Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus – RSV – disease during their first RSV season. The FDA has set a Prescription Drug User Fee Act or target action date of June 10, 2025. The application is supported by results from the pivotal Phase 2b/3 CLEVER trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants, and interim results from the ongoing Phase 3 SMART trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease. Data from these trials were presented in October 2024. If approved, Merck anticipates that clesrovimab would be available for ordering by physicians and healthcare administrators by July 2025, with shipments to arrive in time for the 2025 RSV season.
Pick the best stocks and maximize your portfolio:
- Discover top-rated stocks from highly ranked analysts with Analyst Top Stocks!
- Easily identify outperforming stocks and invest smarter with Top Smart Score Stocks
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See the top stocks recommended by analysts >>
Read More on MRK:
- Merck to discontinue Phase 3 KeyVibe-003, KeyVibe-007 trials
- Merck announces approval of KEYTRUDA in China in combination with chemotherapy
- A Dissapointing Week for Dow Jones Industrial Average Puts It in the Red
- Merck announces CHMP opinion recommending conditional approval of Welireg
- AstraZeneca says 87.5% of Lynparza-treated patients alive at six years in trial
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
