FDA Priority Review for Opdivo Combo in Hodgkin Lymphoma Aligns with BMY's Growth Strategy but Offers Limited Upside

What happened

The U.S. FDA granted Priority Review to Bristol Myers Squibb's application for Opdivo plus chemotherapy in Classical Hodgkin Lymphoma, potentially expediting approval. This regulatory step supports BMY's focus on extending Opdivo's lifecycle, a core part of its Growth Portfolio that drove $6.6B in Q2 2025 revenue. However, from the DeepValue report, Opdivo faces stiff competition from Keytruda and Imfinzi, with label wins needed to counter patent cliffs and IRA pressures on Eliquis. Hodgkin Lymphoma is a niche indication, so the financial impact may be modest relative to broader oncology markets. Overall, this event reinforces BMY's innovation narrative but does not eliminate the need for robust execution on subcutaneous Opdivo and other pipeline assets.

Implication

First, the Priority Review could lead to a faster approval, enhancing BMY's ability to monetize Opdivo in a new setting. Second, it demonstrates regulatory momentum for the drug's lifecycle management, which is critical as the company navigates IRA headwinds and LOE pressures. Third, however, Hodgkin Lymphoma represents a small patient population, capping revenue potential and making this a minor catalyst in the broader portfolio. Fourth, investors should remain focused on key watch items from the report, such as subcutaneous Opdivo adoption and the Cobenfy launch, which have larger financial implications. Fifth, while positive, this news underscores the necessity for BMY to continue delivering on its Growth Portfolio to offset elevated leverage and competitive risks.

Thesis delta

The BUY thesis remains unchanged, as this news aligns with expected Opdivo lifecycle extensions and does not alter the fundamental risk-reward balance. However, it highlights the ongoing need for BMY to execute on label wins and pipeline diversification to mitigate looming challenges like IRA impacts on Eliquis.