U.S. FDA Staff Reviewers Say "It Is Unclear Whether The Overall Benefit-Risk Assessment Is Favorable" For J&J's Carvykti
Portfolio Pulse from Benzinga Newsdesk
U.S. FDA staff reviewers have expressed uncertainty regarding the overall benefit-risk assessment of J&J's Carvykti, casting doubts on its approval prospects.
March 13, 2024 | 12:35 pm
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NEGATIVE IMPACT
FDA staff's uncertainty about Carvykti's benefit-risk may negatively impact J&J's stock in the short term due to potential approval delays or rejections.
The FDA's opinion is crucial for drug approvals. Negative feedback from FDA staff reviewers can lead to delays or rejections, affecting J&J's revenue prospects from Carvykti and potentially harming investor sentiment towards JNJ stock in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90