Merck Secures FDA Nod for New RSV Antibody Enflonsia in Infants

Merck MRK announced FDA approval for its prophylactic long-acting monoclonal antibody, clesrovimab, for the prevention of RSV in newborns and infants born during or entering their first RSV season. The drug will be marketed under the brand name Enflonsia.The FDA’s decision came a day ahead of the previously announced target date of June 10, 2025. The approval is based on data from the pivotal phase IIb/III CLEVER study, which showed that treatment with a single dose of Enflonsia significantly reduced the incidence of RSV disease and hospitalization in healthy preterm and full-term infants.Merck plans to launch Enflonsia in the United States ahead of the upcoming 2025-26 RSV season and expects ordering for the shots to start next month. Per a Reuters article, Merck will price the antibody at $556 per dose.Merck’s Stock PerformanceYear to date, Merck’s shares have lost 20% compared with the industry’s 1% decline.Image Source: Zacks Investment ResearchOther RSV Antibodies/Vaccines Available in the MarketOnce commercially launched, Merck’s Enflonsia will face stiff competition from AstraZeneca AZN/Sanofi’s SNY RSV antibody Beyfortus, which was also approved for a similar indication in 2023. This AstraZeneca-Sanofi antibody achieved blockbuster status in its first full-year sales in 2024.Coincidentally, on the same day Enflonsia received approval, Sanofi revealed an aggressive effort to increase the supply of the AstraZeneca-partnered Beyfortus, including a plan to start shipping the antibody early in the third quarter of 2025.While there are multiple vaccines approved for preventing RSV in the United States, the only one approved for immunizing infants is Pfizer’s PFE Abrysvo. Unlike Beyfortus and Enflonsia, which can be administered directly, the Pfizer vaccine protects infants through maternal immunization. Most of the marketed RSV vaccines, including Pfizer’s, are approved for use in older adults aged 60 years and above.MRK’s Cholesterol Drug Meets Goal in Two Late-Stage StudiesIn a separate press release, Merck announced topline data from two phase III studies, CORALreef HeFH and CORALreef AddOn, which evaluated their investigational oral PCSK9 inhibitor, enlicitide decanoate, in adults with hyperlipidemia who had been previously treated with a statin.Both studies met their primary and key secondary endpoints, showing statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) after treatment with enlicitide. While the CORALreef HeFH evaluated the drug against a placebo, the CORALreef AddOn assessed the drug against other oral non-statin therapies.Merck & Co., Inc. Price  Merck & Co., Inc. price | Merck & Co., Inc. QuoteMRK’s Zacks RankMerck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Only $1 to See All Zacks' Buys and SellsWe're not kidding.Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks