FDA Approves Bristol-Myers Squibb's Breyanzi as First-Ever CAR T Therapy for Rare Marginal Zone Lymphoma [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
price target on Bristol-Myers Squibb to $57 from $51, while maintaining a Neutral rating on the shares. Earlier on December 4, Bristol-Myers Squibb announced that the US FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory (R/R) marginal zone lymphoma/MZL. This approval specifically applies to patients who have already received at least two prior lines of systemic therapy. With this milestone, Breyanzi becomes the first and only CAR T cell therapy approved for this patient population, and it now holds the record as the only CD19-directed CAR T therapy approved for five distinct types of B-cell malignancies. The FDA's decision was based on results from the MZL cohort of the TRANSCEND FL study, which demonstrated deep and durable responses. In the primary efficacy analysis of 66 patients, Breyanzi achieved an overall response rate of 95.5%, with 62.1% of patients reaching a complete response. The treatment showed remarkable longevity; while
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BMY
Earnings
- 10/31/25 - Beat
BMY
Sec Filings
- 11/18/25 - Form 8-K
- 11/12/25 - Form CERT
- 11/10/25 - Form 8-A12B
- BMY's page on the SEC website