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 has received antitrust clearance for its acquisition of Acceleron Pharma Inc. from competition authorities in Germany and Austria. The acquisition involves a cash tender offer of $180 per share, as announced on October 12, 2021. This step fulfills one of the necessary conditions for the tender offer's completion. The tender offer is set to expire on November 18, 2021, unless extended. The acquisition is anticipated to close in Q4 2021, pending other conditions detailed in the SEC filings.
Acceleron Pharma reported Q3 2021 revenue of $34.2 million, including $32.0 million in royalty revenue from REBLOZYL, up from $25.6 million last quarter. Merck agreed to acquire Acceleron for $180 per share, valuing the deal at approximately $11.5 billion, expected to close in Q4. The company has several ongoing Phase 3 trials for its therapies, including sotatercept for pulmonary hypertension and ACE-1334 for systemic sclerosis-associated lung disease. Cash reserves stand at $652.5 million.
The U.K. Medicines and Healthcare Products Regulatory Agency has authorized molnupiravir, an oral antiviral, for treating mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 test and risk factors for severe illness. This marks a significant step as it is the first oral antiviral to receive such authorization. Merck (NYSE: MRK) is working to gain additional approvals globally, with applications submitted to the FDA and the European Medicines Agency. The authorization is based on positive results from the Phase 3 MOVe-OUT trial, indicating a 50% reduction in hospitalization or death risk.
Merck announced significant findings for KEYTRUDA at the SMR 2021 Congress, showcasing its effectiveness in treating melanoma. The exploratory 7-year follow-up data from KEYNOTE-006 showed a median overall survival of 32.7 months for KEYTRUDA versus 15.9 months for ipilimumab. The 7-year survival rates were 37.8% vs. 25.3%, respectively. In the KEYNOTE-716 trial, KEYTRUDA demonstrated a 39% reduction in the risk of disease recurrence compared to placebo in patients with resected stage IIB/IIC melanoma. Safety profiles were consistent across studies, with no new safety signals identified.
Merck (NYSE: MRK) has withdrawn its Premerger Notification under the HSR Act concerning its acquisition of Acceleron Pharma Inc. (NASDAQ: XLRN), initially filed on October 14, 2021. This decision allows more time for FTC review, with a refiling expected around November 1, 2021. The tender offer for Acceleron shares at $180 per share is extended until November 18, 2021. As of October 28, 2021, approximately 8.4 million shares have been tendered, representing 13.7% of Acceleron's outstanding shares. The acquisition is anticipated to close in Q4 2021, pending regulatory approvals.
Avoro Capital Advisors, holding approximately 7% of Acceleron Pharma, opposes Merck's proposed acquisition of Acceleron at $180 per share, deeming it undervalued. Avoro believes Acceleron has significant potential as a standalone entity, especially with upcoming Phase 3 STELLAR trial results expected by end of 2022 that could enhance share price. The letter emphasizes monetizing existing royalties from Reblozyl and exploring better strategic alternatives to maximize shareholder value, criticizing the Board's decision-making process and urging fellow shareholders to reject the tender offer.
Organon (NYSE: OGN) will release its third quarter 2021 financial results on November 11, 2021, before a webcast and conference call at 8:30 a.m. ET. Interested parties can access the live call via the Organon website, with a replay available two hours post-event. Institutional investors must register in advance to participate. Formed from a spin-off of Merck (NYSE: MRK), Organon focuses on women's health with over 60 medicines and products, pursuing collaboration with biopharmaceutical innovators.
Merck (MRK) reported strong third-quarter 2021 sales of $13.2 billion, a 20% increase year-over-year. Key drivers included KEYTRUDA sales, up 22% to $4.5 billion, and GARDASIL, with sales surging 68% to $2 billion. The company achieved a GAAP EPS of $1.80 and non-GAAP EPS of $1.75. Merck raised its 2021 revenue outlook to $47.4-$47.9 billion, reflecting a 14-15% growth. The acquisition of Acceleron Pharma aims to enhance Merck's cardiovascular pipeline. Multiple regulatory approvals for cancer treatments and COVID-19 antiviral molnupiravir highlight ongoing innovation.
Merck (NYSE: MRK) announced Week 144 data from its Phase 2b study on islatravir combined with doravirine for HIV-1 treatment. The study found that this combination maintained viral suppression in treatment-naïve adults, showing 72.2% achieved HIV-1 RNA levels 50 copies/mL, comparable to 77.4% in the control group. The safety profile was similar across groups, with key adverse events reported at manageable rates. Merck is advancing its ILLUMINATE Phase 3 program, aiming for broader applications of islatravir, which is part of their commitment to addressing HIV globally.
Merck has announced a voluntary licensing agreement with the Medicines Patent Pool (MPP) for its investigational oral COVID-19 antiviral, molnupiravir. The agreement allows MPP to sublicense molnupiravir production in 105 low- and middle-income countries, ensuring affordable access without royalties for Merck, Ridgeback Biotherapeutics, and Emory University as long as COVID-19 is a public health emergency. Merck aims to enhance global healthcare access through this initiative, marking MPP's first voluntary license for a COVID-19 treatment.