Bristol-Myers Squibb Co - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) announced significant final analysis results from the Phase 3 CheckMate -816 study of Opdivo® (nivolumab) combined with platinum-doublet chemotherapy for resectable non-small cell lung cancer (NSCLC). The study demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, compared to neoadjuvant chemotherapy alone.

The results build upon previously reported successful primary endpoints of event-free survival (EFS) and pathological complete response (pCR). The safety profile remained consistent with previous studies, showing no new safety signals. This marks Opdivo as the first and only neoadjuvant-only immuno-oncology therapy to show statistically significant benefit in resectable NSCLC patients.

Bristol Myers Squibb (NYSE:BMY) announced new five-year results from the POETYK PSO long-term extension trial of Sotyktu (deucravacitinib) in treating moderate-to-severe plaque psoriasis. The study demonstrated consistent safety profile with no new safety signals after more than 5,000 patient-years of exposure.

The trial showed maintained clinical response rates from Year 1 to Year 5, with efficacy outcomes for continuously treated patients showing: PASI 75 (72.1% Year 1; 67.3% Year 5), PASI 90 (45.9% Year 1; 46.3% Year 5), and sPGA 0/1 (57.5% Year 1; 52.6% Year 5). The efficacy analysis included 513 patients who received continuous treatment, while the safety analysis covered 1,519 patients who received at least one dose during the trials.

Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 RELATIVITY-098 trial for Opdualag in adjuvant treatment of completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile remained consistent with known profiles of nivolumab and relatlimab.

Despite this setback, Opdualag continues to be a standard of care in first-line treatment of unresectable or metastatic melanoma. The company is exploring its potential across other tumor types, including non-small cell lung cancer. For adjuvant melanoma, Opdivo remains a standard of care for patients 12 years and older with completely resected Stage IIB, IIC, III, or IV melanoma.

Additionally, Opdivo Qvantig was recently approved in the U.S. as a subcutaneous option for adjuvant treatment in adult patients with completely resected Stage IIB, IIC, III, or IV melanoma.

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.