BMY's Opdivo SC Gets EU Nod for Multiple Solid Tumor Indications

Bristol Myers BMY announced that the European Commission (EC) has approved the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumor indications. The decision applies to all 27 EU member states, as well as Iceland, Norway and Liechtenstein.

Nivolumab for subcutaneous (SC) use, co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

The EC nod makes Opdivo the first and only PD-1 inhibitor approved for subcutaneous use in the EU. Please note that the SC nivolumab and hyaluronidase-nvhy combination is already approved in the United States under the brand name Opdivo Qvantig.

Shares of Bristol Myers have lost 17% year to date compared with the industry’s 5.4% decline.

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More on the EU Approval of Subcutaneous Opdivo

The EC’s positive decision regarding the approval of Opdivo SC across multiple solid tumor indications was supported by findings from Bristol Myers’ CheckMate -67T clinical study and supplementary data.

Per the data readout, the SC formulation of Opdivo showed a pharmacokinetics and safety profile comparable to the intravenous (IV) version. The CheckMate -67T study enrolled adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received up to two prior systemic therapies but no prior immuno-oncology treatment.

In the study, Bristol Myers’ Opdivo SC met the primary pharmacokinetic noninferiority endpoints — Cavgd28 and Cminss — compared to IV Opdivo. The geometric mean ratio for Cavgd28 was 2.10 and for Cminss, it was 1.77. Additionally, a key secondary endpoint showed that the objective response rate was 24% in the SC group and 18% in the IV group, supporting the SC formulation’s comparable efficacy. The safety profile of Opdivo SC was also consistent with that of the IV formulation.

Please note that Bristol Myers’ Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a range of cancer indications in many countries, including the United States and the EU.

Bristol Myers Squibb Company Price and Consensus

Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote

BMY’s Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Bayer BAYRY, Lexicon Pharmaceuticals LXRX and Amarin AMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.2%. 

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 

In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 5.3%.

LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.

In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.33 to $3.48. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 16.4%.

AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.

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