Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) announced that the European Commission has granted full Marketing Authorization for Inrebic® (fedratinib). This treatment is specifically for adult patients with myelofibrosis-related splenomegaly or symptoms who are naive to JAK inhibitors or have failed treatment with ruxolitinib. Inrebic is the first once-daily oral therapy to significantly reduce spleen volume and symptoms for these patients. The approval covers all EU member states plus Norway, Iceland, and Liechtenstein.

Results from the pivotal JAKARTA and JAKARTA2 studies supported this approval, highlighting a critical new treatment option for patients.

Bristol Myers Squibb (NYSE: BMY) announced FDA approval for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more systemic therapies. Notable data from the TRANSCEND NHL 001 trial showed a 73% response rate among 192 patients treated. Breyanzi offers a single dose of 50 to 110 x 10^6 CAR-positive T cells and a 24-day turnaround time. The therapy has a REMS program due to potential side effects, including cytokine release syndrome and neurologic toxicities.

Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat during Guggenheim’s Virtual Healthcare Talks | 2021 Oncology Day on February 12, 2021, at 12 p.m. ET. Chris Boerner, Ph.D., Executive Vice President and Chief Commercial Officer, will address questions during the session. Investors and the public can listen to the live webcast at investor.bms.com, where related materials will also be available. An archived version of the chat will be accessible later in the day.

Bristol Myers Squibb (NYSE:BMY) reported robust Q4 and full-year results for 2020, showcasing a 39% increase in quarterly revenues to $11.1 billion and a 63% increase in annual revenues to $42.5 billion. Non-GAAP earnings per share (EPS) rose by 20% to $1.46 in Q4, while full-year non-GAAP EPS increased 37% to $6.44. The growth was driven mainly by the acquisition of Celgene, enhancing the product pipeline and market performance. Despite a reported net loss of $10 billion in Q4, the company emphasized its long-term growth strategy and disciplined development approach to sustain momentum.

Bristol-Myers Squibb (NYSE:BMY), through its subsidiary Celgene, announced the launch of 20 offers to purchase various notes for a total cash purchase price of up to $4 billion. The offers include up to $950 million for 2023 Pool Notes, $1.5 billion for 2024 Pool Notes, $650 million for 2025 Pool Notes, and $900 million for High Coupon Pool Notes. Tendering deadlines for holders to receive the Total Consideration are set for February 18, 2021 for early tender and March 4, 2021 for expiration. The Offers are aimed at optimizing the company's debt structure.

Bristol Myers Squibb (NYSE: BMY) has secured a global exclusive license from The Rockefeller University to develop and commercialize a new monoclonal antibody (mAb) treatment targeting the SARS-CoV-2 virus. This novel therapy combines two highly potent mAbs designed to neutralize the virus and block its spike protein, making it effective against various variants. Phase 1 clinical trials are currently underway to determine dosing and safety. Should the trials succeed, Bristol Myers Squibb aims to ensure the treatment's global accessibility and affordability.

Bristol Myers Squibb (NYSE: BMY) and WuXi STA, a subsidiary of WuXi AppTec, announced the agreement for WuXi STA to purchase Bristol Myers Squibb's manufacturing facility in Couvet, Switzerland. This facility will be WuXi STA's first in Europe, enhancing its capabilities and capacity. The transaction is expected to close by Q2 2021, pending regulatory approvals. The Couvet site will continue operating under Bristol Myers Squibb until the close, which includes operational assets and skilled workforce. The facility emphasizes quality, safety, and efficiency.

Bristol Myers Squibb (NYSE:BMY) announced positive results from its pivotal Phase 3 trial, POETYK PSO-2, evaluating deucravacitinib, a selective TYK2 inhibitor, for moderate to severe plaque psoriasis. The trial demonstrated that patients receiving deucravacitinib 6 mg daily achieved significant improvement in Psoriasis Area and Severity Index (PASI 75) and a clear assessment on the Physician's Global Assessment (sPGA). It also outperformed Otezla in key secondary endpoints. The safety profile remains consistent with prior studies. Further evaluation will be shared at a medical meeting.

Bristol Myers Squibb (NYSE:BMY) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Zeposia (ozanimod) to treat adults with moderately to severely active ulcerative colitis, setting a PDUFA goal date of May 30, 2021. The sNDA is based on the True North Phase 3 trial, which demonstrated significant efficacy for Zeposia in achieving clinical remission at 10 weeks and maintenance at 52 weeks. The trial met primary endpoints with consistent safety results. Zeposia is already approved for multiple sclerosis.