Focus On Bristol Myers, Gilead Sciences, Johnson & Johnson, Novartis: FDA To Issue Classwide Black Box Warning on CAR-T Therapies For Blood Cancer Treatment
Portfolio Pulse from Vandana Singh
The FDA is issuing a classwide black box warning for all approved CAR-T therapies due to the risk of secondary T-cell cancers. This affects products from Bristol Myers Squibb (BMY), Gilead Sciences' Kite Pharma (GILD), Johnson & Johnson (JNJ), Novartis (NVS), and Legend Biotech Corporation (LEGN). The warning will be included on the labels of six commercial CAR-T therapies. Despite this, the FDA maintains that the benefits of these products outweigh the risks. AstraZeneca (AZN) recently acquired Gracell Biotechnologies (GRCL) to enhance its cell therapy portfolio.
January 23, 2024 | 1:19 pm
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NEGATIVE IMPACT
Bristol Myers Squibb's CAR-T products Abecma and Breyanzi will now carry a black box warning due to secondary T-cell cancer risks.
The black box warning is the most severe alert and could potentially reduce the demand for BMY's CAR-T products, negatively impacting short-term stock performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Gilead Sciences' Kite Pharma's CAR-T products Yescarta and Tecartus will be labeled with a black box warning, indicating a risk of secondary T-cell cancers.
The imposition of a black box warning could lead to concerns among patients and healthcare providers, potentially affecting sales and GILD's stock price negatively in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Johnson & Johnson's CAR-T therapy Carvykti, developed with Legend Biotech, will include a black box warning due to the risk of T-cell malignancies.
The new FDA warning could lead to a decrease in the usage of Carvykti, potentially affecting JNJ's revenue from this product and negatively influencing the stock in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Legend Biotech's partnership with J&J on Carvykti will be affected by the FDA's black box warning for the risk of T-cell malignancies.
As a partner in the development of Carvykti, Legend Biotech may experience negative stock price movement due to the FDA's warning, which could impact the therapy's market perception and sales.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
Novartis' CAR-T therapy Kymriah will carry a black box warning for secondary T-cell cancer risks as mandated by the FDA.
The FDA's black box warning could potentially deter patients from using Kymriah, which may lead to a decline in sales and a negative impact on NVS's short-term stock performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
AstraZeneca's acquisition of Gracell Biotechnologies enhances its cell therapy portfolio, including a potential treatment for multiple myeloma.
The acquisition of Gracell Biotechnologies could be seen as a strategic move to strengthen AstraZeneca's position in the cell therapy market, potentially having a positive impact on AZN's stock in the short term.
CONFIDENCE 75
IMPORTANCE 60
RELEVANCE 70
POSITIVE IMPACT
Gracell Biotechnologies' acquisition by AstraZeneca at $2/share could benefit its stock due to the enhanced pipeline and resources.
The acquisition by AstraZeneca provides Gracell Biotechnologies with a significant boost in resources and market confidence, likely leading to a positive short-term impact on GRCL's stock price.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100