Merus Receives FDA extension of PDUFA for zenocutuzumab
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Merus N.V. announced that the FDA has extended the PDUFA goal date for its zenocutuzumab Biologics License Application, which is under priority review.
November 05, 2024 | 12:30 pm
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Merus N.V. has received an extension from the FDA for the PDUFA goal date of its zenocutuzumab BLA, which is under priority review. This extension may delay the potential approval and market entry of zenocutuzumab.
The FDA's extension of the PDUFA date suggests a delay in the approval process for zenocutuzumab, which could impact Merus's timeline for bringing the drug to market. This may lead to short-term negative sentiment among investors due to the uncertainty and potential delay in revenue generation.
CONFIDENCE 90
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RELEVANCE 100