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) achieved a significant legal victory as the U.S. District Court for the Northern District of West Virginia ruled in its favor in a patent infringement lawsuit against Viatris concerning sitagliptin, an active ingredient in JANUVIA and JANUMET. The court upheld the validity of two Merck patents, with expiration dates set for 2026 and 2029. Viatris aims to launch generic versions but faces challenges following this ruling. Merck has already settled agreements allowing generics to enter the market by May 2026. This decision is subject to appeal.
Merck (NYSE: MRK) announced the resumption of a Phase 2 study on an investigational weekly oral combination treatment of islatravir and lenacapavir for HIV-1, using a lower dose of islatravir. Merck will discontinue its monthly oral islatravir development for pre-exposure prophylaxis (PrEP) but plans to initiate a new Phase 3 clinical program for once-daily islatravir and doravirine. The FDA has approved this new approach, highlighting Merck's commitment to HIV treatment.
Merck (NYSE: MRK) has received a positive recommendation from the European Medicines Agency’s CHMP for its pneumococcal vaccine VAXNEUVANCE. The vaccine, which targets Streptococcus pneumoniae, is aimed at infants and children aged 6 weeks to under 18 years, complementing existing approvals for older populations. A final decision from the European Commission is anticipated by year-end 2023. Merck's commitment to combating pneumococcal disease continues, highlighting its focus on developing vaccines for various demographics against serious infections.
Seagen, Astellas, and Merck announced promising results from the phase 1b/2 EV-103 trial, showcasing a 64.5% confirmed objective response rate (ORR) in patients with unresectable locally advanced or metastatic urothelial cancer treated with enfortumab vedotin and pembrolizumab. The primary endpoint was met with significant responses including 10.5% complete responses. The median overall survival (OS) was 22.3 months. The trial highlights the potential of this combination therapy for patients ineligible for cisplatin chemotherapy. Discussions with regulatory authorities are planned.
Astellas, Seagen, and Merck announced significant findings from the phase 1b/2 EV-103 trial, highlighting a 64.5% confirmed objective response rate in unresectable advanced urothelial cancer patients treated with enfortumab vedotin and pembrolizumab. This combination demonstrated promising efficacy as a first-line treatment, with 10.5% achieving complete response. Additionally, median overall survival reached 22.3 months for the combination group. Adverse events mainly included skin reactions and neuropathy. The companies plan to discuss results with regulatory authorities and pursue further studies.
Merck (NYSE: MRK) announced promising five-year survival data for KEYTRUDA in treating metastatic non-small cell lung cancer (NSCLC). In KEYNOTE-189, KEYTRUDA plus chemotherapy achieved a five-year overall survival (OS) rate of 19.4%, significantly higher than 11.3% for chemotherapy alone. KEYNOTE-407 reported a five-year OS rate of 18.4% for KEYTRUDA plus chemotherapy versus 9.7% for chemotherapy alone. These results affirm KEYTRUDA's role as a first-line treatment, demonstrating improved overall survival and durable responses, significantly altering the treatment landscape for NSCLC.
Merck (MRK) and Eisai presented findings from the Phase 3 LEAP-002 trial at the ESMO Congress 2022. The study evaluated the combination of KEYTRUDA and LENVIMA against LENVIMA alone for unresectable hepatocellular carcinoma (uHCC). The final analysis showed a median overall survival (OS) of 21.2 months for the combination versus 19.0 months for monotherapy, but results did not reach statistical significance. The trial highlights the need for further research into this combination therapy.
AstraZeneca and Merck announced long-term results from the Phase 3 PAOLA-1 and SOLO-1 trials for LYNPARZA in advanced ovarian cancer. The PAOLA-1 trial showed that, in HRD-positive patients, overall survival was 65.5% for LYNPARZA plus bevacizumab versus 48.4% for bevacizumab alone. In the SOLO-1 trial, 67% of patients with BRCA mutations treated with LYNPARZA were alive at seven years compared to 47% on placebo. Both trials highlighted the importance of biomarker testing in treatment decisions. While the OS results were not statistically significant for the PAOLA-1 trial overall, HRD-positive subgroup showed a 38% reduced risk of death.
The Merck Foundation has launched the Alliance for Equity in Cancer Care, a $20 million, five-year initiative aimed at improving cancer care for underserved communities in the United States. The program addresses disparities in cancer access and treatment, providing grants to non-profit organizations to implement innovative programs. Nearly 40% of Americans are expected to be diagnosed with cancer, with minority and low-income groups disproportionately affected. The Foundation aims to improve coordination of care and patient engagement, enhancing overall health outcomes.
Merck (NYSE: MRK) announced that CEO Robert M. Davis and Dr. Dean Li will participate in a virtual fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 2:15 p.m. EDT. The session invites investors, analysts, and the public to listen via a live audio webcast. Merck, known as MSD internationally, focuses on leading-edge science to improve global health and has been a key player in pharmaceuticals for over 130 years.