Articles from Bristol Myers Squibb

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.

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.

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

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.1 COBENFY represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.2,3,4

Bristol Myers Squibb (NYSEBMY) today announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu (deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis. The primary endpoint was met, with a statistically significant improvement in the scalp-specific Physician’s Global Assessment (ss-PGA) response of 0 or 1 (clear/almost clear) at 16 weeks, with more than three times as many patients achieving ss-PGA 0/1 with Sotyktu treatment compared to those on placebo (48.5% versus 13.7%, respectively; p<0.0001).

Bristol Myers Squibb (NYSEBMY) today announced new data from the Phase 3 DAYBREAK trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing forms of multiple sclerosis. These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: RADIANCE, −0.27; SUNBEAM, −0.35).

Bristol Myers Squibb (NYSEBMY) today announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo® (nivolumab) plus Yervoy® (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.

Bristol Myers Squibb (NYSEBMY) will announce results for the third quarter of 2024 on Thursday, October 31, 2024. 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.

Bristol Myers Squibb (NYSEBMY) today announced that its Board of Directors has declared a quarterly dividend of sixty cents ($0.60) per share on the $0.10 par value common stock of the company. The dividend is payable on November 1, 2024, to stockholders of record at the close of business on October 4, 2024.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2024 to be held from September 13-17 in Barcelona, Spain.

With cancer patients top of mind, teams of Bristol Myers Squibb (NYSEBMY) employees will relay Coast 2 Coast 4 Cancer (C2C4C) this year and cycle from Oregon to New Jersey with the goal of raising $1 million in support of the V Foundation for Cancer Research. Since the ride’s inception in 2014, Bristol Myers Squibb employees – many of whom have been personally impacted by cancer – have come together to fundraise, resulting in more than $12.7 million in donations for cancer research in North America.

Bristol Myers Squibb (NYSEBMY) today announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study evaluating CAMZYOS® (mavacamten) in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

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

Bristol Myers Squibb (NYSEBMY) today announced the presentation of research across its robust cardiovascular portfolio at the European Society of Cardiology (ESC) Congress, taking place August 30 – September 2, 2024, in London, England. Data to be presented at the meeting includes long-term extension data evaluating the efficacy and safety profile of CAMZYOS® (mavacamten) up to 180 weeks (3.5 years) for the treatment of New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM), 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 U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.

Bristol Myers Squibb (NYSEBMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Validation of the application confirms the submission is complete and allows the scientific review to begin under the EMA’s centralized review procedure.

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

Bristol Myers Squibb (NYSEBMY) today announced that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The application was based on results from the Phase 3 CheckMate -9DW trial and validation of the application confirms the submission is complete and begins the EMA’s centralized procedure review.

Bristol Myers Squibb (NYSEBMY) today announced that the company will participate in Virtual Targeted Protein Degradation Day hosted by UBS.

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. 

Bristol Myers Squibb (NYSEBMY) today announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

Bristol Myers Squibb (NYSEBMY) will announce results for the second quarter of 2024 on Friday, July 26, 2024. 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.

Bristol Myers Squibb (NYSEBMY) today announced that its Board of Directors has elected independent director Michael R. McMullen to the Board, effective July 1, 2024. Mr. McMullen will serve as a member of the Audit Committee of the Board of Directors.

Bristol Myers Squibb (NYSEBMY) today announced that its Board of Directors has declared a quarterly dividend of sixty cents ($0.60) per share on the $0.10 par value common stock of the company. The dividend is payable on August 1, 2024, to stockholders of record at the close of business on July 5, 2024.

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.1 The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors.1 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1

Bristol Myers Squibb (NYSEBMY) today announced the first presentation of results from the Phase 3 CheckMate -9DW trial evaluating the dual immunotherapy combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) compared to investigator’s choice of lenvatinib or sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Results from the study will be featured in a late-breaking oral presentation at the 2024 ASCO® Annual Meeting today, June 4, at 9:45 a.m. CDT (#LBA4008).

Bristol Myers Squibb (NYSEBMY) today announced that the company will participate in the Goldman Sachs 45th Annual Global Healthcare Conference.

Bristol Myers Squibb (NYSEBMY) today announced data from three studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzi as a second-line treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL), results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trial in relapsed or refractory follicular lymphoma (FL).

Bristol Myers Squibb (NYSEBMY) today announced results from three updated analyses from the CheckMate -77T, CheckMate -816, and CheckMate -9LA studies supporting Opdivo® (nivolumab) and Opdivo-based combinations in early stage and advanced non-small cell lung cancer (NSCLC). Data are being presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from May 31 to June 4, 2024, in Chicago, IL.

Bristol Myers Squibb (NYSEBMY) today announced results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib) compared to standard of care chemotherapy in patients with locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy. At a median follow-up of 9.4 months, KRAZATI demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint, as assessed by Blinded Independent Central Review (BICR) compared to docetaxel (HR: 0.58; [95% CI, 0.45-0.76]; P <0.0001). Median PFS was 5.5 months for KRAZATI compared to 3.8 months for docetaxel. Overall response rate (ORR) as assessed by BICR was also significantly higher with KRAZATI compared to docetaxel (32% vs 9%; odds ratio, 4.68; P < 0.0001). The median duration of response (mDOR) was 8.31 months (95% CI, 6.05–10.35) versus 5.36 months (95% CI, 2.86–8.54), respectively.

Bristol Myers Squibb (NYSEBMY) today announced the U.S. Food and Drug Administration (FDA) has granted approval for 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 mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies. In relapsed or refractory MCL, Breyanzi is delivered as a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.

Bristol Myers Squibb (NYSEBMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). With this approval, Opdivo in combination with cisplatin and gemcitabine becomes the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of data across its oncology and hematology portfolio at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2024 Hybrid Congress. Data from more than 130 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning approximately 25 cancer types and serious blood disorders.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of data at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 28-31, 2024 in Miami, FL.

Bristol Myers Squibb (NYSEBMY) today announced ASPIRE (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity), a 10-year strategy to advance access to our innovative treatments and help patients in low- and middle-income countries (LMICs) gain access to potentially life-saving medicines. This strategy supports the company’s commitment to reach more than 200,000 patients in LMICs by 2033 with its innovative treatments.

Bristol Myers Squibb (NYSEBMY) today announced the launch of Live Your PosSCZible, a national campaign in partnership with the schizophrenia community focused on elevating lived experiences and empowering patients and care partners with educational, community and peer resources to help navigate care.

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all 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. The updated goal date is December 29, 2024.

Bristol Myers Squibb (NYSEBMY) today announced new four-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. After four years of continuous treatment, Week 208 responses for Psoriasis Area and Severity Index (PASI) 75 and 90 were 71.7% and 47.5%, respectively, and 57.2% for static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear), using modified nonresponder imputation (mNRI). The safety profile of Sotyktu at Year 4 remained consistent with the established safety profile, with no new safety signals identified.

Bristol Myers Squibb (NYSEBMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for 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. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.*

Bristol Myers Squibb (NYSEBMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen.

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

Bristol Myers Squibb (NYSEBMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all 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. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025.

 

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) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. 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 June 2024.

Bristol Myers Squibb (NYSEBMY) today reports results for the first quarter of 2024, which reflect meaningful progress in the company's growth portfolio and pipeline.

Bristol Myers Squibb (NYSEBMY) and Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M in upfront and milestone payments. As part of the agreement, Cellares will optimize, automate, and tech-transfer select Bristol Myers Squibb CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use. The Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories in the U.S., EU, and Japan.

Bristol Myers Squibb (NYSEBMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).

Bristol Myers Squibb (NYSEBMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. These data were presented in a poster titled, “Long-Term Safety of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F74) and in the Oral Session “Long-Term Metabolic Outcomes Associated With KarXT (Xanomeline and Trospium): Interim Results From Pooled, Long-Term Safety Studies EMERGENT-4 and EMERGENT-5” at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.

Bristol Myers Squibb (NYSEBMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.

Bristol Myers Squibb (NYSEBMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). This approval of Reblozyl covers all EU member states.*

Bristol Myers Squibb (NYSEBMY) today published its 2023 Environmental, Social, and Governance (ESG) Report detailing the company’s meaningful progress, evolved strategy, and aspirational goals toward its ESG efforts. The company’s ESG strategy is embedded in its mission to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.

 

Bristol Myers Squibb (NYSEBMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12.

Bristol Myers Squibb (NYSEBMY) today unveiled a $1.8 million initiative to advance health equity by addressing social determinants of health (SDoH) in four countries with underserved patient needs, including Brazil, India, Thailand, and the United Kingdom. The new health equity grants are an extension of the company’s broader long-term commitment to invest $150M in health equity by 2025.

Bristol Myers Squibb (NYSEBMY) today announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place April 6-8, 2024 in Atlanta, Georgia.

Bristol Myers Squibb (NYSEBMY) today announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union (EU) for use in earlier lines of therapy for relapsed and refractory multiple myeloma. This expanded approval of Abecma covers all EU member states.* In the EU, Abecma has maintained its Orphan Designation for the treatment of multiple myeloma.

Bristol Myers Squibb (NYSEBMY) today announced the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy met its primary endpoint of improved overall survival (OS) compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.

Award-winning actor Ted Danson, who lives with plaque psoriasis, teams up with Bristol Myers Squibb for the inspiring “SO, Have You Found It?” campaign. This initiative spotlights the resilience of around two million Americans with moderate to severe plaque psoriasis, aiming to amplify their voices, underscoring the strength of their inner vibe, the “it” factor that makes someone uniquely them.i The campaign signifies a shift in dialogue from the challenges associated with the condition to empowering individuals to confidently navigate their plaque psoriasis in partnership with their dermatologists.

Bristol Myers Squibb (NYSEBMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics, Inc. (“Karuna”). With the acquisition's completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb (“BMS”).

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA.

Bristol Myers Squibb (NYSEBMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated 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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). In R/R CLL or SLL, Breyanzi is delivered through a treatment process which culminates in a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.