Merck's oral PCSK9 inhibitor shows 55.8% LDL-C reduction in trial

Merck (MRK) announced positive Phase 3 trial results for its investigational once-daily oral PCSK9 inhibitor, enlicitide decanoate, demonstrating a 55.8% reduction in LDL-C compared to placebo at 24 weeks with a safety profile comparable to placebo. This potential first-in-class oral therapy could offer a significant alternative to existing injectable PCSK9 inhibitors, with Merck planning regulatory submissions. Concurrently, the company reported stronger-than-expected Q3 2025 earnings, with EPS of $2.58 and revenue of $17.28 billion, and further strengthened its pipeline through a $700 million funding deal with Blackstone Life Sciences for a cancer drug and the full acquisition of MK-8690 development rights.

Analysis

Merck announced robust Phase 3 results for its investigational oral PCSK9 inhibitor, enlicitide decanoate, demonstrating a 55.8% reduction in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo, with sustained reductions for one year. This data, presented at the American Heart Association Scientific Sessions 2025, highlights its potential as the first oral PCSK9 inhibitor, offering a significant alternative to current injectable therapies, and demonstrated a safety profile comparable to placebo with only 3.1% discontinuations due to adverse events. Merck plans to submit this data to regulatory authorities worldwide.

Concurrently, Merck reported stronger-than-expected Q3 2025 earnings, with earnings per share of $2.58 surpassing forecasts of $2.35, and revenue reaching $17.28 billion against an anticipated $16.98 billion. This financial outperformance is complemented by strategic pipeline advancements, including a $700 million funding deal with Blackstone Life Sciences for the cancer drug sacituzumab tirumotecan.

Further strengthening its R&D capabilities, Merck also secured full development control of MK-8690 with an upfront payment of $150 million. These developments underscore Merck's commitment to innovation and pipeline diversification across key therapeutic areas. InvestingPro analysts currently assess Merck as undervalued, suggesting potential upside given these positive operational and clinical developments.

Key Decisions for Investors

• Investors should closely monitor the regulatory progress of enlicitide decanoate, as its potential approval as the first oral PCSK9 inhibitor could significantly enhance Merck's market position and future revenue streams.
• Consider Merck's consistent financial outperformance, highlighted by the Q3 2025 earnings beat, and its strategic pipeline investments in oncology and other therapeutic areas, which support a positive long-term outlook.
• Evaluate the current 'undervalued' assessment by InvestingPro analysts in conjunction with these strong clinical and financial developments, which may present an attractive entry point for long-term capital appreciation.