Merck's BLA for RSV Antibody Clesrovimab Gets FDA Acceptance [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
its investigational prophylactic long-acting monoclonal antibody, clesrovimab (MK-1654), designed to protect infants from respiratory syncytial virus (RSV) disease entering their first RSV season. With the FDA accepting the BLA for review, a decision from the regulatory body is expected on June 10, 2025. Clesrovimab is likely to be available by July 2025 in the United States. If approved, clesrovimab can help address the burden of RSV disease in time for the 2025-26 RSV season. Year to date, shares of Merck have declined 8.3% against the industry's rise of 5.3%. Zacks Investment Research Image Source: Zacks Investment Research More on MRK's BLA for Clesrovimab The above BLA for clesrovimab was based on data from the pivotal phase IIb/III CLEVER (MK-1654-004) study and interim data from the ongoing phase III SMART (MK-1654-007) study. The placebo-controlled CLEVER study evaluated a single dose of clesrovimab administered to healthy preterm and full-term infants (birth
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