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PRINCETON - The European Commission has granted approval to Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor, Bristol Myers Squibb (NYSE:BMY) announced Monday. This represents another milestone for the prominent pharmaceutical company, which according to InvestingPro data, maintains a "GREAT" financial health score and appears undervalued based on Fair Value estimates.
The approval is based on results from the MCL cohort of the TRANSCEND NHL 001 trial, where Breyanzi demonstrated an 82.7% overall response rate and a 71.6% complete response rate in third-line plus patients. The therapy showed sustained efficacy with 50.8% of patients still responding at 24 months. This development adds to BMY’s robust pharmaceutical portfolio, which generated $48 billion in revenue over the last twelve months with an impressive 73% gross profit margin.
Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, demonstrated a predictable safety profile consistent with previous trials. Cytokine release syndrome occurred in 61% of patients, with only 1% experiencing grade three or four severity. Neurologic toxicities occurred in 31% of patients, with 9% experiencing grade three or four events.
This marks the fourth approval for Breyanzi in Europe, where it is already approved for several types of large B-cell lymphomas and follicular lymphoma after multiple lines of therapy.
Mantle cell lymphoma is an aggressive, rare form of non-Hodgkin lymphoma, representing approximately 3% of NHL cases. The disease typically affects older adults, with an average diagnosis age in the mid-60s, and is more common in males than females.
The approval applies to all European Union member states and European Economic Area countries Iceland, Norway and Liechtenstein, according to the company’s press release statement. For investors tracking BMY’s progress, InvestingPro offers additional insights with 10 more ProTips and comprehensive analysis. BMY has maintained dividend payments for 55 consecutive years with a current yield of 5.36%, demonstrating long-term stability with relatively low price volatility (Beta: 0.31).
In other recent news, Bristol-Myers Squibb announced the pricing terms for its cash tender offers, accepting approximately $3.99 billion of Pool 1 Notes and $3.51 billion of Pool 2 Notes. The company adjusted the maximum aggregate purchase prices for these notes to accommodate all validly tendered notes by the early deadline. Meanwhile, BMO Capital reiterated its Market Perform rating with a $47 price target following Bristol-Myers Squibb’s analyst event in New York City, which outlined the company’s clinical opportunities and business strategy. BMO Capital also maintained its rating after the discontinuation of the LIBREXIA-ACS study, which was halted due to an independent review indicating it would not meet its primary endpoint. Cantor Fitzgerald reiterated its Neutral rating and $45 price target, citing positive developments in the company’s milvexian program. The firm noted that recent data supports the effectiveness of FXIa inhibition in reducing thrombosis while preserving hemostasis. These developments highlight Bristol-Myers Squibb’s ongoing strategic and clinical initiatives.
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