Bristol Myers Squibb Gains on Expanded FDA Approval for Breyanzi
The CAR-T cell therapy becomes the first of its kind approved for Marginal Zone Lymphoma, bolstering the drugmaker's oncology pipeline amid patent concerns.
Bristol Myers Squibb (NYSE: BMY) shares climbed nearly 2% on Tuesday after the U.S. Food and Drug Administration granted expanded approval for its cancer treatment Breyanzi, positioning it as a critical growth driver for the pharmaceutical giant.
The regulator approved the cell-based gene therapy for adults with relapsed or refractory marginal zone lymphoma (MZL), a slow-growing form of non-Hodgkin lymphoma. According to the company's announcement, this makes Breyanzi the first and only CAR T-cell therapy approved for this specific indication, marking a significant milestone for patients with limited treatment options.
Shares of Bristol Myers Squibb rose 1.94% to $51.95 in afternoon trading, boosting the company's market capitalization to over $103 billion. The approval adds to the positive momentum for Breyanzi, a cornerstone of the company's new product portfolio with annualized sales already surpassing $1 billion.
This latest approval marks the fifth distinct type of cancer Breyanzi is cleared to treat, solidifying its role in Bristol Myers Squibb’s strategy to navigate a challenging period of patent expirations for its blockbuster drugs, including the blood thinner Eliquis and cancer immunotherapy Opdivo. The company is increasingly reliant on its pipeline of newer drugs to offset anticipated revenue declines over the coming years.
"The expanded approval of Breyanzi for marginal zone lymphoma represents our commitment to developing innovative cancer treatments for patients with high unmet needs," a company spokesperson stated in the press release. The therapy, known chemically as lisocabtagene maraleucel, is a chimeric antigen receptor (CAR) T-cell therapy, a complex treatment that involves extracting a patient’s own T-cells, genetically modifying them to recognize and attack cancer cells, and then infusing them back into the patient.
The approval was based on data from the Phase 2 TRANSCEND FL study, which demonstrated the therapy's efficacy and safety in this patient population.
While the news provides a welcome boost, the broader sentiment from Wall Street remains cautious. Of the 27 analysts covering the stock, 20 maintain a "Hold" rating, according to market data. The consensus 12-month price target of $53.05 suggests limited upside from the current price, reflecting investor concerns about the long-term growth trajectory beyond the upcoming patent cliff.
Still, Breyanzi's expanding footprint is a key part of the bull case for the company. Bristol Myers Squibb is a major player in the competitive cell therapy market, vying for market share with rivals like Gilead Sciences' Yescarta and Johnson & Johnson's Carvykti. Each new indication approved for Breyanzi helps the company strengthen its position in the highly specialized and lucrative oncology market.
For investors, Bristol Myers Squibb presents a mixed picture. The company offers a robust dividend yield of over 5%, making it attractive for income-focused portfolios. However, its stock performance has lagged the broader market as it works to prove the commercial potential of its next generation of therapies. Tuesday's FDA decision is a tangible step forward, demonstrating progress in a pipeline that will be critical for the company's future success.