Merck & Co. (MRK) Announces that US FDA Approves ENFLONSIA™ For Preventing RSV Lower Respiratory Tract Disease

Merck & Co., Inc. (NYSE:MRK) is one of the 10 Best Value Stocks to Buy According to Billionaires. The company announced that the US FDA approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who were born during or entering their first RSV season. To provide a brief context, ENFLONSIA happens to be a preventive, long-acting monoclonal antibody (mAb) which has been designed to offer direct, rapid, and durable protection through 5 months, a typical RSV season, with the same 105 mg dose irrespective of weight. Merck & Co., Inc. (NYSE:MRK) further mentioned that the typical RSV season generally spans autumn to spring of the next year.

A close-up of a person’s hand holding a bottle of pharmaceuticals.

However, ENFLONSIA should not be administered to infants who have a history of serious hypersensitivity reactions, including anaphylaxis, to any of the components of ENFLONSIA. Merck & Co., Inc. (NYSE:MRK) added that the approval is basis the results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and full-term infants. Furthermore, the focus is to ensure the availability of ENFLONSIA in the US before the upcoming RSV season begins. This is to help in reducing the significant burden of the widespread seasonal infection on families and health care systems.

Artisan Partners, an investment management company, released its Q1 2025 investor letter. Here is what the fund said:

“Shares of Merck & Co., Inc. (NYSE:MRK), a health care solutions company, were down 9%. Operating results have been solid, with Q4 earnings beating expectations, but investors were more focused on the continued weak demand in China for Gardasil, a vaccine for human papillomavirus (HPV), and the company’s decision to pause vaccine shipments through at least mid-2025 to pare inventories. Though recent Gardasil setbacks have weighed on sentiment, the overarching issue for shareholders remains the success of Merck’s late-stage pipeline to replace sales that will be lost when blockbuster oncology drug Keytruda (50% of Q4sales) comes off patent in 2028. As shares sell cheaply at just 10X earnings, Merck seems to be getting little credit from investors for the 60+ programs it has in clinical development, despite having several solid and large new product opportunities. Additionally, the company’s strong balance sheet and robust free cash flow provide it multiple options for future partnerships and acquisitions, besides return of capital to shareholders via dividends and share repurchases.”

While we acknowledge the potential of MRK to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRK and that has 100x upside potential, check out our report about this cheapest AI stock.

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