European Commission approves Opdivo subcutaneous form

PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY), a prominent player in the pharmaceuticals industry with annual revenue of $47.64 billion, has received approval from the European Commission (EC) for a new subcutaneous (SC) formulation of Opdivo (nivolumab), marking a significant advancement in the administration of cancer treatments. According to InvestingPro analysis, BMY maintains a strong financial health score of 2.95 (GOOD), supporting its continued innovation in the healthcare sector. The EC’s endorsement hinges on the Phase 3 CheckMate -67T trial results, which confirmed the noninferiority of the SC formulation to the intravenous (IV) version in terms of pharmacokinetics and safety profiles.

The new SC formulation, co-formulated with recombinant human hyaluronidase (rHuPH20), is now approved for use in adult patients across various solid tumors. This includes as a monotherapy, a maintenance therapy post IV nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. With an EBITDA of $19.17 billion and a substantial dividend yield of 5.29%, BMY demonstrates strong financial fundamentals that support its ongoing product development initiatives. Discover more detailed insights about BMY’s financial performance and growth potential with a InvestingPro subscription, which includes access to comprehensive Pro Research Reports covering 1,400+ top stocks.

Dana Walker, M.D., M.S.C.E., the global program lead for Opdivo at Bristol Myers Squibb, highlighted the convenience of the 3- to 5-minute SC injection compared to the IV form, which has been influential in cancer treatment for over a decade. The approval is expected to enhance the patient experience by offering a more efficient administration method.

The CheckMate -67T trial demonstrated that Opdivo SC’s pharmacokinetics, with time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady state (Cminss), were noninferior to IV Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The trial also showed a comparable efficacy profile, with an objective response rate (ORR) of 24% in the Opdivo SC arm versus 18% in the IV Opdivo arm.

Laurence Albiges, M.D., Ph.D., from Université Paris-Saclay, expressed that the approval of SC nivolumab transforms the treatment landscape by providing a new administration method that potentially offers the same benefits as the IV formulation.

The EC approval applies to all EU member states, as well as Iceland, Liechtenstein, and Norway. Additionally, on December 27, 2024, the U.S. Food and Drug Administration (FDA) approved the SC formulation of nivolumab, marketed as Opdivo QvantigTM.

Bristol Myers Squibb has recognized the patients and investigators involved in the CheckMate -67T clinical trial and remains committed to advancing treatments that improve patient experiences. This approval further solidifies the company’s dedication to providing innovative solutions in cancer care. InvestingPro analysis indicates that BMY’s net income is expected to grow this year, with analysts predicting continued profitability. The company’s strong market position is further evidenced by its impressive gross profit margin of 74.69% and consistent dividend payments maintained for 55 consecutive years.

Information for this article is based on a press release statement from Bristol Myers Squibb.

In other recent news, Bristol Myers Squibb reported impressive financial results for the first quarter of 2025, surpassing analysts’ expectations. The company’s earnings per share (EPS) reached $1.80, outperforming the forecasted $1.52, while revenue climbed to $11.2 billion, exceeding the anticipated $10.68 billion. This strong performance prompted Bristol Myers Squibb to raise its full-year revenue guidance to a range of $45.8 billion to $46.8 billion. In leadership news, the company appointed Cari Gallman as the new Executive Vice President, General Counsel, and Chief Policy Officer. Gallman takes over from Sandra Leung, who retired after 33 years with the company.

Additionally, BofA Securities updated its outlook on Bristol Myers Squibb, increasing the stock price target to $56 while maintaining a Neutral rating. The firm noted the company’s valuation is in line with its peers, though it faces challenges from generic competition. In corporate developments, Bristol Myers Squibb continues to focus on its strategic priorities, including the advancement of its oncology pipeline and the successful launch of new products like COBENFY for schizophrenia. These efforts underscore the company’s commitment to maintaining a competitive edge in the pharmaceutical industry.

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