Gilead Sciences Inc Says Will Work With The FDA On Next Steps Related To The Product Labeling Request; Not Aware Of Evidence To Date Establishing Treatment With Yescarta Or Tecartus Has Causal Role In Development Of Malignancies Of T-Cell Origin
Portfolio Pulse from Benzinga Newsdesk
Gilead Sciences Inc. has announced its intention to collaborate with the FDA regarding a product labeling request. The company has stated that there is no evidence to date that suggests a causal relationship between its treatments Yescarta or Tecartus and the development of T-cell origin malignancies.
January 23, 2024 | 4:28 pm
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NEUTRAL IMPACT
Gilead Sciences is set to collaborate with the FDA on product labeling, asserting no established link between Yescarta/Tecartus and T-cell malignancies.
Gilead's proactive approach to work with the FDA on product labeling could be seen as a positive step in addressing regulatory concerns. However, the mention of malignancies, even in the absence of evidence, could raise concerns among investors. The impact is likely to be neutral in the short term as the market digests the news and awaits further details.
CONFIDENCE 75
IMPORTANCE 60
RELEVANCE 80