BMY Secures European Approval for Breyanzi Label Expansion in MCL, Reinforcing Growth Portfolio

What happened

Bristol Myers Squibb has gained European Commission approval to expand the label of its CAR T cell therapy Breyanzi to include mantle cell lymphoma (MCL) patients, adding to its European indications. This development aligns with the company's strategy to bolster its Growth Portfolio, which delivered $6.6 billion in Q2 2025 revenue and is central to the raised FY2025 guidance. The expansion could drive modest revenue growth in Europe by tapping into a new patient population, leveraging BMY's scaled CAR-T manufacturing and commercialization efforts. However, the impact may be limited by the small addressable market for MCL and intense competition in the cell therapy space, which includes rivals like Gilead and Novartis. Overall, this regulatory win supports ongoing execution but does not fundamentally alter the investment thesis focused on offsetting patent cliffs and IRA pressures.

Implication

Investors should see this as a positive, incremental step that validates BMY's ability to execute on regulatory milestones and expand its cell therapy footprint, potentially contributing low single-digit revenue growth. It reinforces the Growth Portfolio's momentum, a key watch item in the DeepValue report, which could help offset ongoing losses from products like Revlimid. However, the financial impact is likely small relative to BMY's $47 billion revenue base and does not address core vulnerabilities such as the 2026 Eliquis price negotiations or elevated net debt-to-EBITDA of 12.9x. The approval also fails to mitigate risks from competitive pressures in oncology or supply chain constraints in radiopharma. Consequently, while supportive, this event underscores the need for continued monitoring of broader portfolio execution and deleveraging progress to sustain the BUY thesis.

Thesis delta

The European label expansion for Breyanzi incrementally strengthens the Growth Portfolio narrative, aligning with BMY's focus on innovation and execution highlighted in the DeepValue report. However, it does not shift the core thesis, which remains contingent on managing Eliquis IRA impacts, scaling launches like Cobenfy, and reducing leverage, as these factors pose greater risks to earnings and valuation.