Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (BMY) has received European Commission approval for a perioperative regimen of Opdivo with chemotherapy followed by adjuvant Opdivo for treating resectable non-small cell lung cancer (NSCLC) with PD-L1 expression ≥1%. The approval is based on the CheckMate-77T trial, which demonstrated a 42% reduction in the risk of disease recurrence, progression, or death compared to chemotherapy and placebo. After 24 months, 65% of patients in the Opdivo arm showed event-free survival versus 44% in the control arm. The trial also showed improvements in pathologic complete response and major pathologic response, with a safety profile consistent with previous studies. This approval makes Opdivo the only PD-(L)1 inhibitor approved for both perioperative and neoadjuvant-only treatment of resectable NSCLC in the EU.

Bristol Myers Squibb (NYSE: BMY) has appointed Cari Gallman as Executive Vice President, General Counsel and Chief Policy Officer, effective immediately. Gallman, who has been with BMY for 10 years and most recently served as Executive Vice President of Corporate Affairs, succeeds Sandra Leung, who is retiring after 33 years with the company.

In her new role, Gallman will lead the law department, overseeing intellectual property, commercial and regulatory law, litigation, securities and corporate governance, transactions, corporate security, compliance and ethics, as well as global and U.S. policy and government affairs. She brings extensive experience in pharmaceutical law and compliance, along with expertise in legal, policy, and communications.

Bristol Myers Squibb (BMY) reported Q1 2025 financial results with total revenues of $11.2 billion, declining 6% year-over-year. The company's Growth Portfolio showed strong performance with revenues of $5.6 billion, increasing 16% (+18% Ex-FX), driven by Opdivo, Breyanzi, Reblozyl and Camzyos.

Key financial metrics include GAAP EPS of $1.20 and non-GAAP EPS of $1.80. The Legacy Portfolio revenues declined 20% to $5.6 billion due to generic impact on key products and U.S. Medicare Part D redesign effects.

BMY has raised its 2025 guidance, with revenue now expected between $45.8-$46.8 billion (previously ~$45.5 billion) and increased non-GAAP EPS guidance to $6.70-$7.00. The improved outlook reflects strong Growth Portfolio performance and better-than-expected Legacy Portfolio sales in Q1 2025.

Bristol Myers Squibb (NYSE: BMY) announced topline results from the Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia. The trial did not achieve statistical significance in its primary endpoint, showing only a 2.0-point reduction in the PANSS total score compared to placebo (P = 0.11).

Key findings include:

• Cobenfy demonstrated a -14.3 point change in PANSS Total Score vs -12.2 for placebo
• Post-hoc analysis revealed better responses in non-risperidone treated patients (-3.4 point difference, P = 0.03)
• Safety profile remained consistent with previous monotherapy trials

Despite not meeting the primary endpoint, the company plans to complete further analysis and discuss potential next steps with regulators. The clinical development program continues across multiple neuropsychiatric conditions, including Alzheimer's disease, autism spectrum disorder, and bipolar disorder.

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has updated the U.S. Prescribing Information for CAMZYOS®, their cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (oHCM). The key updates include:

• Reduced echo monitoring frequency from every 12 weeks to every 6 months for eligible maintenance phase patients
• Removal of contraindications for moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors
• Expanded patient eligibility with revised dosing and monitoring guidelines

These updates are supported by long-term clinical and real-world data from over 15,000 U.S. patients, including REMS Program analyses and three single-center studies showing safety through 3.5 years. CAMZYOS remains subject to a Boxed WARNING for heart failure risk and is only available through a restricted REMS program.

Optellum has partnered with Bristol Myers Squibb (NYSE: BMY) to enhance early lung cancer diagnosis using artificial intelligence. The collaboration focuses on implementing Optellum's Virtual Nodule Clinic (VNC), the first FDA-cleared AI-powered decision support tool for early-stage lung cancer.

The platform combines Patient Discovery AI and a clinically validated Lung Cancer Prediction score to analyze CT scans and identify at-risk patients. With 93 million CT scans conducted annually in the USA, the technology enables 'opportunistic screening' through automated AI-driven analysis.

Under the agreement, Optellum will deploy its VNC platform across multiple U.S. healthcare systems to assess real-world impact and generate evidence for AI implementation best practices. The initiative aims to address the challenge of late-stage lung cancer diagnosis, which currently limits treatment options and survival rates.

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.