Merck's Keytruda SC Nears EU Approval with Potential Upside of 21.98%

Merck's Keytruda SC is set to receive EU approval, expanding its cancer treatment portfolio and potentially boosting its stock. Analyst projections suggest a 21.98% upside from the current price of $81.53, while GuruFocus estimates indicate a 51.34% potential growth in the coming year. Merck aims to increase accessibility and market presence ahead of Keytruda's patent expiration.

Merck & Co. Inc. (MRK) is on the cusp of expanding its cancer treatment portfolio in Europe with the impending approval of Keytruda SC. The European Medicines Agency (EMA) has given a positive nod to the new subcutaneous (SC) formulation of Keytruda, with final approval from the European Commission expected by late 2025 Merck's (MRK) Keytruda SC Nears EU Approval^[1].

Keytruda SC is an innovative injectable variant of Merck's flagship cancer treatment, pembrolizumab. If approved, it will offer a shorter administration time compared to the current intravenous infusion, providing more treatment options for patients. This new formulation is expected to be administered in one minute every three weeks or in two minutes every six weeks Merck Receives Two Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab), for Subcutaneous (SC) Administration and for New Indication for Earlier-Stage Head and Neck Cancer^[2].

The approval of Keytruda SC aligns with Merck's strategic move to bolster its market presence and increase accessibility ahead of the drug's patent expiration. The company is committed to driving innovation in cancer care and making its therapies more accessible to patients.

Analyst projections suggest a significant upside potential for Merck's stock. A one-year average price target of $99.45 has been projected by 24 leading analysts, with estimates ranging from a high of $141.00 to a low of $82.00. This average target offers a notable 21.98% upside from the current trading price of $81.53 Merck's (MRK) Keytruda SC Nears EU Approval^[1].

GuruFocus estimates indicate a remarkable potential growth for Merck in the coming year, with the GF Value estimate predicting a value of $123.39 within the next year. This suggests a 51.34% upside potential from the current market price of $81.53 Merck's (MRK) Keytruda SC Nears EU Approval^[1].

In addition to Keytruda SC, Merck has received two positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Keytruda as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 Merck Receives Two Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab), for Subcutaneous (SC) Administration and for New Indication for Earlier-Stage Head and Neck Cancer^[2].

The approval of these new indications and formulations is part of Merck's broader strategy to advance its early-stage cancer clinical program and bring its therapies to more patients.