Merck said on Wednesday that its experimental oral HIV treatment met the main goal of a late-stage trial. ...

RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve) (MK-8591A-053). The success criterion for the primary efficacy hypothesis, as measured ...

Core Points - The European Commission has approved a new subcutaneous administration route and a new pharmaceutical form of KEYTRUDA, Merck's anti-PD-1 therapy [1] Company Summary - Merck, known as MSD outside the U.S. and Canada, will market the new formulation as KEYTRUDA SC in the European Union [1] - In the U.S., the product will be marketed as KEYTRUDA QLEX, which combines pembrolizumab and berahyaluronidase alfa-pmph [1]

Core Viewpoint - The pharmaceutical sector, particularly companies like Eli Lilly and Amgen, has seen significant stock price increases, driven by a shift in investor focus from AI-related stocks to more stable growth stocks in healthcare [2][3][4]. Group 1: Market Trends - The S&P 500 index reached a historical high on October 28, with Eli Lilly's stock rising by 25% and Amgen's by 17% [2]. - AI-related stocks, such as Oracle and Meta, have experienced significant declines, with Oracle down 22% and Meta down 20% [3]. - Investors are reallocating funds from large-cap tech stocks to defensive sectors like healthcare, which are perceived as offering stable growth [3][4]. Group 2: Policy Impact - Concerns over potential drug price reductions under the Trump administration had previously suppressed healthcare stocks, but these fears have begun to ease [4][5]. - A recent agreement between Pfizer and the U.S. government to control drug prices has shifted market perceptions, leading to a more favorable outlook for pharmaceutical companies [4][5]. Group 3: Company Performance - Eli Lilly reported strong earnings for Q3 2025, with its diabetes drug Mounjaro and obesity drug Zepbound exceeding market expectations [5]. - Other companies like Merck and Amgen also reported earnings surpassing market forecasts, contributing to rising stock prices [5]. - Analysts, including Morgan Stanley's Michael Wilson, have a positive outlook on healthcare stocks due to earnings growth, reduced policy uncertainty, and low valuations [5].

Group 1 - Nvidia's performance is positively influencing futures, with key indexes attempting to recover from recent losses [1] - Merck's stock experienced a significant increase due to a surprise win for its drug, sotatercept, in treating pulmonary hypertension [2] - CME Group and Marathon Petroleum are highlighted as strong stocks to monitor in the current market environment [1] Group 2 - Ligand Pharma's stock has surged by 88% this year, driven by its involvement in two major drugs [4] - The market is seeing a focus on stocks near buy points, including CrowdStrike and Valero, as oil refinery margins improve [4] - Merck is actively engaging in acquisitions, exemplified by its $9.2 billion deal for Cidara Therapeutics [4]

Core Insights - Merck & Co. has made a significant strategic move by acquiring Cidara Therapeutics for $9.2 billion, which has resulted in a more than 100% increase in Cidara's stock price, indicating a strong victory for its investors [3] - The market's stable reaction to the acquisition reflects Merck's confidence in its strategic planning, aiming to secure future revenue drivers and growth from a solid financial position [3][7] Strategic Imperative - Merck is addressing the upcoming 2028 patent expiration of its cancer therapy, Keytruda, by proactively diversifying its portfolio through science-led business development [4][5] - The acquisition of Cidara is part of a deliberate strategy to build long-term revenue drivers, showcasing Merck's commitment to sustainable growth [7] Financial Health - Merck's financial strength is highlighted by a trailing-twelve-month net income exceeding $17 billion and a debt-to-equity ratio of 0.69, allowing it to absorb the $9.2 billion acquisition without operational strain [6] - This acquisition follows Merck's recent purchase of Verona Pharma, indicating a consistent pattern of strategic investments in high-potential assets [6]

Core Insights - Merck & Co. Inc. has released topline results from the Phase 2 CADENCE study of Winrevair (sotatercept-csrk) for treating combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) [1][2] Group 1: Study Results - The CADENCE study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) from baseline at 24 weeks compared to placebo [2][3] - Winrevair showed an improvement in pulmonary vascular resistance, which is crucial for cardiac and pulmonary blood vessel function, potentially leading to better patient outcomes [3] Group 2: Safety and Future Plans - The safety profile observed in the CADENCE study was generally consistent with the known safety profile for Winrevair [2] - The company plans to present these results at a future scientific congress and intends to proceed with Phase 3 development [4] Group 3: Previous Studies and Current Performance - In June, Merck announced positive topline results from the Phase 3 HYPERION study evaluating Winrevair versus placebo [4] - Winrevair, when added to background therapy, demonstrated a statistically significant reduction in the risk of clinical worsening events compared to placebo [5] - As of the publication date, MRK stock is up 4.70% at $97.22 [6]

Company Performance - Home Depot shares fell 4% after the company reported disappointing third-quarter earnings and cut its full-year profit outlook [1] - Cloudflare shares declined 3% due to an outage affecting several prominent customers, including social media site X and ChatGPT [2] - Medtronic shares rose 4% after reporting better-than-expected fiscal 2026 second-quarter results and lifting its full-year outlook [4] - Merck stock advanced 4% following positive results from a Phase 2 trial of a heart drug [4] Market Trends - Major U.S. equities indexes, including the Dow Jones Industrial Average and Nasdaq, were down about 1%, with the S&P 500 falling 0.6% amid concerns about an AI bubble [1] - Oil and gold futures slipped, while the yield on the 10-year Treasury note edged lower [5] - Prices for most major cryptocurrencies were higher, with Strategy (MSTR) rebounding roughly 6% along with the price of Bitcoin [4]

Core Points - Merck has announced its first-quarter 2026 dividend, indicating a commitment to returning value to shareholders [1] Company Summary - The dividend announcement reflects Merck's financial health and strategic focus on shareholder returns [1] - The specific amount of the dividend and any changes compared to previous quarters were not detailed in the announcement [1] Industry Summary - The announcement of dividends is a common practice in the pharmaceutical industry, showcasing companies' profitability and stability [1] - Dividends can influence investor sentiment and stock performance within the sector [1]

Core Viewpoint - Merck (MRK.US) shares rose over 4% to $96.97 following the announcement of FDA approval for its pulmonary hypertension therapy, Winrevair, which met primary endpoints in patients with pulmonary hypertension [1] Group 1: Drug Approval and Efficacy - Winrevair has shown a significant reduction in pulmonary vascular resistance, achieving the primary endpoint of the Phase 2 CADENCE study with statistical and clinical significance [1] - The study evaluated the efficacy of the injection compared to a placebo in adult patients with pre-capillary and post-capillary pulmonary hypertension due to heart failure with preserved ejection fraction (HFpEF) [1] Group 2: Safety and Future Plans - The tolerability of Winrevair is consistent with established safety profiles, indicating a favorable safety profile for the drug [1] - The company plans to present the results at future medical conferences and continue advancing late-stage projects for the drug in CpcPH caused by HFpEF [1]