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RAHWAY, N.J. - The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has recommended Merck’s (NYSE:MRK) ENFLONSIA as a preventive option against respiratory syncytial virus (RSV) in infants younger than 8 months born during or entering their first RSV season. The pharmaceutical giant, with a market capitalization of $199 billion and an impressive 77% gross profit margin, continues to strengthen its position in the healthcare sector. According to InvestingPro analysis, Merck maintains a "GREAT" financial health score, suggesting strong potential for this new product launch.
The committee also voted to include ENFLONSIA in the Vaccines for Children Program, which aims to improve access to this preventive treatment.
ENFLONSIA is a long-acting monoclonal antibody designed to provide protection through five months with a standardized dose regardless of an infant’s weight. The U.S. Food and Drug Administration approved the treatment earlier this month based on data from Phase 2b/3 CLEVER and Phase 3 SMART clinical trials.
According to the CDC, RSV hospitalizes two to three out of every 100 infants under 6 months annually, making it the leading cause of infant hospitalization in the United States.
Merck (NYSE:MRK) plans to make ENFLONSIA available for ordering in July 2025, with deliveries scheduled before the start of the 2025-2026 RSV season, which typically runs from fall through spring.
The ACIP recommendation is provisional until reviewed and finalized by the CDC Director or Health and Human Services Secretary.
The most common adverse reactions reported in clinical trials included injection-site erythema (3.8%), injection-site swelling (2.7%), and rash (2.3%).
This article is based on a press release statement from Merck.
In other recent news, Merck announced positive topline results from its Phase 3 HYPERION study evaluating Winrevair for pulmonary arterial hypertension (PAH). The study met its primary endpoint by showing a significant reduction in the risk of clinical worsening events compared to placebo. Merck is in discussions with regulators to incorporate this data into the Winrevair label, which could impact payer and physician decisions. Additionally, the U.S. Food and Drug Administration approved Merck’s Keytruda for treating locally advanced head and neck squamous cell carcinoma, based on the Phase 3 KEYNOTE-689 trial results. This approval marks Keytruda as the first perioperative anti-PD-1 treatment for this patient group. In the veterinary sector, Merck Animal Health received a positive opinion from the European Medicines Agency for its canine dermatitis drug, Numelvi. If approved, Numelvi will be the first second-generation JAK inhibitor for treating allergic dermatitis in dogs. Furthermore, Merck has initiated a Phase 3 clinical trial for its dengue vaccine candidate, enrolling around 12,000 children to assess its effectiveness against all four serotypes of the virus. Morgan Stanley maintained an Equalweight rating on Merck, with a price target of $99.00, reflecting confidence in the company’s cardiometabolic franchise.
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