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) has partnered with the Bill & Melinda Gates Foundation to fund a Phase 3 study, IMPOWER 22, to explore a once-monthly oral pre-exposure prophylaxis (PrEP) for HIV-1 in high-risk women and adolescent girls in sub-Saharan Africa. Islatravir, Merck’s investigational antiviral, will be tested for its safety and efficacy. With women representing nearly 60% of new infections in this region, this initiative aims to provide a significant preventive option and advance HIV science globally.
Merck (NYSE: MRK) announced FDA approval for KEYTRUDA in combination with chemotherapy for treating locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) with PD-L1 expression (CPS ≥10). This decision is based on the Phase 3 KEYNOTE-355 trial, demonstrating a 35% reduction in disease progression or death compared to chemotherapy alone. KEYTRUDA’s introduction offers a new option for TNBC patients, which affects 15-20% of breast cancer cases. However, this approval is under accelerated conditions pending further clinical evidence.
Merck (NYSE: MRK) and Eisai announced significant results from the Phase 3 KEYNOTE-581/CLEAR trial, demonstrating that KEYTRUDA® (pembrolizumab) combined with LENVIMA® (lenvatinib) provides superior progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to sunitinib in first-line treatment of advanced renal cell carcinoma (RCC). The study also showed LENVIMA plus everolimus met PFS and ORR endpoints versus sunitinib. Both combinations exhibited safety profiles consistent with prior studies, with plans for regulatory submissions based on these findings.
Pappas Capital announced the acquisition of its portfolio company VelosBio Inc. by Merck (NYSE: MRK) for $2.75 billion in cash. VelosBio, a clinical-stage biopharmaceutical firm, develops innovative cancer therapies targeting ROR1. Pappas Capital has invested in VelosBio since 2018, including a $137 million Series B financing in July 2020. The acquisition aims to advance VelosBio's investigational drug, VLS-101, currently in clinical trials for treating hematologic malignancies and solid tumors. This strategic move marks a significant milestone for both Pappas Capital and VelosBio.
AstraZeneca and Merck announced that LYNPARZA has been approved in the EU for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations. This approval is based on the PROfound trial, which demonstrated significant improvement in radiographic progression-free survival (9.8 months vs. 3.0 months) and overall survival (20.1 months vs. 14.4 months) compared to enzalutamide or abiraterone. The approval highlights the importance of BRCA testing in treatment decisions for advanced prostate cancer.
AstraZeneca and Merck announced EU approval for LYNPARZA combined with bevacizumab for maintenance treatment of advanced ovarian cancer patients with HRD-positive status. This decision is based on the PAOLA-1 Phase 3 trial, showing a 67% reduction in disease progression risk when compared to bevacizumab alone, with median progression-free survival rising to 37.2 months. Despite serious adverse reactions reported, including fatigue and anemia, the approval underscores the importance of HRD testing in treatment selection. AstraZeneca will receive $25 million from Merck following this collaboration.
Merck (NYSE: MRK) announced its acquisition of VelosBio Inc. for $2.75 billion in cash, aiming to enhance its oncology portfolio. VelosBio specializes in first-in-class cancer therapies, focusing on VLS-101, an antibody-drug conjugate targeting ROR1. This acquisition aligns with Merck's strategy to expand its cancer treatment options, as VLS-101 shows promising clinical results in treating hematologic malignancies. The transaction is expected to close by the end of 2020, pending regulatory approvals.
Merck (MRK) reported third-quarter 2020 sales of $12.6 billion, a 1% increase from the previous year. GAAP net income rose 55% to $2.9 billion, with GAAP EPS at $1.16. Non-GAAP net income increased 14% to $4.4 billion, and Non-GAAP EPS rose 16% to $1.74. Despite a COVID-19 impact estimated at $475 million on revenues, product demand remains strong. Keytruda sales surged 21% to $3.7 billion. The company announced advancements in its COVID-19 research programs and oncology pipeline, including multiple Phase 2/3 trials for Molnupiravir and achievements with Keytruda.
Merck (NYSE: MRK) announced today details of new clinical and epidemiological data set to be presented at IDWeek 2020, taking place from Oct. 21 to 25, 2020. Highlights include Phase 3 RESTORE-IMI 2 trial results for RECARBRIO™ in treating hospital-acquired or ventilator-associated bacterial pneumonia and safety assessments of PIFELTRO™ and DELSTRIGO™ for HIV-1 patients aged 50 and older. Additionally, Merck will share insights from studies on antimicrobial resistance and vaccination strategies, emphasizing its commitment to advancing research against infectious diseases.
Merck (NYSE: MRK) announced results from two Phase 3 studies on V114, its 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH study, V114 produced comparable immune responses to PCV13 in healthy adults 50+, with higher responses for serotypes 22F and 33F. The PNEU-DAY study showed similar findings in immunocompetent adults 18-49 with risk factors. V114 was well tolerated with a safety profile consistent with earlier studies. Plans for regulatory applications, starting with the FDA, are set for this year.
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