Bristol-Myers Squibb (BMY)

Bristol Myers Squibb (NYSEBMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU).

Bristol Myers Squibb (NYSEBMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended 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 follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

 

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PALM BEACH, Fla., Jan. 22, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The demand for effective pancreatic cancer treatments is and has been undeniably high. The growing number of diagnoses, with the aggressive nature of the disease, fuels the market. This demand is further amplified by rising awareness and a focus on personalized medicine, leading to potentially more targeted and effective therapies. Pancreatic cancer remains a formidable foe, with the American Cancer Society estimating over 66,000 new diagnoses and a staggering 51,750 deaths in the US alone for 2024. This translates to 3% of all cancers and a grim 7% of all cancer fatalities, highlighting the urgent need for improved treatment options. The pancreatic cancer treatment market is driven by several factors, including the rising prevalence of obesity, alcohol consumption, and smoking. These lifestyle factors, combined with the growing geriatric population, are expected to fuel market growth. Additionally, personal or family history of pancreatitis and BRCA2 mutation predisposes individuals to pancreatic cancer, further driving demand for effective treatments. A recent report from S&S Insider said that the Pancreatic Cancer Treatment Market size is expected to reach USD 10.53 billion by 2032 and grow at a CAGR of 15.85%. The report continued: “On the supply side, pharmaceutical companies are actively involved in research and development… Moreover, 322 studies were under clinical trial according to clinicaltrail.com in their 3, and 4 phases. Governments also play a crucial role with increased funding for research initiatives and streamlined regulatory processes can accelerate the development and approval of new treatments. Collaborations between public and private entities foster progress, with the shared goal of improving patient outcomes. The overall market for pancreatic cancer treatments is expected to experience significant growth due to the increasing prevalence of the disease and the ongoing search for effective therapies. The development of innovative approaches… offers hope for patients and presents opportunities for pharmaceutical companies and research institutions.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQONCY) (TSX: ONC), GSK plc NYSE: GSKNYSEGSK)(NASDAQ: AZNNASDAQAZN, Gilead Sciences, Inc. (NASDAQ: GILDNASDAQ), Bristol Myers Squibb (NYSE: BMYBMY).

-- Bristol Myers Squibb exercises an exclusive license option for ArsenalBio’s AB-4000 series programs --

Bristol Myers Squibb (NYSEBMY) today announced that the company will present at J.P. Morgan’s 43rd Annual Healthcare Conference on Monday, January 13, 2025.

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.1,2 The approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile vs. intravenous (IV) Opdivo.1,3

Bristol Myers Squibb (NYSEBMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.

Bristol Myers Squibb (NYSEBMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

Bristol Myers Squibb (NYSEBMY) will announce results for the fourth quarter of 2024 on Thursday, February 6, 2025. Company executives will review financial results and address inquiries from investors and analysts during a conference call beginning at 8:00 a.m. ET on the same date.

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Bristol Myers Squibb (NYSEBMY) today announced that its Board of Directors has declared a quarterly dividend of sixty-two cents ($0.62) per share on the $0.10 par value common stock of the company. The dividend is payable on February 3, 2025, to stockholders of record at the close of business on January 3, 2025.

Bristol Myers Squibb (NYSEBMY) announced results from 18 presentations reinforcing its leadership in cell therapy, with data demonstrating efficacy, durability and safety of currently available therapies in blood cancers and highlighting the potential of its pipeline for future indications including autoimmune diseases. These results, covering a breadth of potential targets within an expanding range of disease areas, were presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.

PALM BEACH, Fla., Dec. 18, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - One of the most common malignancies in the world today is gastric cancer. The incidence rate is influenced by various factors, including the aging of the population, dietary choices, lifestyle changes, and the prevalence of Helicobacter pylori infection. Growth in the market is driven by an increase in demand for diagnostic tools, therapies, and supporting care in tandem with a rise in the number of diagnosed cases. A recent report from MarketsAndMarkets projected that the global gastric cancer market accounted for USD 3.01 billion in 2023 and is expected to reach USD 18.43 billion by 2034 with a CAGR of 17.92% during the forecast period 2024-2034. The report said: “The market will grow due to the rising incidence of gastric cancer, improvements in diagnostic technologies, emerging treatments and therapies, personalized medicine and precision medicine, government funding and initiatives, and technological advancements in surgery and minimally invasive procedures. Growth in the market is driven by an increase in demand for diagnostic tools, therapies, and supporting care in tandem with a rise in the number of diagnosed cases. For instance, in January 2024, Roche revealed encouraging findings from the Phase III RAINBOW research, which assessed the safety and effectiveness of ramucirumab when combined with chemotherapy to treat advanced stomach or gastroesophageal junction (GEJ) cancer.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQONCY) (TSX: ONC), Novartis AG NYSE: NVSNYSENVS)(NYSE: PFENYSEPFE, GSK plc (NYSE: GSKNYSE), Bristol Myers Squibb (NYSE: BMYBMY).

Bristol Myers Squibb (NYSEBMY) today announced that the company will participate in Citi’s 2024 Global Healthcare Conference.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of more than 90 data disclosures, including 18 oral presentations, across company-sponsored studies, investigator-sponsored studies and collaborations from its hematology and cell therapy research programs at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held from December 7 to 10 in San Diego, California. These data underscore the depth and diversity of the company’s approved products and investigational pipeline and spotlight the next wave of innovative treatment approaches with the potential to transform patient outcomes across hematology and other areas of disease.

Bristol Myers Squibb (NYSEBMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) compared to chemotherapy in this patient population. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the recommendation and make their decision.

Bristol Myers Squibb (NYSEBMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in January 2025.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of data across its cardiovascular portfolio at the American Heart Association (AHA) Annual Scientific Sessions, taking place November 16-18, 2024, in Chicago, Illinois. New analyses include updated results from the nearly two-year post-launch evaluation of the CAMZYOS® (mavacamten) Risk Evaluation and Mitigation Strategy (REMS) Program and real-world and long-term extension data reinforcing the efficacy and safety profile of CAMZYOS, as well as data on behalf of the BMS-Pfizer Alliance on ELIQUIS® (apixaban) and the BMS-Johnson & Johnson Collaboration on milvexian.

Bristol Myers Squibb (NYSEBMY) today announced that the company will participate in two upcoming investor conferences in November 2024.

Bristol Myers Squibb (NYSEBMY) today announced new topline results from the Phase 3 EMERGENT-4 and EMERGENT-5 open-label trials evaluating the long-term efficacy, safety, and tolerability of COBENFY™ (xanomeline and trospium chloride) in adults with schizophrenia over 52 weeks of treatment. Data were presented at the 2024 Psych Congress, taking place from October 29 – November 2, 2024 in Boston, MA.

Bristol Myers Squibb (NYSEBMY) today reports results for the third quarter of 2024.

Bristol Myers Squibb (NYSEBMY) today announced that new clinical and health economics and outcomes research data (HEOR) from its neuropsychiatry portfolio evaluating COBENFY™ (xanomeline and trospium chloride) in schizophrenia in adults will be presented at Psych Congress 2024, taking place October 29 – November 2 in Boston, Massachusetts.

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.1 The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.1 Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen.1