FDA Grants Priority Review To Merck's New Biologics License Application For V116, An Investigational, 21-Valent Pneumococcal Conjugate Vaccine
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The FDA has granted priority review to Merck's (MRK) new Biologics License Application for V116, an investigational 21-valent pneumococcal conjugate vaccine. The application is supported by results from multiple Phase 3 trials. If approved, V116 would be the first pneumococcal vaccine specifically designed for adults, covering 21 serotypes responsible for about 83% of invasive pneumococcal disease in individuals 65 and older, based on CDC data from 2018-2021.
December 19, 2023 | 11:56 am
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Merck's V116 vaccine for pneumococcal disease in adults has received FDA priority review, indicating a significant step towards approval and potential market leadership in adult pneumococcal vaccines.
The FDA's priority review of Merck's V116 vaccine suggests a positive outlook for approval, which could lead to increased revenue from a new product line. The vaccine's coverage of 21 serotypes, which are responsible for a significant portion of pneumococcal disease in older adults, positions it as a potential leader in this market segment. The news is likely to be viewed positively by investors, potentially leading to a short-term uptick in Merck's stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100