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Bristol-Myers Squibb Co. (BMY) is a renowned American multinational pharmaceutical company headquartered in New York City. As one of the largest pharmaceutical companies globally, Bristol-Myers Squibb (BMS) consistently ranks on the Fortune 500 list. In fiscal 2022, the company achieved total revenue of $46.2 billion.
Bristol-Myers Squibb focuses on discovering, developing, and marketing drugs across various therapeutic areas, including cardiovascular, cancer, and immune disorders. A significant area of focus for BMS is immuno-oncology, where it has established itself as a leader in drug development. Approximately 70% of BMS's total sales are derived from the U.S. market, reflecting its higher dependence on this region compared to its peers.
Recent achievements and collaborations highlight BMS's commitment to innovation and partnerships. On May 22, 2024, BMS joined NeoPhore Limited's oversubscribed Series B extension round. This additional investment will enable NeoPhore to explore novel biology associated with the DNA mismatch repair (MMR) pathway in cancer, and further advance its pre-clinical studies. NeoPhore aims to generate next-generation immuno-oncology therapeutics to improve clinical outcomes for cancer patients.
Another noteworthy collaboration was announced on June 5, 2024, with I-Mab, a U.S.-based global biotech company. This partnership will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody, with BMS's immune checkpoint inhibitor, nivolumab, and chemotherapy. The study, a multi-national Phase 1, will focus on advanced Claudin 18.2-positive gastric and esophageal cancers. BMS will supply nivolumab, which is designed to enhance T-cell function and improve anti-tumor responses.
Additionally, on June 5, 2024, Envisagenics, an AI-driven biotechnology company, announced a Series B fundraising round with participation from BMS. This funding will be utilized to further develop Envisagenics' pipeline of novel preclinical oncology assets using their cloud-based AI drug discovery platform, SpliceCore®. This collaboration underscores BMS's continued investment in innovative technologies and therapeutics.
Bristol-Myers Squibb's mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. Through strategic partnerships, cutting-edge research, and a commitment to therapeutic advancements, BMS continues to make significant strides in the biopharmaceutical industry.
Bristol Myers Squibb (BMY) announced that the European Medicines Agency (EMA) has validated its application for a new subcutaneous formulation of Opdivo® (nivolumab) for multiple solid tumor indications. This validation is based on the Phase 3 CheckMate -67T trial, which showed that subcutaneous nivolumab is noninferior in terms of pharmacokinetics and efficacy compared to the intravenous formulation. The new subcutaneous formulation aims to significantly reduce administration time to 3-5 minutes per injection, compared to longer IV infusions. The validation marks the start of EMA's centralized review process. If approved, the subcutaneous formulation could provide more convenience for patients, allowing them to receive the same quality of care in less time. The Phase 3 trial involved 495 patients with advanced or metastatic clear cell renal cell carcinoma, showing similar safety profiles between subcutaneous and IV formulations. Bristol Myers Squibb is committed to improving patient experiences and advancing innovative treatment formulations.
Bristol Myers Squibb (NYSE: BMY) will release its second quarter 2024 financial results on July 26, 2024. The company's executives will provide an overview of the financial outcomes and answer questions from investors and analysts during a conference call scheduled for 8:00 a.m. ET on the same day.
The live conference call can be accessed through a webcast available on the company’s investor relations website. For those who cannot register for the webcast, dial-in options are available for both U.S. and international participants. Conference materials will be provided on the investor relations website before the call begins. A replay of the webcast and the conference call will be accessible post-event.
Bristol Myers Squibb (NYSE: BMY) has announced the election of Michael R. McMullen to its Board of Directors, effective July 1, 2024. McMullen will also join the Audit Committee. Previously, McMullen was the CEO of Agilent Technologies, where he significantly increased the company's market capitalization and profitability. His extensive experience in global operations and delivering shareholder returns is expected to enhance Bristol Myers Squibb's long-term growth and pipeline progress.
McMullen has over 20 years of executive experience and has held various leadership roles at Agilent, including COO and President of the Chemical Analysis Group. He will continue to serve as a senior advisor to Agilent until October 31, 2024. The appointment increases Bristol Myers Squibb's Board size to 11, and McMullen will receive compensation as per the company’s director compensation program.
Bristol Myers Squibb (NYSE: BMY) has declared a quarterly dividend of $0.60 per share on its $0.10 par value common stock, payable on August 1, 2024, to stockholders of record as of July 5, 2024.
The company also announced a quarterly dividend of $0.50 per share on its $2.00 convertible preferred stock, payable on September 3, 2024, to stockholders of record as of August 6, 2024.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has granted accelerated approval for Augtyro™ (repotrectinib), a new tyrosine kinase inhibitor (TKI), for treating NTRK-positive solid tumors in patients aged 12 and older. This approval is based on Phase 1/2 TRIDENT-1 trial results, showing significant response rates in both TKI-naïve and TKI-pretreated patients.
Among TKI-naïve patients, 58% had a confirmed objective response with a median follow-up of 17.8 months. In TKI-pretreated patients, the overall response rate was 50%. Intracranial responses were also noted in patients with CNS metastases. Augtyro showed manageable safety profiles, though notable adverse events included dizziness, hepatotoxicity, and pneumonitis.
Continued approval may depend on further confirmatory trials. This is the second indication for Augtyro in the U.S., following its approval for ROS1-positive NSCLC in November 2023. The recommended dosage is 160 mg daily for the first 14 days, then twice daily until disease progression or unacceptable toxicity.
Envisagenics, a biotechnology company specializing in RNA splicing therapeutics, has completed a Series B funding round. The round included existing investors Third Kind Venture Capital, Empire State Development, and Red Cell Partners, along with new strategic investor Bristol Myers Squibb (NYSE: BMY).
The funds will be used to advance Envisagenics' pipeline of preclinical oncology assets using its AI drug discovery platform, SpliceCore®. This platform integrates machine learning and high-performance computing to identify novel splicing isoforms.
Envisagenics has collaborations with Biogen, the Lung Cancer Initiative at Johnson & Johnson, and Bristol Myers Squibb. CEO Maria Luisa Pineda stated that the funding will aid in developing immunotherapies and disease-modifying ASOs for neurodegenerative diseases. The goal is to advance their first asset into clinical trials.
I-Mab (NASDAQ: IMAB), a global biotech company, has announced a clinical trial collaboration with Bristol Myers Squibb (NYSE: BMY). The focus is on evaluating the combination of givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, with nivolumab and chemotherapy for treating advanced gastric and esophageal cancers. The collaboration leverages promising safety and efficacy data from givastomig's monotherapy study, presented at the European Society of Medical Oncology Congress 2023. The multi-national Phase 1 study will be conducted by I-Mab, with Bristol Myers Squibb supplying nivolumab. The aim is to explore the potential of this combination as a first-line treatment for Claudin 18.2-positive cancers.
Bristol Myers Squibb announced the first presentation of Phase 3 CheckMate -9DW trial results showing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves overall survival (OS) and objective response rate (ORR) in patients with advanced hepatocellular carcinoma (HCC) compared to lenvatinib or sorafenib.
Median OS for Opdivo plus Yervoy was 23.7 months versus 20.6 months for lenvatinib or sorafenib. The ORR for Opdivo plus Yervoy was 36%, more than double the 13% for lenvatinib or sorafenib, with a median duration of response of 30 months versus 12.9 months.
The ASCO Annual Meeting will feature these results, highlighting a reduced risk of symptom deterioration and a manageable safety profile.
Bristol Myers Squibb (NYSE: BMY) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. CEO and Board Chair Christopher Boerner, Ph.D., will partake in a fireside chat on June 11, 2024, starting at 11:20 a.m. ET. Investors and the public can listen via a live webcast accessible through the company's investor relations website. An archived version will be available post-event.
Bristol Myers Squibb's Breyanzi has shown significant clinical benefits for patients with various B-cell malignancies, according to new data presented at the 2024 ASCO Annual Meeting. The three-year follow-up from the Phase 3 TRANSFORM trial demonstrates sustained event-free survival and durable responses in patients with large B-cell lymphoma (LBCL), outperforming standard care.
The study also highlights Breyanzi's consistent efficacy and safety in mantle cell lymphoma (MCL) and follicular lymphoma (FL) across different subgroups, regardless of the number of prior treatments or use of bridging therapy. This underscores Breyanzi's potential for earlier lines of treatment and relapsed or refractory cases. Recently, the FDA granted accelerated approval for Breyanzi in relapsed or refractory FL and MCL, expanding its use across four types of B-cell lymphomas.
These findings emphasize Breyanzi's role as a transformative CAR T cell therapy with a robust clinical profile, offering hope for improved patient outcomes.