Merck & Co. stock gains on positive efinopegdutide Phase 2b data

Merck & Co. reported positive Phase 2b results for its investigational efinopegdutide in adults with metabolic dysfunction-associated steatohepatitis and stage F2 or F3 liver fibrosis. In a release dated November 9, the company said the findings were presented at The Liver Meeting and published in The Lancet. Merck said the study met its primary efficacy endpoint.

Merck & Co. stock traded at 133.69 euros on Lang & Schwarz at 13:43 CET on Thursday, November 12, 1.73 percent above the Xetra close of Wednesday, November 11. The comparison close was 131.42 euros.

Trial results support development case

The MK-6024-013 trial tested once-weekly subcutaneous efinopegdutide at 4 mg, 7 mg and 10 mg against placebo, with an open-label semaglutide 2.4 mg reference arm. Among participants receiving efinopegdutide, MASH resolution without worsening of fibrosis was recorded in 56%, 63% and 61% of cases, respectively, compared with 13% for placebo. All three dose groups achieved statistical significance, with p-values below 0.0001.

The key secondary fibrosis endpoint also favored the candidate. Improvement of at least one fibrosis stage without worsening of steatohepatitis reached 43% in the 4 mg group, 52% in the 7 mg group and 34% in the 10 mg group, versus 21% with placebo.

Safety remains part of the assessment

The safety profile was generally consistent with semaglutide, according to Merck. Nausea occurred in 29%, 39% and 44% of patients across the three efinopegdutide doses, compared with 39% for semaglutide and 11% for placebo. Discontinuations because of adverse events were 3%, 4% and 11%, versus 1% in both the semaglutide and placebo groups.

The trial enrolled 386 adults, of whom 381 were randomized and received at least one dose; 92% completed the study. Efinopegdutide is being developed under an exclusive licensing agreement with Hanmi Pharmaceutical and has received Fast Track designation from the U.S. Food and Drug Administration. The designation can support regulatory interaction but does not guarantee approval or commercial success.

Pipeline relevance for investors

The results add a potential cardiometabolic growth asset to Merck's broader pharmaceutical pipeline. For investors, the data provide clinical support for further development, while the investigational status and the need for later regulatory steps keep execution and trial risk central to the investment case.

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