Will the Recent Label Expansion of BMY's Opdivo Boost Its IO Franchise?

Bristol Myers Squibb BMY recently won FDA and European Commission (EC) approvals for the label expansion of its blockbuster immuno-oncology (IO) drug Opdivo.

The FDA approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, stage III or IV cHL.

The EC approved Opdivo in combination with brentuximab vedotin for select pediatric and young adult patients with relapsed or refractory cHL following prior therapy.

These label expansions broaden Opdivo’s addressable market across both frontline and relapsed settings, enhance its competitive positioning in hematologic malignancies, and support long-term growth potential within Bristol Myers Squibb’s oncology portfolio.

We note that Opdivo is already indicated for the treatment of adult patients with cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication was approved under accelerated approval based on the overall response rate.

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 is also approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC, and various gastric and esophageal cancers.

Opdivo raked in sales of $10 billion in 2025, up 8% year over year, driven by recent launches in MSI-high CRC, HCC and strength in first-line NSCLC market.

BMY has built a strong IO foundation with Opdivo, Yervoy and Opdualag.

Opdualag (nivolumab and relatlimab-rmbw) is a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Sales of this drug totaled $1.18 billion in 2025, driven by continued demand as a standard of care in first-line melanoma.

The FDA approval of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use has strengthened its IO franchise. Per BMY, this new subcutaneous formulation of Opdivo should help extend the reach and impact of its IO franchise to patients into the next decade.

The successful development of all late-stage pipeline candidates and label expansion of approved drugs should be a significant boost for BMY as its legacy portfolio continues to be adversely impacted by the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.

BMY’s Competition in Oncology Space

Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space.

The company competes with big pharma giants Merck MRK and Pfizer PFE in this space.

The IO space is dominated by pharma giant MRK’s blockbuster drug Keytruda (pembrolizumab).

Keytruda is approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.

Developing bispecific antibodies that target two proteins, namely PD-1 and VEGF, has lately been one of the lucrative areas in cancer treatment.

In 2024, pharma giant Merck received an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova. Merck’s oncology portfolio boasts a blockbuster PD-L1 inhibitor, Keytruda, and the company is looking to build a diversified oncology pipeline spanning differentiated mechanisms and multiple modalities.

Pfizer is one of the largest and most successful drugmakers in the field of oncology. It has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immunotherapies that treat a wide range of cancers, including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and lung cancer. Pfizer also has oncology biosimilars in its portfolio.

The company inked a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, outside China.

Pfizer is also advancing a robust pipeline of oncology candidates, with several entering late-stage development.

BMY’s Price Performance, Valuation & Estimates

Shares of Bristol Myers have surged 32.2% in the past six months compared with the industry’s growth of 14.7%.

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From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, the stock currently trades at 9.23x forward earnings, higher than its mean of 7.66x but lower than the large-cap pharma industry’s 16.75x.

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The Zacks Consensus Estimate for 2026 EPS has moved north to $6.26 from $6.19 in the past 30 days, while that for 2027 has increased to $6.09 from $5.97.

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BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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