Bristol-Myers Squibb (BMY)

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.

EQNX::TICKER_START (NASDAQONCY),(TSX:ONC),NYSE:NVSNYSENVS)(NYSE:PFENYSEPFE,(NYSE:GSKNYSE),(NYSE:BMYBMY) EQNX::TICKER_END

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 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

Collaboration Combines Prime Medicine’s Precise, Multiplex Gene Editing Capabilities with Bristol Myers Squibb’s Broad Expertise in Development and Commercialization of Novel Cell Therapies  

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).

Edgewise Therapeutics was a massive winner last week after positive results on its cardiovascular treatment. This there still room for the stock to run?

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.