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 successfully completed its cash tender offer for all outstanding shares of Acceleron Pharma Inc. (NASDAQ: XLRN) at a price of $180 per share. By the offer's expiration on November 19, 2021, approximately 63.3% of Acceleron’s shares were tendered. Following the merger, Acceleron will become a wholly owned subsidiary of Merck, and its stock will cease trading on Nasdaq. The acquisition aims to enhance Merck's portfolio and market presence in the biopharmaceutical space.
Merck (NYSE: MRK) announced an update on the Phase 2 IMAGINE-DR clinical trial, which evaluated the combination of MK-8507 and islatravir (ISL) for HIV-1 treatment. Due to significant decreases in total lymphocyte and CD4+ T-cell counts observed in participants receiving the highest doses of MK-8507, dosing has been halted on the recommendation of the external Data Monitoring Committee. Nevertheless, Merck remains committed to advancing islatravir across various settings, continuing other trials without MK-8507. The company previously reported positive results from the ILLUMINATE SWITCH A and B trials.
Merck (NYSE: MRK) announced FDA approval for KEYTRUDA, its anti-PD-1 therapy, as the first immunotherapy for adjuvant treatment in patients with intermediate-high or high-risk renal cell carcinoma (RCC) post-nephrectomy. This approval is based on the Phase 3 KEYNOTE-564 trial, showing a 32% reduction in disease recurrence or death risk compared to placebo (HR=0.68). While KEYTRUDA presents a promising new treatment option, it also comes with potential severe immune-mediated adverse reactions.
Avoro Capital Advisors, a major shareholder in Acceleron Pharma Inc. (XLRN), owning approximately 7%, expressed strong opposition to Merck's (MRK) tender offer of $180 per share. The firm criticized the transaction as poorly timed and undervaluing Acceleron, stating it believes significant shareholder value will emerge post results from the pivotal STELLAR phase 3 trial. Avoro emphasized its commitment to a standalone Acceleron, suggesting alternative financing methods if needed and urging other shareholders not to tender their shares, potentially indicating strong discontent among investors.
Merck (NYSE: MRK) has announced the expiration of the waiting period under the Hart-Scott-Rodino Act concerning its acquisition of Acceleron Pharma Inc. (NASDAQ: XLRN). The cash tender offer for Acceleron's outstanding shares at $180 each has been extended to November 19, 2021. Approximately 11,980,722 shares, or 19.6% of Acceleron’s outstanding shares, were tendered by November 16, 2021. The acquisition is anticipated to close in Q4 2021, pending fulfillment of other conditions outlined in the previously filed SEC tender offer statement.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced new Phase 3 data for molnupiravir, an oral COVID-19 antiviral. This data will be presented at the ASTMH 2021 Annual Meeting from Nov. 17-21, including interim results from the MOVe-OUT trial. The trial showed positive efficacy, reducing hospitalization or death risk by approximately 50% in high-risk patients. Merck has produced 10 million courses of molnupiravir by the end of 2021 and plans for 20 million in 2022, focusing on global access.
Merck (NYSE: MRK) has launched the VICTOR trial, a pivotal Phase 3 study of VERQUVO (vericiguat) aimed at treating adults with chronic heart failure and reduced ejection fraction. This randomized, placebo-controlled trial will enroll approximately 6,000 participants globally, focusing on patients with an ejection fraction of 40% or less who have not experienced a recent worsening heart failure event. The primary efficacy endpoint is the time to cardiovascular death or heart failure hospitalization. The trial is expected to conclude in 39 months and follows the successful VICTORIA study.
Organon reported Q3 2021 revenue of $1,600 million, down 1% from Q3 2020. Net income was $323 million or $1.27 per diluted share, a 42% decline year-over-year. Adjusted EBITDA fell 15% to $636 million, with a margin of 39.8%. The company affirmed its financial guidance and announced a quarterly dividend of $0.28 per share. Notably, Women’s Health revenue dropped 10%, while Biosimilars rose 41%. Organon is actively expanding through acquisitions and maintaining strong cash flow with $1,008 million in cash, despite high debt levels.
Organon (NYSE: OGN) has announced its acquisition of Forendo Pharma, a clinical-stage company focusing on innovative treatments for women’s health. The deal includes a $75 million upfront payment, with additional potential payments totaling up to $954 million based on milestones. Forendo's lead candidate, FOR-6219, is a novel oral HSD17B1 inhibitor for treating endometriosis and is entering Phase 2 clinical trials. This acquisition aligns with Organon’s commitment to addressing significant unmet needs in women's health, including conditions like endometriosis and polycystic ovarian syndrome (PCOS).
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced an agreement with the Japanese government to purchase approximately 1.6 million courses of molnupiravir, an oral antiviral for COVID-19, pending regulatory approval. The deal is valued at around $1.2 billion. Merck anticipates producing 10 million treatment courses by the end of 2021 and at least 20 million in 2022. The company has initiated various global supply agreements and aims to broaden access to molnupiravir through tiered pricing and licensing for generic versions.