Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE: BMY) announced positive Phase 2 TRANSCEND FL trial results for Breyanzi in treating adult patients with relapsed or refractory marginal zone lymphoma (MZL). The trial met its primary endpoint of overall response rate (ORR) and key secondary endpoint of complete response rate (CRR).

This marks the fifth cancer type where Breyanzi has shown clinically meaningful benefit, representing the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy. The treatment demonstrated durable responses and maintained a consistent safety profile with no new safety signals observed.

MZL is the second most common form of non-Hodgkin lymphoma, accounting for about 7% of all NHL cases. While initial therapy often leads to long remissions, relapse is common and can occur multiple times over many years.

Bristol Myers Squibb (BMY) reported Q4 2024 revenues of $12.3 billion, up 8% year-over-year, with Growth Portfolio revenues reaching $6.4 billion (+21%). Full-year 2024 revenues were $48.3 billion, increasing 7%.

Q4 GAAP EPS was $0.04 (down 95%) and non-GAAP EPS was $1.67 (down 2%). Full-year results showed a GAAP loss per share of $(4.41) and non-GAAP EPS of $1.15, including a $(6.39) per share impact from acquired IPRD charges.

The company expanded its strategic productivity initiative, targeting ~$2 billion in additional cost savings by end of 2027. For 2025, BMY guides revenues of ~$45.5 billion with non-GAAP EPS range of $6.55-$6.85.

Key achievements include U.S. approval of Opdivo Qvantig and launch of Cobenfy for schizophrenia treatment. Growth Portfolio performance was driven by higher demand for Reblozyl, Breyanzi, Camzyos, Yervoy and Opdualag.

Bristol Myers Squibb (BMY) received a positive CHMP opinion recommending approval of Opdivo plus Yervoy for first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). The recommendation is based on the Phase 3 CheckMate -9DW trial results, which demonstrated significant improvement in overall survival.

Key trial results showed median overall survival of 23.7 months for Opdivo plus Yervoy compared to 20.6 months with lenvatinib or sorafenib (HR: 0.79; p=0.018). The safety profile remained consistent with previous data and was manageable with established protocols.

The U.S. FDA has accepted BMY's supplemental Biologics License Application for this treatment with a PDUFA date of April 21, 2025. The combination already has accelerated approval in the U.S. as a second-line treatment based on Phase 2 CheckMate -040 trial results.

Bristol Myers Squibb (BMY) announced significant results from the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy versus Opdivo monotherapy in treating microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer.

Key findings at 47 months median follow-up include:

• 38% reduction in risk of disease progression or death with combination therapy
• Higher progression-free survival rates at 12, 24, and 36 months (76%, 71%, 68%) compared to monotherapy (63%, 56%, 51%)
• Significantly higher overall response rate (71% vs 58%)

The safety profile remained consistent with previous data, with Grade 3/4 treatment-related adverse events reported in 22% of combination therapy patients versus 14% with monotherapy. The study previously showed the combination reduced disease progression risk by 79% compared to chemotherapy.

Bristol Myers Squibb (NYSE: BMY) has announced its upcoming participation at J.P. Morgan's 43rd Annual Healthcare Conference. The presentation is scheduled for Monday, January 13, 2025, beginning at 7:30 a.m. PT/10:30 a.m. ET.

The event will feature a company presentation and fireside chat, which will be accessible through a simultaneous webcast at investor.bms.com. Presentation materials will be made available at the start of the live webcast. Following the event's conclusion, both a replay and archived version of the presentation will be accessible to viewers.

Bristol Myers Squibb (NYSE: BMY) received FDA approval for Opdivo Qvantig™, the first subcutaneously administered PD-1 inhibitor. This new formulation combines nivolumab with recombinant human hyaluronidase for most previously approved adult solid tumor Opdivo indications.

The approval is based on the Phase 3 CheckMate-67T trial results, which demonstrated non-inferior pharmacokinetics, similar efficacy in overall response rate (24% vs 18%), and comparable safety to intravenous Opdivo. A key advantage is the faster administration time of 3-5 minutes compared to 30-minute IV infusion.

The subcutaneous delivery method may offer greater flexibility for treatment location and reduced preparation time, potentially allowing patients to receive treatment closer to home.

Bristol Myers Squibb (NYSE: BMY) announced positive results from two pivotal Phase 3 trials, POETYK PsA-1 and POETYK PsA-2, evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. Both trials met their primary endpoint, with significantly more Sotyktu-treated patients achieving ACR20 response (20% improvement in disease symptoms) after 16 weeks compared to placebo.

The trials also met important secondary endpoints across PsA disease activity at Week 16. The safety profile remained consistent with previous Phase 2 PsA and Phase 3 plaque psoriasis trials. These results represent the first Phase 3 trials for Sotyktu in a rheumatic condition, with the drug already approved globally for moderate-to-severe plaque psoriasis treatment.

Bristol Myers Squibb (BMY) has received European Commission approval for Opdivo plus Yervoy as first-line treatment for adult patients with MSI-H/dMMR metastatic colorectal cancer. The approval is based on the Phase 3 CheckMate -8HW trial results, which showed the dual immunotherapy combination reduced disease progression or death risk by 79% compared to chemotherapy.

The trial demonstrated significant progression-free survival (PFS) benefits, with median PFS not yet reached for Opdivo plus Yervoy versus 5.9 months for chemotherapy. The safety profile remained consistent with previous data, showing Grade 3/4 treatment-related adverse events in 23% of patients in the combination arm versus 48% in the chemotherapy arm.

Bristol Myers Squibb (NYSE: BMY) has announced it will release its fourth quarter 2024 financial results on Thursday, February 6, 2025. The company will host a conference call and live webcast at 8:00 a.m. ET on the same day, where executives will review financial results and address questions from investors and analysts.

Investors and the public can participate through a live webcast at investor.bms.com or by registering for the conference call. Those unable to register can dial 1-833-816-1116 (U.S. toll-free) or +1 412-317-0705 (international). A replay will be available until February 20, 2025.