Latest news with #Yervoy
Yahoo
6 days ago
- Business
- Yahoo
EXEL Reports Superior Efficacy Data From Kidney Cancer Study Cohort
Exelixis EXEL announced encouraging results from an expansion cohort of the early to mid-stage study of its next-generation oral TKI, zanzalintinib, in combination with either Bristol Myers' BMY Opdivo (nivolumab) or a fixed-dose combination of nivolumab and relatlimab (Opdualag) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The phase Ib/II STELLAR-002 study is evaluating the candidate's safety and efficacy as a monotherapy or in combination with Opdivo, Opdualag, or the Opdivo/Yervoy combo in patients with advanced solid tumors. According to data from the expansion cohort of Exelixis' STELLAR-002 study, the combination of zanzalintinib with Bristol Myers' Opdivo demonstrated an objective response rate (ORR) of 63%, while the combination with Opdualag showed an ORR of 40%. Both treatment arms achieved a disease control rate of 90%. At a median follow-up of 20.1 months for the Opdivo arm and 15.9 months for the Opdualag arm, the 12-month duration of response was 73.4% and 74.1%, respectively. Median progression-free survival was reported as 18.5 months and 13 months for the Opdivo and Opdualag combinations, respectively. EXEL shares have risen 28.7% year to date against the industry's decline of 5.6%. Image Source: Zacks Investment Research The zanzalintinib/Opdivo combo has the potential to address the unmet medical need for RCC treatments. Based on the encouraging high rate of durable responses and long progression-free survival data observed, coupled with the lack of other effective therapies in the market, the company plans to further evaluate the regimen. Treatment-emergent adverse events (TEAEs) occurred in all patients, with common grade 3/4 events, including hypertension, diarrhea and liver enzyme elevations in both treatment arms. Two grade 5 TEAEs were reported per arm (none treatment-related). Study drug discontinuation due to TEAEs was observed in 8% and 20% of patients in the Opdivo and Opdualag combination arms, respectively. Exelixis shared additional data from several cohorts in the phase Ib/II STELLAR-002 study, evaluating different dose combinations of zanzalintinib with Bristol Myers' Opdivo or Opdualag in patients with advanced solid tumors. Colorectal and prostate cancers were most common among patients receiving zanzalintinib with Opdivo, while RCC was the most frequent tumor type in the Opdualag cohorts. The combination therapies showed a manageable safety profile consistent with the individual agents. Early safety, efficacy, and pharmacokinetic data supported the selection of the 100 mg zanzalintinib dose for the ongoing expansion cohorts. Please note that Bristol Myers' Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the European Union. BMY's Opdualag is also currently approved in the United States and the EU for treating unresectable or metastatic melanoma. Exelixis, Inc. price-consensus-chart | Exelixis, Inc. Quote Exelixis currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Bayer BAYRY and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 41.8%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. In the past 60 days, estimates for Amarin's loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 13.3%. AMRN's earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%. 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 Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
16-05-2025
- Business
- Yahoo
BlueSphere Bio Appoints Alan Korman, Ph.D. as Chief Scientific Officer
Seasoned executive brings more than three decades of immunotherapy and drug discovery experience PITTSBURGH, May 16, 2025 (GLOBE NEWSWIRE) -- BlueSphere Bio, a clinical stage drug development company focused on novel T cell based therapies, today announced the appointment of Alan Korman, Ph.D., as Chief Scientific Officer. Dr. Korman brings extensive immunotherapy drug discovery and research experience, and has served on the BlueSphere Board of Directors since 2020. 'We are honored to have Dr. Korman as our new Chief Scientific Officer. His leadership and esteemed track record pioneering transformational therapies will be instrumental in advancing our pipeline with an increased focus on TCR-based modalities, including bispecifics,' said Keir Loiacono, Esq., Chief Executive Officer of BlueSphere Bio. 'Alan's deep expertise in biologics and drug discovery will further position BlueSphere to ensure we are pursuing novel tumor antigens deployable in next generation treatment modalities. This will include overseeing our current discovery program in dark matter antigens.' 'I am excited to evolve my role and further contribute to BlueSphere's future. As an original Board member, having observed BSB's early evolution and entry into clincial development, I am eager to lead its highly capable research team as we build a differentiated pipeline of clinically and commercially relevant assets,' noted Dr. Korman. 'As a Board member, I have interacted closely with the Executive Team at BlueSphere and look forward to working alongside them.' Dr. Korman brings more than 30 years of immunology and drug discovery experience to BlueSphere. Prior to joining BlueSphere, he served as the Senior Vice President of Human Immunology at Vir Biotechnology. Before that, Dr. Korman was the Vice President of Immuno-Oncology Discovery at Bristol-Myers Squibb (BMS). Earlier, he worked at Medarex in roles of increasing responsibility through to Vice President of Discovery Research. While at BMS and Medarex, Dr. Korman led the discovery of the immune checkpoint blockade approaches to cancer immune therapy. He directed the preclinical development of Yervoy and Opdivo and their combination, which significantly impacted countless cancer patients' lives and meaningfully advanced the field of cancer therapy research. Dr. Korman began his career in the pharmaceutical industry at Supragen and NeXstar Pharmaceuticals, where he served as Director of Immunology. Dr. Korman received his Ph.D. in Cellular and Developmental Biology from Harvard University, A.M. in Biology from Harvard University and A.B. in Biology from Brandeis University. Following the completion of his education, he was a Fellow at the Whitehead Institute at the Massachusetts Institute of Technology. In addition, Dr. Korman holds more than 30 patents and most notably, played an instrumental role in the discovery of the first anti-CTLA-4 checkpoint inhibitor. About BlueSphere BioBlueSphere Bio is a clinical stage drug development company. The Company is the first translational sciences stand-alone company formed by UPMC Enterprises, the innovation, commercialization, and venture capital arm of the Pittsburgh-based health system. BlueSphere's initial clinical programs focus on deploying TCR T-cell therapies in high-risk leukemias. The Company's first clinical asset, BSB-1001, is currently enrolling patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or myeloid dysplastic syndrome (MDS). BSB-1001 is a TCR T cell therapy targeting the minor histocompatibility antigen-1 (HA-1) and is the first clinical candidate in the Company's TCX-101 clinical program. Under the TCX-101 clinical program, BSB-1001 is dosed simultaneously with allogeneic hematopoietic stem cell transplant. The Company has also discovered and nominated three additional miHA targeting TCRs for clinical development, all for use in the same clinical setting as BSB-1001. These additional miHA candidates will become part of the TCX-101 Program as a panel that positions the Company with best-in-class HLA coverage in these hematologic indications. In addition to TCX-101, BlueSphere has further broadened its AML therapy pipeline to address an additional subset of patients by discovering and nominating a lead TCR reactive against mutant NPM-1, a driver mutation in AML, for the TCX-102 program. The TCX-102 program will be autologous and not given in combination with stem cell transplant. An IND is expected in the second quarter of 2025. BlueSphere was founded upon a proprietary TCR discovery platform that can be used in various clinical settings to discover TCRs for targeting intracellular antigens in either TCR-based cell therapy or in antibody-like molecules, such as bi-specific T cell engagers. While the Company's initial focus is oncology, the platform could be deployed in other therapeutic areas. Company Contact: Kim JaffeChief Business Officer+1-609-306-7042kjaffe@ 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
Reuters
24-04-2025
- Business
- Reuters
Bristol Myers posts better-than-expected quarterly revenue on strong cancer drug sales
April 24 (Reuters) - Bristol Myers Squibb (BMY.N), opens new tab reported better-than-expected first-quarter revenue on Thursday and raised its full-year forecast due to growth from its portfolio of drugs that spur a patient's own immune system to fight cancer. The company's shares have dropped more than 20% over the past month as investor concerns about U.S. President Donald Trump's tariff threats have roiled the markets. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Chief Financial Officer David Elkins said in an interview that the company's global manufacturing footprint puts it in a good position to deal with whatever tariffs may come. "We have a really resilient supply chain, and we have manufacturing globally," Elkins said. "That gives us a lot of flexibility to move our manufacturing as appropriate." The U.S. started a probe into the pharmaceutical sector earlier this month as part of a bid to impose tariffs on the industry. Elkins said it was too early to understand the impact of potential tariffs targeting the pharmaceutical industry, and that Bristol Myers' forecast did not include any assumptions related to them. Revenue in the quarter fell less sharply than Wall Street analysts had forecast, coming in at $11.2 billion for the quarter, down from $11.9 billion a year earlier. Analysts had expected revenue of around $10.6 billion, according to LSEG data. Sales of the company's cancer immunotherapy Opdivo were $2.3 billion in the quarter, compared with Wall Street forecasts of just under $2 billion. Sales of its older immunotherapy, Yervoy, were $624 million in the quarter, more than $100 million higher than analysts' forecasts. The U.S. drugmaker also benefited as sales of some of its older or off-patent drugs like blood thinner Eliquis, which it shares with Pfizer (PFE.N), opens new tab, and blood cancer drug Revlimid fell less than expected. The company posted earnings of $2.5 billion, or $1.20 a share, roughly in line with Wall Street expectations. It raised its full-year forecast for revenue to a range of $45.8 billion to $46.8 billion from its previous forecast of $45.5 billion. It now expects full-year earnings in the range of $6.70 to $7 a share.
Yahoo
24-04-2025
- Business
- Yahoo
Bristol Myers posts better-than-expected quarterly revenue on strong cancer drug sales
By Michael Erman (Reuters) -Bristol Myers Squibb reported better-than-expected first-quarter revenue on Thursday and raised its full-year forecast due to growth from its portfolio of drugs that spur a patient's own immune system to fight cancer. The company's shares have dropped more than 20% over the past month as investor concerns about U.S. President Donald Trump's tariff threats have roiled the markets. Chief Financial Officer David Elkins said in an interview that the company's global manufacturing footprint puts it in a good position to deal with whatever tariffs may come. "We have a really resilient supply chain, and we have manufacturing globally," Elkins said. "That gives us a lot of flexibility to move our manufacturing as appropriate." The U.S. started a probe into the pharmaceutical sector earlier this month as part of a bid to impose tariffs on the industry. Elkins said it was too early to understand the impact of potential tariffs targeting the pharmaceutical industry, and that Bristol Myers' forecast did not include any assumptions related to them. Revenue in the quarter fell less sharply than Wall Street analysts had forecast, coming in at $11.2 billion for the quarter, down from $11.9 billion a year earlier. Analysts had expected revenue of around $10.6 billion, according to LSEG data. Sales of the company's cancer immunotherapy Opdivo were $2.3 billion in the quarter, compared with Wall Street forecasts of just under $2 billion. Sales of its older immunotherapy, Yervoy, were $624 million in the quarter, more than $100 million higher than analysts' forecasts. The U.S. drugmaker also benefited as sales of some of its older or off-patent drugs like blood thinner Eliquis, which it shares with Pfizer, and blood cancer drug Revlimid fell less than expected. The company posted earnings of $2.5 billion, or $1.20 a share, roughly in line with Wall Street expectations. It raised its full-year forecast for revenue to a range of $45.8 billion to $46.8 billion from its previous forecast of $45.5 billion. It now expects full-year earnings in the range of $6.70 to $7 a share.
Yahoo
09-04-2025
- Business
- Yahoo
Bristol-Myers Squibb (NYSE:BMY) Achieves Early FDA Approval for Opdivo Plus Yervoy Therapy
Bristol-Myers Squibb recently received FDA approval for the combination therapy of Opdivo and Yervoy, significantly enhancing its immunotherapy portfolio. Despite this positive development, the company's share price fell by 7% over the last quarter. This decline occurred in the backdrop of a broader market downturn, where major indices, like the S&P 500, experienced a 12% drop due to escalating trade tensions and tariff announcements. BMY's stock performance, influenced by regional economic uncertainties and a mixed earnings report, underscored the widespread pressures faced by pharmaceutical stocks amid anticipated tariffs on the industry. Every company has risks, and we've spotted 2 warning signs for Bristol-Myers Squibb you should know about. Find companies with promising cash flow potential yet trading below their fair value. The FDA approval for Bristol-Myers Squibb's Opdivo and Yervoy combination therapy could positively influence the company's narrative. By bolstering its immunotherapy portfolio, this development may enhance future revenue streams and strengthen earnings forecasts. Despite this key milestone, analysts remain cautious, emphasizing the challenges posed by increased generic competition and market dynamics. Over the last year, Bristol-Myers Squibb's total shareholder return, including dividends, was 7.90%. This performance contrasts with the broader US Pharmaceuticals industry, which saw an 11.50% decline over the same period. This indicates a stronger relative performance within the industry, as the company's strategic initiatives begin to resonate with shareholders. Short-term impacts on the company's stock, seen with a recent quarterly decline, suggest market concerns over broader economic uncertainties. This sentiment is reflected in the stock trading closely to analysts' price target of US$60.67, with only a 0.14% discount. The narrow gap indicates market alignment with consensus expectations, attributing the fall in share price more to external market conditions than internal company performance. Evaluate Bristol-Myers Squibb's prospects by accessing our earnings growth report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:BMY. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
