Gilead's Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of "Risks Of Secondary Cancer'
Portfolio Pulse from Vandana Singh
The FDA has announced a classwide black box warning for all CAR-T therapies due to the risk of secondary T-cell cancers. Gilead Sciences Inc's Tecartus was initially included but has since been removed from the list requiring the warning. The FDA is considering further regulatory action based on clinical testing and safety monitoring reports. Other CAR-T therapies from Bristol Myers Squibb, Novartis AG, and Johnson & Johnson/Legend Biotech Corporation are still required to carry the warning. Gilead's stock price has seen a slight decline following the news.
January 24, 2024 | 3:36 pm
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POSITIVE IMPACT
Gilead's Tecartus was removed from the FDA's list of CAR-T therapies requiring a new black box warning, potentially reducing concerns over its safety profile compared to competitors.
The removal of Tecartus from the list requiring a black box warning could be seen as a positive development for Gilead, potentially alleviating some safety concerns. However, the overall impact may be muted as the market reacts to the broader implications of the FDA's warning on the CAR-T therapy class. The slight decline in GILD's stock price suggests a cautious market response.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 90
NEGATIVE IMPACT
Bristol Myers Squibb's Breyanzi and Abecma are still required to carry the FDA's new black box warning, which could raise concerns about their safety profiles.
The requirement for Breyanzi and Abecma to carry the new black box warning could negatively impact the perception of their safety, potentially affecting their market competitiveness and short-term stock performance.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 70
NEGATIVE IMPACT
Johnson & Johnson, in partnership with Legend Biotech Corporation, will have to include the FDA's new black box warning on Carvykti, which may affect its competitive edge.
The FDA's requirement for Carvykti to carry the black box warning could lead to concerns about its safety profile, potentially affecting Johnson & Johnson's stock price and the product's market competitiveness.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 70
NEGATIVE IMPACT
Novartis AG's Kymriah is subject to the FDA's new black box warning, which may impact its safety perception and market position.
The inclusion of Kymriah in the list of therapies requiring a black box warning could lead to increased scrutiny and concern over its safety, possibly influencing Novartis' stock price in the short term.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 70