Bristol Myers Squibb Receives FDA Approval for Breyanzi to Treat Relapsed Marginal Zone Lymphoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 hour ago
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Bristol Myers "announced that the FDA has granted approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor, CAR, T cell therapy, for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion*. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome, Neurologic Toxicities, and Secondary Hematological Malignancies." "The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb's deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment."
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Analyst Views on BMY
Wall Street analysts forecast BMY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BMY is 52.67 USD with a low forecast of 36.00 USD and a high forecast of 68.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
18 Analyst Rating
6 Buy
11 Hold
1 Sell
Moderate Buy
Current: 50.960
Low
36.00
Averages
52.67
High
68.00
Current: 50.960
Low
36.00
Averages
52.67
High
68.00
William Blair
Matthew Phipps
Market Perform
maintain
2025-12-03
New
Reason
William Blair
Matthew Phipps
Price Target
2025-12-03
New
maintain
Market Perform
Reason
William Blair analyst Matthew Phipps notes Bristol Myers today announced that its ADEPT-2 study evaluating Cobenfy in Alzheimer's disease psychosis will now read out by the end of 2026, versus prior timing for a readout by year-end 2025. The delay is due to the need for additional patient enrollment in the study given that irregularities were identified at several clinical trial sites, the analyst tells investors in a research note. Blair says that while a delay due to site irregularities typically raises concerns with investors, there is potentially a positive read-through in the Independent Data Monitoring Committee and Food and Drug Administration recommending continuation of the trial with more patients. This suggests positive trends are being observed, according to Blair. The firm thinks "any non-failure could be good news" given the selloff in Bristol Myers shares year-to-date. It has a Market Perform rating on the name. The stock in morning trading is up 5% to $50.76.
JPMorgan
analyst
Overweight
maintain
2025-12-03
New
Reason
JPMorgan
analyst
Price Target
2025-12-03
New
maintain
Overweight
Reason
After Bristol Myers announced that it is delaying the readout of the ADEPT-2 study of Cobenfy in Alzheimer's Psychosis as it adds more patients to the trial due to irregularities at some clinical trial sites, JPMorgan said the firm is "not completely surprised by this update" and sees it as an incremental positive. Expectations were low on ADEPT-2, the additional patient-adds enhances the chances of a successful study and this does not impact the timing of the FDA filing based on the remaining ADEPT study readouts, according to the analyst, who maintain an Overweight rating on the shares.
Leerink
David Risinger
Outperform
maintain
2025-12-03
New
Reason
Leerink
David Risinger
Price Target
2025-12-03
New
maintain
Outperform
Reason
Leerink analyst David Risinger notes that Bristol Myers announced that it will enroll additional patients in the ADEPT-2 study. The firm views it as positive news that the Data Monitoring Committee recommended enrolling additional patients in Cobenfy's ADEPT-2 trial in Alzheimer's disease psychosis patients. Recall that the company disclosed in early August that it was scrutinizing Cobenfy trial conduct, and Leerink and consensus feared the trial could fail. The firm keeps an Outperform rating on the shares.
Goldman Sachs
Neutral
maintain
$51 -> $57
2025-12-02
New
Reason
Goldman Sachs
Price Target
$51 -> $57
2025-12-02
New
maintain
Neutral
Reason
Goldman Sachs raised the firm's price target on Bristol Myers to $57 from $51 and keeps a Neutral rating on the shares.
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About BMY
Bristol-Myers Squibb Company is a global biopharmaceutical company. It is engaged in the discovery, development and delivery of transformational medicines for patients facing serious diseases in areas: oncology, hematology, immunology, cardiovascular, neuroscience and other areas. Its growth portfolio includes Opdivo (nivolumab), Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Yervoy (ipilimumab), Reblozyl (luspatercept-aamt), Opdualag (nivolumab and relatlimab-rmbw), Breyanzi (lisocabtagene maraleucel), Camzyos (mavacamten), Zeposia (ozanimod), Abecma (idecabtagene vicleucel), and Sotyktu (deucravacitinib). Its other growth products include Onureg, Inrebic, and Empliciti. Its legacy portfolio includes Eliquis (apixaban), Revlimid (lenalidomide), Pomalyst/Imnovid (pomalidomide), Sprycel (dasatinib), and Abraxane (paclitaxel albumin-bound particles for injectable suspension). Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells.
About the author
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Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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