Merck & Co., Inc. (NYSE:MRK) is one of the best affordable healthcare stocks to buy now. Jefferies analyst Tycho Peterson reaffirmed a Buy rating on Merck & Co., Inc. (NYSE:MRK) on December 19 and set a $139.00 price target. Why Merck & Co (MRK) Continues to Rank Among the Most Profitable Dividend Stocks The same day, Merck & Co., Inc. (NYSE:MRK) announced a historic agreement with the Trump administration to ensure the affordability and accessibility of its medicines for Americans. The agreement allows ...

Core Insights - The FDA is set to fast-track reviews for two Merck drugs, enlicitide decanoate and sacituzumab tirumotecan, under the CNPV program, which aims to expedite regulatory decisions for critical medicines [1][5] - If approved, these drugs will be the 17th and 18th to enter the CNPV program, highlighting their potential significance in the market [2] - Merck's enlicitide decanoate has shown promising results in the Phase 3 CORALreef Lipids trial, achieving significant reductions in LDL-C compared to placebo [4] Group 1 - The FDA's CNPV program was announced in June, allowing for a significant reduction in review time from approximately 10-12 months to 1-2 months post-application submission [5] - Merck plans to submit its application for enlicitide in April and for sac-TMT in October or November of the following year [5] - The CNPV program has previously been utilized for notable drugs, including Eli Lilly's weight-loss pill, indicating its importance in the pharmaceutical landscape [6] Group 2 - Merck's stock price increased by 0.59% to $99.76 at the time of publication, reflecting positive market sentiment regarding the potential approval of these drugs [7]

Core Insights - Merck & Co., Inc. (NYSE:MRK) is recognized for its potential as a strong investment, particularly highlighted in the context of Roth IRA stocks [1][4]. Group 1: Clinical Trial Results - Merck reported positive topline results from its Phase 3 CORALreef Lipids trial for enlicitide decanoate, an investigational oral PCSK9 inhibitor for hypercholesterolemia, on September 2, 2025 [2]. - The study met all endpoints, showing significant reductions in LDL-C, non-HDL-C, ApoB, and Lp(a) compared to placebo at Week 24 [3]. - Safety outcomes were favorable, with low discontinuation rates and no significant differences in adverse events between treatment groups, reinforcing the drug's promise as the first oral macrocyclic peptide PCSK9 inhibitor [3]. Group 2: Company Overview - Merck & Co., Inc. is a global biopharmaceutical company focused on developing innovative medicines, vaccines, and health solutions aimed at saving and improving lives worldwide [4].

Core Insights - Merck (MRK) is experiencing growth driven by new products and a robust pipeline, particularly in oncology, vaccines, and infectious diseases [1][2] - The company's phase III pipeline has nearly tripled since 2021, positioning it to launch around 20 new vaccines and drugs in the coming years, many of which have blockbuster potential [2][10] Pipeline and Product Development - Promising late-stage candidates include enlicitide decanoate/MK-0616 for hypercholesterolemia, tulisokibart for ulcerative colitis, and bomedemstat for blood disorders [3][6] - The CORALreef Lipids study demonstrated that enlicitide decanoate significantly reduced LDL cholesterol levels compared to placebo, meeting all primary and key secondary endpoints [4][5][10] - If approved, enlicitide decanoate could be the first oral PCSK9 inhibitor, potentially transforming LDL management [6][10] Competitive Landscape - The cholesterol management market is competitive, with existing PCSK9 inhibitors like Amgen's Repatha and Regeneron's Praluent, as well as AstraZeneca's developing oral PCSK9 inhibitor, AZD0780 [7][8] Long-Term Growth Strategy - Merck is focusing on new drug approvals to sustain growth, especially as its blockbuster Keytruda faces loss of exclusivity in 2028 [11] - New products like the 21-valent pneumococcal conjugate vaccine Capvaxive and pulmonary arterial hypertension drug Winrevair are expected to generate significant revenues [11][12] Financial Performance and Valuation - Year-to-date, Merck's shares have decreased by 14.1%, contrasting with a 0.5% decline in the industry [13] - Merck's price/earnings ratio is currently at 9.12, lower than the industry average of 14.78, indicating attractive valuation [14] - The Zacks Consensus Estimate for 2025 earnings has slightly increased, while the estimate for 2026 has decreased [15]

Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]