Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 ODYSSEY-HCM trial for Camzyos (mavacamten) did not meet its dual primary endpoints in treating non-obstructive hypertrophic cardiomyopathy (nHCM). The trial, which enrolled 580 adult patients, evaluated changes in Kansas City Cardiomyopathy Questionnaire scores and peak oxygen consumption at Week 48 compared to placebo.

No new safety signals were observed during the trial. While these results are disappointing for nHCM treatment, the company emphasized that these findings do not impact Camzyos's established benefits for obstructive HCM patients, where it has demonstrated favorable outcomes in clinical trials and real-world evidence across more than 50 countries.

Bristol Myers Squibb (NYSE: BMY) received FDA approval for Opdivo plus Yervoy as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). The approval is based on the Phase 3 CheckMate-9DW trial results, where the combination therapy showed superior overall survival of 23.7 months versus 20.6 months with lenvatinib or sorafenib, reducing death risk by 21%.

Key findings include:

• 38% three-year survival rate with Opdivo plus Yervoy versus 24% with comparator therapy
• 36.1% overall response rate compared to 13.2% for lenvatinib/sorafenib
• Median duration of response of 30.4 months versus 12.9 months

This approval converts the previous 2020 accelerated approval to full approval and expands the indication to first-line treatment. The safety profile remained consistent with previous findings, though serious adverse reactions occurred in 53% of patients receiving the combination therapy.

Bristol Myers Squibb (NYSE: BMY) has received FDA approval for Opdivo® plus Yervoy® as a first-line treatment for MSI-H/dMMR colorectal cancer in adults and pediatric patients (12+ years). The approval is based on the Phase 3 CheckMate-8HW trial (n=839), which demonstrated:

- 79% reduction in disease progression/death risk vs chemotherapy in first-line setting
- 38% reduction vs Opdivo monotherapy across all therapy lines
- Median PFS was not reached for the combination therapy vs 39.3 months for Opdivo alone
- Overall response rate of 71% for combination vs 58% for monotherapy

The approval came more than two months ahead of schedule following Breakthrough Therapy Designation and Priority Review status. This marks BMY's ninth indication for Opdivo-based treatment in gastrointestinal space.

Viz.ai has secured its third consecutive Edison Award™ for innovation in cardiovascular health diagnostics, specifically for its Viz HCM module. The AI-powered software, developed in partnership with Bristol Myers Squibb (NYSE:BMY), received FDA De Novo approval in August 2023 for detecting hypertrophic cardiomyopathy (HCM).

The Viz HCM module analyzes 12-lead ECGs across healthcare systems to identify potential HCM cases and alert cardiology teams. Recent data from Cleveland Clinic demonstrated the software's effectiveness, identifying 574 HCM patients during a 9-month period. This is particularly significant as HCM, despite being the most commonly inherited cardiac disease, has only a 15% diagnosis rate.

The Edison Awards, named after Thomas Alva Edison, recognize excellence in innovation and business success. The winners were announced at the Edison Awards Gala on April 3, 2025, in Fort Myers, FL.

Bristol Myers Squibb (NYSE: BMY) received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) for resectable non-small cell lung cancer (NSCLC) treatment in the EU. The recommendation is for a perioperative regimen combining neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo monotherapy in adult patients with tumor PD-L1 expression ≥1%.

The recommendation is based on the Phase 3 CheckMate -77T trial, which demonstrated significant improvement in event-free survival and clinically meaningful improvements in pathologic complete response and major pathologic response. The safety profile aligned with previous NSCLC studies.

This marks BMY's second Opdivo-based regimen for resectable NSCLC in the EU. The treatment received FDA approval in October 2024 for similar indications in the US. The European Commission will review the recommendation, with a final decision expected within two months.

Bristol Myers Squibb (NYSE: BMY) has received a positive CHMP opinion for a new subcutaneous formulation of Opdivo® (nivolumab) across multiple solid tumor indications. The recommendation is based on the Phase 3 CheckMate -67T trial, which demonstrated noninferiority in pharmacokinetics and consistent efficacy compared to the intravenous formulation.

The trial showed an objective response rate of 24% for subcutaneous Opdivo versus 18% for IV Opdivo. The safety profile remained consistent between both formulations. The European Commission's final decision is expected by June 2, 2025.

The subcutaneous formulation, co-formulated with recombinant human hyaluronidase (rHuPH20), offers potential benefits including reduced administration time and improved healthcare system efficiency. The U.S. FDA has already approved this formulation under the brand name Opdivo Qvantig on December 27, 2024.

Viz.ai announced new clinical data showing the effectiveness of its Viz HCM module, developed in partnership with Bristol Myers Squibb (NYSE:BMY), in detecting hypertrophic cardiomyopathy (HCM). The module, which received FDA De Novo approval in August 2023, is the first AI algorithm cleared for HCM detection.

Four studies presented at ACC 2025 demonstrated significant results:

• Cleveland Clinic study identified 574 HCM patients with high accuracy
• 20% of patients could have been diagnosed more than one year earlier
• In a multicenter study of 145,848 screened patients, 3% were flagged for suspected HCM, leading to 17 new HCM diagnoses
• Algorithm showed 56% sensitivity and 100% specificity in detecting HCM confirmed by cardiac MRI

Cardurion Pharmaceuticals has appointed Karen Lewis as Chief People Officer, bringing over 25 years of human resources experience to the clinical-stage biotechnology company. Lewis joins from Apellis Pharmaceuticals (APLS), where she served as Chief People Officer and led organizational growth from 200 to over 900 employees globally while supporting the launch of two drug products.

Prior to Apellis, Lewis held leadership positions at Axcella Health, Biogen (BIIB), Amazon, and Bristol-Myers Squibb (BMY). At Biogen, she served as Vice President of Global Talent Acquisition and headed HR for U.S. commercial and Asia Pacific/Latin America operations. Lewis holds a B.S. in biology from Rider University and began her career as a research scientist before transitioning to HR.

Bristol Myers Squibb (NYSE: BMY) has received European Commission approval for Breyanzi to treat adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The approval is based on the Phase 2 TRANSCEND FL study results, showing:

• 97.1% overall response rate
• 94.2% complete response rate
• 75.7% of patients maintained response at 18 months
• Median time to first response of 0.95 months

Safety profile remained consistent with previous trials, with 58% of patients experiencing cytokine release syndrome (only 0.8% Grade 3) and 16% experiencing neurologic toxicities (3% Grade 3). The approval extends to all EU member states and EEA countries.