Merck & Co., Inc. (MRK) Stock: European Union Approves Subcutaneous Keytruda

TLDR

• EU approves subcutaneous Keytruda for all adult indications.
• New injection offers one-minute or two-minute dosing.
• Trial shows comparable results to IV Keytruda in NSCLC.
• Approval covers all 27 EU states plus Iceland, Liechtenstein and Norway.
• Merck stock trades at $96.43 as investors gauge expansion impact.

Merck & Co., Inc. (MRK), trading at $96.43 at Wednesday’s close, received a major regulatory boost as the European Commission approved the company’s subcutaneous version of Keytruda for all adult indications already cleared in the European Union.

Merck & Co., Inc., MRK

The decision adds momentum ahead of Merck’s upcoming earnings expected in late January 2026 and arrives during a year marked by modest stock performance, with MRK showing a –0.27% YTD return compared with the S&P 500’s 12.51% gain.

EC Grants Full Approval for Keytruda SC

The European Commission authorized KEYTRUDA SC, a subcutaneous formulation of pembrolizumab combined with berahyaluronidase alfa, enabling rapid administration directly under the skin. The injection will be marketed as Keytruda SC in Europe and as Keytruda QLEX in the United States.

With this approval, patients across all 33 Keytruda adult indications gain access to a faster, more flexible dosing option. The product is the first subcutaneous immune checkpoint inhibitor available in the EU.

Dr. Marjorie Green, senior vice president of oncology at Merck Research Laboratories, said the formulation can be delivered in one minute every three weeks or two minutes every six weeks, reducing chair time and increasing patient convenience.

Key Trial Supports Approval

The approval is based on the pivotal 3475A-D77 trial, which compared subcutaneous Keytruda and the traditional IV formulation in patients newly diagnosed with metastatic non-small cell lung cancer lacking EGFR, ALK or ROS1 tumor aberrations.

Both treatments were administered every six weeks with chemotherapy. Results showed comparable pharmacokinetic exposure between the two formulations.

• The overall response rate for the Keytruda SC arm reached 45% (95% CI, 39–52).
• The IV Keytruda arm reported a 42% response rate (95% CI, 33–51).

No meaningful differences were observed in progression-free survival or overall survival.

Rollout Across the EU

The EC decision allows marketing across all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Actual country-level availability will depend on reimbursement timelines and national regulatory procedures.

The ruling follows a positive recommendation from the CHMP in September 2025, the same month the FDA approved the U.S. version, Keytruda QLEX.

Merck’s Stock Performance Context

Merck shares have delivered steady but moderate gains over the past five years:

• 1-year return: 3.56%
• 3-year return: 1.18%
• 5-year return: 47.50%

The company continues to rely on Keytruda’s expanding portfolio to maintain long-term revenue growth as regulatory progress strengthens its oncology leadership.

The EC approval marks a significant step for Merck’s patient-centric innovation strategy, enhancing treatment accessibility across Europe.

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