Eyes On Novartis, Gilead, Bristol Myers As FDA Weighs Risks Vs. Benefits Of Approved CAR T-Cell Therapies
Portfolio Pulse from Vandana Singh
The FDA is reviewing the risks of T-cell malignancies in patients treated with approved CAR T-cell therapies. Six therapies are affected, including products from Bristol Myers Squibb (BMY), 2seventy Bio (TSVT), Johnson & Johnson (JNJ), Novartis (NVS), and Gilead Sciences (GILD). The FDA acknowledges the benefits of these therapies outweigh the risks for approved uses. Bristol Myers Squibb and 2seventy Bio recently faced a delay in seeking expanded approval for Abecma. Analysts suggest varying levels of concern for different therapies, with Novartis' Kymriah potentially facing higher concerns.
November 29, 2023 | 1:30 pm
News sentiment analysis
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NEUTRAL IMPACT
Gilead Sciences' Yescarta and Tecartus are part of the FDA's safety review, but the company remains confident in the overall safety profile of these therapies.
Gilead's statement of confidence in the safety of its CAR T-cell therapies may mitigate negative investor sentiment, suggesting a neutral short-term impact on GILD's stock price.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 75
NEUTRAL IMPACT
Johnson & Johnson's CAR T-cell therapy Carvykti is included in the FDA's review of T-cell malignancy risks, but no specific concerns or delays have been reported.
Johnson & Johnson is a large, diversified company, and while the FDA's review includes Carvykti, the lack of specific concerns or delays suggests a neutral short-term impact on JNJ's stock price.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 70
NEGATIVE IMPACT
Bristol Myers Squibb's CAR T-cell therapies, Breyanzi and Abecma (in collaboration with 2seventy Bio), are under FDA review for potential T-cell malignancy risks. A delay in expanded approval for Abecma has occurred.
The FDA's review and the delay in approval for expanded use of Abecma could negatively impact investor sentiment and potentially delay future revenues from this treatment, leading to a short-term negative impact on BMY's stock price.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Novartis' Kymriah faces FDA review for T-cell malignancy risks, with analysts suggesting potentially higher concerns for this particular therapy.
The mention of potentially higher concerns for Novartis' Kymriah by analysts could lead to increased investor caution, potentially affecting NVS's stock price negatively in the short term.
CONFIDENCE 70
IMPORTANCE 75
RELEVANCE 80
NEGATIVE IMPACT
2seventy Bio, in collaboration with Bristol Myers Squibb, faces FDA scrutiny for its CAR T-cell therapy Abecma, and has experienced a delay in seeking expanded U.S. approval.
As a smaller company in collaboration with BMY, the FDA's concerns and the approval delay for Abecma could have a significant negative impact on 2seventy Bio's stock, given the importance of this therapy to its portfolio.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 85