Latest news with #Breyanzi
Yahoo
30-06-2025
- Business
- Yahoo
BMY Loses 16.3% YTD: Should You Buy, Sell or Hold the Stock?
The first half of 2025 has been topsy-turvy for Bristol Myers BMY. Shares of this biotech giant have lost 16.3% year to date compared with the industry's decline of 2.7%. The stock has also underperformed the sector and the S&P 500 during this period. While a slew of positive regulatory updates boosted the stock, pipeline setbacks and generic competition weighed on the same. Image Source: Zacks Investment Research Even though the first-quarter performance was better than expected and BMY raised its annual revenue guidance, the stock has been on a downslide thereafter, likely reflecting broader market concerns and investors' skepticism about its growth prospects. Let us analyze Bristol Myers' fundamentals in such a scenario to make a prudent investment choice. Legacy Portfolio is being adversely impacted due to continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane, as well as the U.S. Medicare Part D redesign effect. Among these, blood thinner medicine Eliquis, for which BMY has a worldwide co-development and co-commercialization agreement with pharma giant Pfizer PFE, is the biggest contributor to the top line. Eliquis sales were down 4% in the first quarter due to the impact of Medicare Part D redesign in the United States. The company expects sales to steadily increase in the second half of 2025 due to the elimination of the coverage gap. BMY is relying on newer drugs, such as Opdualag, Reblozyl, and Breyanzi, to stabilize its revenue base as its legacy drugs face generic competition. Thalassemia drug Reblozyl, for which BMY has a collaboration agreement with Merck MRK, has delivered a stellar performance since its approval, driven by strong growth in the first and second-line treatment of myelodysplastic syndromes (MDS)- associated anemia. The drug is expected to make a significant contribution in the coming decade. Revenue growth for the leading immuno-oncology drug, Opdivo, has been solid, driven primarily by volume growth. The FDA had earlier granted approval to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. The European Commission ('EC') recently approved the perioperative regimen of neoadjuvant Opdivo and chemotherapy, followed by surgery and adjuvant Opdivo, for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The company recently received EC approval for the subcutaneous formulation of Opdivo across multiple solid tumor indications. Sales of CAR T cell therapy, Breyanzi, also continue to gain traction from the approval of new indications and expanded manufacturing capacity. Camzyos has also witnessed strong global uptake in obstructive HCM. BMY had earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults, under the brand name Cobenfy. The approval broadens BMY's portfolio. Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. This drug is expected to contribute meaningfully to BMY's top line in the coming years. BMY recently entered into a collaboration agreement with BioNTech BNTX. Both companies have entered into an agreement for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types. Developing bispecific antibodies that target two proteins, namely PD-1 and VEGF, has lately been one of the lucrative areas in cancer treatment. BNT327, a next-generation bispecific antibody candidate, targets PD-L1 and VEGF-A. BMY has experienced a few pipeline setbacks in recent months, which negatively impacted its share price. The late-stage ODYSSEY-HCM study, evaluating cardiovascular drug Camzyos for the treatment of adult patients with symptomatic New York Heart Association ('NYHA') class II-III non-obstructive hypertrophic cardiomyopathy, did not meet its dual primary endpoints. The top-line results from the phase III ARISE study on schizophrenia drug Cobenfy were also disappointing. The study is evaluating the efficacy and safety of the drug as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. Treatment with Cobenfy as an adjunctive demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale total score compared to placebo with an atypical antipsychotic at week six. However, this data did not reach the threshold for statistical significance for the primary endpoint. While BMY's strategy of acquiring companies with promising drugs and candidates is encouraging, it has resulted in substantial debt to finance these acquisitions. As of March 31, 2025, the company had cash and equivalents of $12.1 billion and a long-term debt of $46.1 billion. Going by the price/earnings ratio, BMY's shares currently trade at 7.24x forward earnings, lower than its mean of 8.54x and the large-cap pharma industry's 14.77x. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 EPS has moved down to $6.76 from $6.87 in the past 60 days, while that for 2026 has dipped to $6.04 from $6.07. Image Source: Zacks Investment Research Large biotech companies are generally considered safe havens for investors interested in this sector. Drugs like Reblozyl, Breyanzi, Camzyos and Opdualag have enabled BMY to stabilize its revenue base amid generic competition for its legacy drugs. Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline. However, generic competition is a major headwind for the company and the new drugs will take some time to offset this steep decline. The recent pipeline setbacks weigh on the stock. We recommend prospective investors to wait and watch for the time being. For investors already owning the stock, staying invested would be a prudent move. The company's attractive dividend yield (5.35%) is a strong reason for existing investors to stay invested. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Time of India
28-06-2025
- Health
- Time of India
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
Bengaluru: The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a safety program to protect patients from risky drugs, for currently approved CAR-T cell immunotherapies. REMS is required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns. The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurological toxicities, and medication guides. The cancer therapies include Bristol-Myers Squibb's Breyanzi and its partnered therapy Abecma with 2seventy bio , Johnson & Johnson's unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead Sciences' unit Kite's Tecartus and Yescarta. Bristol-Myers Squibb and Gilead Sciences did not immediately respond to Reuters' requests for comment. These are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma, the health regulator said. CAR-T treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body. In January 2024, the FDA asked several drugmakers to add a serious warning on the label of their cancer therapies that use CAR-T technology after reports of T-cell malignancies and adverse events identified since approval. The FDA earlier said the risk of T-cell malignancies including leukemia and lymphoma applies to all therapies in the class and can lead to hospitalization and death.
Globe and Mail
25-06-2025
- Business
- Globe and Mail
Will New Drugs Enable BMY to Offset the Impact of Generic Competition?
BMY depends on newer drugs like Opdualag, Reblozyl and Breyanzi to stabilize its revenue base as its legacy drugs face generic competition. Legacy Portfolio is adversely impacted due to continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane, as well as the U.S. Medicare Part D redesign effect. Sales of blood thinner medicine Eliquis were down 4% in the first quarter due to the impact of Medicare Part D redesign in the United States. In such a scenario, the performance of new drugs is key to BMY's growth. Thalassemia drug, Reblozyl, has put up a stellar performance, driven by strong growth in the first and second-line treatment of myelodysplastic syndromes (MDS)-associated anemia. The drug should contribute significantly in the coming decade. Revenue growth has been good for the leading immuno-oncology drug Opdivo, driven primarily by volume growth. Sales of CAR T cell therapy, Breyanzi, also continue to gain traction from the approval of new indications and expanded manufacturing capacity. Camzyos has also witnessed strong global uptake in obstructive HCM. BMY had earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults, under the brand name Cobenfy. The approval broadens BMY's portfolio. Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. This drug is expected to contribute meaningfully to BMY's top line in the coming years. Competition for BMY's Key Drugs Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space. The immuno-oncology space is dominated by pharma giant Merck 's MRK blockbuster drug Keytruda (pembrolizumab). Keytruda is approved for several types of cancer and alone accounts for around 50% of MRK's pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda. Pfizer PFE is one of the largest and most successful drugmakers in the field of oncology. It has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immunotherapies that treat a wide range of cancers, including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and lung cancer. Pfizer also has oncology biosimilars in its portfolio and markets six of them for cancer. Last month, Pfizer inked a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, outside China. BMY is also trying to develop bispecific antibodies. BMY's Price Performance, Valuation and Estimates Shares of Bristol Myers have lost 15% year to date compared with the industry 's decline of 3.4%. From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY's shares currently trade at 7.34x forward earnings, lower than its mean of 8.54x and the large-cap pharma industry's 14.79X. The Zacks Consensus Estimate for 2025 and 2026 earnings per share has moved south in the past 60 days. BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Only $1 to See All Zacks' Buys and Sells We're not kidding. Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent. Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators, and more, that closed 256 positions with double- and triple-digit gains in 2024 alone. See Stocks Now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report
Yahoo
29-05-2025
- Business
- Yahoo
Bristol Myers Loses 20.7% in 3 Months: Buy, Sell or Hold the Stock?
Shares of Bristol Myers BMY have lost 20.7% in the past three months compared with the industry's decline of 9.6%. The stock has also underperformed the sector and the S&P 500 during this period. While the year started on a positive note and BMY was faring well (outperforming the market), the stock has been on the downslide for the past couple of months. Image Source: Zacks Investment Research Even though the first-quarter performance was better-than-expected and BMY raised its annual revenue guidance, the stock declined thereafter, probably reflecting broader market concerns and investors' skepticism on BMY's growth prospects. Let us analyze Bristol Myers' fundamentals in such a scenario to help you deal with the stock going forward: Legacy Portfolio is being adversely impacted due to continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane, as well as the U.S. Medicare Part D redesign effect. Among these, blood thinner medicine Eliquis, for which BMY has a worldwide co-development and co-commercialization agreement with pharma giant Pfizer PFE, is the biggest contributor to the top line. Eliquis sales were down 4% in the first quarter due to the impact of Medicare Part D redesign in the United States. The company expects sales to steadily increase in the second half of 2025 due to the elimination of the coverage gap. BMY is depending on newer drugs like Opdualag, Reblozyl and Breyanzi to stabilize its revenue base as its legacy drugs face generic competition. Thalassemia drug Reblozyl, for which BMY has a collaboration agreement with Merck MRK, has put up a stellar performance since its approval, driven by strong growth in the first and second-line treatment of myelodysplastic syndromes (MDS)- associated anemia. The drug should contribute significantly in the coming decade. Revenue growth has been solid for the leading immuno-oncology drug Opdivo, driven primarily by volume growth. The FDA had earlier granted approval to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. The European Commission (EC) recently approved the perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The company recently received EC approval for the subcutaneous formulation of Opdivo across multiple solid tumor indications. Sales of CAR T cell therapy, Breyanzi, also continue to gain traction from the approval of new indications and expanded manufacturing capacity. Camzyos has also witnessed strong global uptake in obstructive HCM. BMY earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults, under the brand name Cobenfy. The approval broadens BMY's portfolio. Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. This drug is expected to contribute meaningfully to BMY's top line in the coming years. BMY has experienced a few pipeline setbacks in recent months, which negatively impacted its share price. The late-stage ODYSSEY-HCM study evaluating cardiovascular drug Camzyos for the treatment of adult patients with symptomatic New York Heart Association ('NYHA') class II-III non-obstructive hypertrophic cardiomyopathy did not meet its dual primary endpoints. The top-line results from the phase III ARISE study on schizophrenia drug Cobenfy were also disappointing. The study is evaluating the efficacy and safety of the drug as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. Treatment with Cobenfy as an adjunctive demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale total score compared to placebo with an atypical antipsychotic at week six. However, this data did not reach the threshold for statistical significance for the primary endpoint. While BMY's strategy of acquiring companies with promising drugs/candidates is encouraging, it has resulted in colossal debt to finance these acquisitions. As of March 31, 2025, the company had cash and equivalents of $12.1 billion and a long-term debt of $46.1 billion. Going by the price/earnings ratio, BMY's shares currently trade at 7.16x forward earnings, lower than its mean of 8.56x and the large-cap pharma industry's Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 EPS has moved up to $6.89 from $6.75 in the 60 days, while that for 2026 has remained unchanged at $6.08. Image Source: Zacks Investment Research Large biotech companies are generally considered safe havens for investors interested in this sector. Drugs like Reblozyl, Breyanzi, Camzyos and Opdualag have enabled BMY to stabilize its revenue base amid generic competition for its legacy drugs. Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline. However, generic competition is a major headwind for the company and the new drugs will take some time to offset this steep decline. The recent pipeline setbacks weigh on the stock. We recommend prospective investors to wait and watch for the time being. For investors already owning the stock, staying invested would be a prudent move. The company's attractive dividend yield (5.29%) is a strong reason for existing investors to stay invested. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-04-2025
- Business
- Yahoo
Bristol Myers Delivers Upbeat 2025 Forecast Despite China Tariffs Impact
Bristol Myers Squibb & Co (NYSE:BMY) reported first-quarter 2025 revenues of $11.20 billion, beating the consensus of $10.70 billion. Sales decreased 6% year-over-year, or 4% when adjusted for foreign exchange impacts. U.S. revenues of $7.9 billion decreased by 7%, and International revenues of $3.3 billion decreased by 2% or increased by 2% Ex-FX. Growth Portfolio revenues reached $5.6 billion, up 16% on a reported basis (18% Ex-FX), primarily driven by Opdivo, Breyanzi, Reblozyl, and Camzyos and reflected the strong early U.S. launch of Cobenfy. Also Read: Sales of the cancer drug Opdivo increased 9% to $2.265 billion. The arthritis drug Orencia generated sales of $770 million, down 4%. Sales of another cancer drug, Yervoy, increased 7% to $624 million. The anemia drug Reblozyl generated $478 million in quarter sales, up 35% from a year ago. Legacy Portfolio revenues of $5.6 billion declined 20% on a reported basis and Ex-FX due to the generic impact on Revlimid, Pomalyst, Sprycel, and Abraxane and the impacts from the U.S. Medicare Part D redesign. The company reported an adjusted EPS of $1.80, a turnaround from a loss of $4.40 a year ago, beating the consensus of $1.49. Gross margin decreased from 75.3% to 72.9% on a GAAP basis and from 75.5% to 73.1% on a non-GAAP basis, primarily due to product mix. Guidance: Bristol Myers Squibb has raised its fiscal year 2025 adjusted EPS from $6.55-$6.85 to $6.70-$7.00 compared to consensus of $6.74. On Thursday, the company stated that guidance revisions include the estimated impact of current tariffs on U.S. products shipped to China but do not account for potential pharmaceutical sector tariffs. The U.S. drug giant also raised the 2025 sales guidance from $45.50 billion to $45.80 billion—$46.80 billion, compared to the consensus of $45.76 billion. The increased guidance reflects the strong performance of the Growth Portfolio, better-than-expected Legacy Portfolio sales in the first quarter of 2025, and a favorable impact of approximately $500 million related to foreign exchange rates. Price Action: BMY stock is down 0.54% at $48.27 at the last check Thursday. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? BRISTOL-MYERS SQUIBB (BMY): Free Stock Analysis Report This article Bristol Myers Delivers Upbeat 2025 Forecast Despite China Tariffs Impact originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
