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) and Eisai announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for the combination of KEYTRUDA and LENVIMA. This therapy targets advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC), showing significant improvements in overall survival (OS) and progression-free survival (PFS) in clinical trials. In the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA reduced the risk of death by 34% and disease progression by 61% compared to sunitinib. The decision from the European Commission is expected by Q4 2021.
Merck (NYSE: MRK) announced that the European Medicines Agency’s CHMP has recommended the approval of VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine, for immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. This recommendation is pending review by the European Commission, with a decision expected by year-end. VAXNEUVANCE is already FDA-approved in the U.S. for similar indications. The vaccine addresses the growing global prevalence of pneumococcal disease, particularly among vulnerable populations.
Holocene Advisors, a significant shareholder of Acceleron Pharma (XLRN), announced it will not tender its shares into Merck's (MRK) $180 per share offer. Holocene stated that the offer undervalues Acceleron, based on analysis and its strong pipeline, particularly the drug sotatercept, which shows promise for treating pulmonary arterial hypertension and could generate substantial sales. Holocene expressed concerns that proceeding with the current offer would deprive XLRN shareholders of significant value and highlighted the potential for increased value as more clinical data becomes available.
Merck (NYSE: MRK) has received FDA approval for KEYTRUDA in combination with chemotherapy, with or without bevacizumab, as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1). The approval is based on Phase 3 KEYNOTE-826 trial results, demonstrating improved overall survival (OS) and progression-free survival (PFS) with KEYTRUDA compared to chemotherapy alone. This marks an important advancement in treatment options for women with cervical cancer, particularly given the low survival rates in this population.
Merck (NYSE: MRK) has launched a cash tender offer for all outstanding shares of Acceleron Pharma Inc. (NASDAQ: XLRN), following their definitive acquisition agreement announced on Sept. 30, 2021.
Stockholders of Acceleron will receive $180 per share upon successful closing. The tender offer expires at 5:00 p.m. ET on Nov. 10, 2021. The deal is contingent upon receiving regulatory approvals and the majority of Acceleron shares being tendered.
Organon (NYSE: OGN) announced FDA clearance for its updated Jada® System, designed to treat abnormal postpartum uterine bleeding effectively. Postpartum hemorrhage cases have risen significantly in the U.S. The updated system features a new kit configuration and improved ease of use, enhancing treatment options in maternal health. The reconfigured Jada system is set to be available in January 2022. This strategic move follows Organon's acquisition of Alydia Health, reinforcing its commitment to women's health.
Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. FDA for molnupiravir, a new oral antiviral treatment for mild-to-moderate COVID-19 in high-risk adults. The decision follows positive results from the Phase 3 MOVe-OUT trial, showing a 50% reduction in hospitalization or death among treated patients compared to placebo. Merck aims to produce 10 million treatment courses by the end of 2021 and has secured supply agreements with the U.S. government and other nations, ensuring global access if authorized.
Merck (NYSE: MRK) has launched Uncovering TNBC, a docuseries aimed at addressing challenges faced by Black women diagnosed with triple-negative breast cancer (TNBC). Hosted by actress Yvonne Orji, the initiative highlights the health disparities and encourages advocacy for better health care. Black women are approximately twice as likely to develop TNBC compared to their white counterparts. The program includes a three-episode web series featuring real-life stories and educational resources tailored for Black women and their families dealing with TNBC.
Merck (NYSE: MRK) announced promising interim results from the Phase 3 MOVe-OUT trial for molnupiravir, an oral antiviral for treating COVID-19. The trial revealed a 50% reduction in hospitalization or death among patients receiving molnupiravir compared to placebo (7.3% vs 14.1%). No deaths occurred in the treatment group. Following these results, Merck plans to seek Emergency Use Authorization in the U.S. The study involved 775 patients, with full recruitment set for 1,550. Molnupiravir could be the first oral treatment for COVID-19, contingent on authorization.
Avoro Capital, a significant stakeholder in Acceleron Pharma (XLRN), has expressed concerns over the proposed acquisition by Merck (MRK) at $180 per share. This price represents a mere 38% premium, significantly lower than the average 89% for similar transactions since 2020. Avoro argues that the deal undervalues Acceleron, especially with promising data for its sotatercept candidate, currently in phase 3 trials and designated as a Breakthrough Therapy by the FDA. Avoro calls for a reassessment of the merger valuation due to the company's growing potential.