant improvement in disease-free survival compared to placebo. The PDUFA target action date is set for December 10, 2021. Merck continues to explore KEYTRUDA across various settings in RCC, with over 20 clinical studies involving more than 4,000 patients globally.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-716 trial for KEYTRUDA, an anti-PD-1 therapy, successfully met its primary endpoint of recurrence-free survival (RFS) in high-risk stage II melanoma patients after complete surgical resection. The interim analysis showed significant RFS improvement compared to placebo, with no new safety concerns reported. The FDA has accepted a supplemental Biologics License Application for KEYTRUDA in this indication, granting it Priority Review with a target action date of December 4, 2021. This marks a critical step in advancing melanoma treatment.
Merck (NYSE: MRK) announced the appointment of Cristal N. Downing as chief communications & public affairs officer, effective August 16, 2021. This new role within the Executive Team emphasizes enhanced communication strategies. CEO Rob Davis praised Downing's transformational leadership and experience in biopharmaceuticals, highlighting her previous role at Johnson & Johnson, where she led communication strategies and health equity initiatives. The company aims to strengthen its strategic impact and continue delivering essential innovations amid a growing focus on biopharmaceutical advancement.
Merck (NYSE: MRK) reported strong Q2 2021 results, with sales rising 22% to $11.4 billion. Non-GAAP EPS increased by 28% to $1.31, while GAAP EPS fell 48% to $0.48, impacted by a $1.7 billion charge for Pandion acquisition. KEYTRUDA sales were a highlight, growing 23% to $4.2 billion. Regulatory approvals for KEYTRUDA and Lynparza were announced, enhancing their oncology portfolio. Full-year guidance projects revenue between $46.4 and $47.4 billion, with an EPS range of $4.24 to $4.34. COVID-19's impact is expected to wane.
Merck (NYSE: MRK) announced a quarterly dividend of $0.65 per share for Q4 2021, payable on October 7, 2021 to shareholders of record on September 15, 2021. This decision reflects the company's ongoing commitment to returning value to shareholders while maintaining its focus on innovation in various therapeutic areas, including cancer and infectious diseases. Merck has been a leader in the biopharmaceutical industry for over 130 years, dedicated to improving lives through its medicines and vaccines.
Merck (NYSE: MRK) announced promising overall survival (OS) results from the Phase 3 KEYNOTE-355 trial for KEYTRUDA, its anti-PD-1 therapy, combined with chemotherapy for metastatic triple-negative breast cancer (mTNBC). The final analysis revealed a significant improvement in OS for patients whose tumors expressed PD-L1 (CPS ≥10) compared to chemotherapy alone. No new safety signals were detected. Merck is committed to expanding treatment options for this challenging cancer type, with these results expected to be presented at a major medical meeting and submitted to regulatory authorities.