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Bristol-Myers Squibb Company (BMY) is a global biopharmaceutical leader developing innovative therapies in oncology, cardiovascular diseases, and immunology. This dedicated news hub provides investors and healthcare professionals with direct access to BMY's latest developments, including FDA approvals, clinical trial results, and strategic partnerships.
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Bristol Myers Squibb (NYSE: BMY) announced that the European Commission has approved Opdivo (nivolumab) for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. The decision, based on the Phase 3 ATTRACTION-3 trial, highlights a 23% reduction in the risk of death with Opdivo compared to chemotherapy, improving median overall survival to 10.9 months. Opdivo's favorable safety profile showed significantly fewer treatment-related adverse events than chemotherapy. This approval allows for expanded treatment options across Europe.
Bristol Myers Squibb (NYSE:BMY) has completed its acquisition of MyoKardia, Inc. for approximately $13.1 billion in cash, enhancing its cardiovascular portfolio. MyoKardia will now operate as a wholly-owned subsidiary. The acquisition brings mavacamten, a potential first-in-class treatment for obstructive hypertrophic cardiomyopathy (HCM), with plans for a New Drug Application to the FDA in Q1 2021. The merger was executed without a vote from MyoKardia’s stockholders, following a successful tender offer for $225 per share, with about 78.9% of shares validly tendered.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA will not complete its review of the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) by the scheduled November 16, 2020 date due to an inability to inspect a third-party manufacturing facility amid COVID-19 restrictions. The BLA remains under review, but no new action date has been provided. This review is critical as FDA approval by December 31, 2020 is a milestone for holders of Contingent Value Rights (CVR) linked to the Celgene acquisition.
Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat at Wolfe Research’s 2nd Annual Virtual Healthcare Conference on November 18, 2020. The session, featuring CEO Giovanni Caforio, begins at 9:15 a.m. EST. Investors and the public can access the live webcast at investor.bms.com, with an archived version available later that day. Bristol Myers Squibb is dedicated to developing innovative medicines for serious diseases. For more information, visit BMS.com.
Bristol Myers Squibb (NYSE: BMY) announces research presentations at the 62nd ASH Annual Meeting, highlighting nearly 100 studies focused on treatments for blood cancers. Key studies include analyses of CD19-targeted CAR T cell therapy liso-cel and BCMA-targeted therapies for multiple myeloma. Research on the quality of life improvements with Onureg in acute myeloid leukemia and Luspatercept in beta thalassemia are also featured. This event underscores the company's commitment to innovative treatment options for serious hematologic diseases.
Bristol Myers Squibb (NYSE:BMY) has priced a public offering of senior unsecured notes totaling $7 billion, set to close on November 13, 2020. The offering includes six tranches with varying maturities and interest rates, aimed at funding the proposed $13.1 billion acquisition of MyoKardia. While the offering is not contingent on the acquisition's completion, a mandatory redemption at 101% of the notes' aggregate principal will occur if the acquisition is not finalized by June 30, 2021, or if Bristol Myers opts not to pursue it. Proceeds will also cover fees and general purposes.
Bristol Myers Squibb (NYSE: BMY) announced the European Commission's approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC). This regimen is the first dual immunotherapy option approved in the EU for patients without sensitizing EGFR mutation or ALK translocation. The decision is based on the CheckMate -9LA trial results, which demonstrated significant improvements in overall survival, progression-free survival, and overall response rate compared to chemotherapy alone.
Bristol Myers Squibb (NYSE:BMY) announced data from 26 studies to be presented at ACR Convergence 2020, showcasing its immunology pipeline. Key highlights include:
- Deucravacitinib: Phase 2 trial results met primary and secondary endpoints for active psoriatic arthritis.
- Orencia: 13 presentations on its effectiveness in rheumatoid arthritis, including a real-world analysis.
- Iberdomide: Phase 2b trial met its primary endpoint in systemic lupus erythematosus patients.
These findings reflect the company's commitment to advancing therapies for immune-mediated diseases.
Bristol Myers Squibb (NYSE:BMY) reported a robust third quarter 2020 with total revenues of $10.54 billion, marking a 75% increase from $6.00 billion in Q3 2019. The U.S. revenue surged 88% to $6.5 billion. Non-GAAP diluted EPS rose 39% to $1.63, while GAAP diluted EPS saw a slight decline of 1% at $0.82. The company also raised its financial guidance for 2020, expecting non-GAAP EPS in the range of $6.25 - $6.35. Key product revenues included Revlimid at $3.03 billion and Eliquis at $2.1 billion.
Bristol Myers Squibb (NYSE: BMY) announced the expiration of the waiting period under the Hart-Scott-Rodino Act concerning its $13.1 billion tender offer to acquire MyoKardia at $225.00 per share. The waiting period expired on November 3, 2020, which fulfills a condition for the transaction's consummation, pending majority shareholder support and customary closing conditions. The tender offer will expire on November 16, 2020, unless extended.