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BMY Gets Opdivo Label Expansion in the EU, Update on Camzyos
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Key Takeaways
Bristol Myers won EU approval for Opdivo plus AVD in newly diagnosed advanced cHL patients.
Opdivo plus AVD cut progression or death risk by 58% versus brentuximab vedotin plus AVD.
BMY's Camzyos adolescent oHCM sNDA received FDA Priority Review with a Sept. 30, 2026 action date.
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has approved yet another label expansion of blockbuster immuno-oncology drug Opdivo (nivolumab).
The drug is now approved in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for the treatment of previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in adults and adolescents aged 12 years and older.
The decision makes Opdivo plus AVD the first immunotherapy-based regimen approved in the EU for newly diagnosed advanced cHL.
The EC’s decision was supported by data from the phase III SWOG 1826 study, in which Opdivo plus AVD reduced the risk of disease progression or death by 58% compared with brentuximab vedotin plus AVD. The study met its primary endpoint of progression-free survival, demonstrating a statistically significant benefit based on a median follow-up of 13.7 months.
After a median follow-up of 36.7 months, median overall survival had not been reached in either arm. The Opdivo plus AVD group recorded 9 deaths compared with 17 deaths in the brentuximab vedotin plus AVD arm.
The latest approval further expands Opdivo’s role in cHL. This approval follows the FDA approval granted in March 2026 forthe same indication.
Earlier this year, the EC also approved Opdivo in combination with brentuximab vedotin for pediatric, adolescent, and young adult patients with relapsed or refractory cHL after one prior line of therapy.
Opdivo is approved for several oncology indications including bladder, blood, colorectal carcinoma (CRC), head and neck, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), lung, melanoma, malignant pleural mesothelioma (MPM), stomach and esophageal cancer.
The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC and various gastric and esophageal cancers.
Opdivo sales came in at $2.15 billion, down 5% year over year with most of this decline coming from the United States due to inventory drawdown at the wholesaler level and continued conversion to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy injection for subcutaneous use).
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
BMY announced that the FDA has accepted a supplemental New Drug Application (sNDA) seeking approval of Camzyos (mavacamten) for the treatment of adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The FDA granted the application Priority Review and set a target action date of September 30, 2026. If approved, Camzyos would become the first cardiac myosin inhibitor (CMI) available for adolescents with oHCM.
Please note that Camzyos is currently approved in the United States for adults with symptomatic New York Heart Association (NYHA) class II-III oHCM to improve symptoms and functional capacity.
The sNDA is supported by results from the late-stage SCOUT-HCM study, which achieved its primary endpoint. The study demonstrated a statistically significant and clinically meaningful reduction in Valsalva left ventricular outflow tract gradient from baseline at week 28 in adolescents treated with Camzyos compared with placebo.
Camzyos also showed a safety profile consistent with that observed in adult patients with symptomatic oHCM.
Sales of the drug came in at $314 million in the first quarter. Approval of the drug for a wider population should boost sales.
BMY Looking to Diversify Portfolio Amid Legacy Drugs Decline
While drugs like Breyanzi, Reblozyl and Camzyos are driving top-line growth for BMY enabling it to offset generic competition for legacy drugs, the decline in Opdivo sales in the first quarter was disappointing.
Shares of the company have inched up 0.9% year to date compared with the industry’s growth of 2.2%.
Image Source: Zacks Investment Research
Concurrent with the first-quarter results reported in April, BMY highlighted the growing depth and diversification of its pipeline, with several pivotal phase III readouts expected in the second half of 2026, including milvexian in atrial fibrillation and secondary stroke prevention, Cobenfy in Alzheimer's disease psychosis, and iberdomide progression free survival data.
Positive outcomes from these programs could further de-risk the company's long-term growth outlook, expand its portfolio, and support its goal of launching more than 10 new drugs and 30 lifecycle expansion opportunities by the end of the decade.
Management also emphasized ongoing efforts to improve R&D productivity, streamline clinical development, and strengthen the early and mid-stage pipeline, positioning the company for sustained innovation and future revenue growth as its legacy portfolio continues to be adversely impacted by the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 62.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from a loss of 88 cents to earnings of 6 cents. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents per share. IMCR shares have lost 18.4% year to date.
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BMY Gets Opdivo Label Expansion in the EU, Update on Camzyos
Key Takeaways
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has approved yet another label expansion of blockbuster immuno-oncology drug Opdivo (nivolumab).
The drug is now approved in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for the treatment of previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in adults and adolescents aged 12 years and older.
The decision makes Opdivo plus AVD the first immunotherapy-based regimen approved in the EU for newly diagnosed advanced cHL.
The EC’s decision was supported by data from the phase III SWOG 1826 study, in which Opdivo plus AVD reduced the risk of disease progression or death by 58% compared with brentuximab vedotin plus AVD. The study met its primary endpoint of progression-free survival, demonstrating a statistically significant benefit based on a median follow-up of 13.7 months.
After a median follow-up of 36.7 months, median overall survival had not been reached in either arm. The Opdivo plus AVD group recorded 9 deaths compared with 17 deaths in the brentuximab vedotin plus AVD arm.
The latest approval further expands Opdivo’s role in cHL. This approval follows the FDA approval granted in March 2026 forthe same indication.
Earlier this year, the EC also approved Opdivo in combination with brentuximab vedotin for pediatric, adolescent, and young adult patients with relapsed or refractory cHL after one prior line of therapy.
Opdivo is approved for several oncology indications including bladder, blood, colorectal carcinoma (CRC), head and neck, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), lung, melanoma, malignant pleural mesothelioma (MPM), stomach and esophageal cancer.
The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC and various gastric and esophageal cancers.
Opdivo sales came in at $2.15 billion, down 5% year over year with most of this decline coming from the United States due to inventory drawdown at the wholesaler level and continued conversion to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy injection for subcutaneous use).
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Bristol Myers Squibb Company price-consensus-eps-surprise-chart | Bristol Myers Squibb Company Quote
Update on BMY’s sNDA on Camzyos
BMY announced that the FDA has accepted a supplemental New Drug Application (sNDA) seeking approval of Camzyos (mavacamten) for the treatment of adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The FDA granted the application Priority Review and set a target action date of September 30, 2026. If approved, Camzyos would become the first cardiac myosin inhibitor (CMI) available for adolescents with oHCM.
Please note that Camzyos is currently approved in the United States for adults with symptomatic New York Heart Association (NYHA) class II-III oHCM to improve symptoms and functional capacity.
The sNDA is supported by results from the late-stage SCOUT-HCM study, which achieved its primary endpoint. The study demonstrated a statistically significant and clinically meaningful reduction in Valsalva left ventricular outflow tract gradient from baseline at week 28 in adolescents treated with Camzyos compared with placebo.
Camzyos also showed a safety profile consistent with that observed in adult patients with symptomatic oHCM.
Sales of the drug came in at $314 million in the first quarter. Approval of the drug for a wider population should boost sales.
BMY Looking to Diversify Portfolio Amid Legacy Drugs Decline
While drugs like Breyanzi, Reblozyl and Camzyos are driving top-line growth for BMY enabling it to offset generic competition for legacy drugs, the decline in Opdivo sales in the first quarter was disappointing.
Shares of the company have inched up 0.9% year to date compared with the industry’s growth of 2.2%.
Image Source: Zacks Investment Research
Concurrent with the first-quarter results reported in April, BMY highlighted the growing depth and diversification of its pipeline, with several pivotal phase III readouts expected in the second half of 2026, including milvexian in atrial fibrillation and secondary stroke prevention, Cobenfy in Alzheimer's disease psychosis, and iberdomide progression free survival data.
Positive outcomes from these programs could further de-risk the company's long-term growth outlook, expand its portfolio, and support its goal of launching more than 10 new drugs and 30 lifecycle expansion opportunities by the end of the decade.
Management also emphasized ongoing efforts to improve R&D productivity, streamline clinical development, and strengthen the early and mid-stage pipeline, positioning the company for sustained innovation and future revenue growth as its legacy portfolio continues to be adversely impacted by the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY’s Zacks Rank & Key Picks
BMY currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 62.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from a loss of 88 cents to earnings of 6 cents. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents per share. IMCR shares have lost 18.4% year to date.