By Joshua Kirby

Shares in Germany's Merck KGaA slipped Wednesday after the company said U.S. authorities have enforced a pause on initiating new patients in a drug trial.

The study will continue with its current participants as planned, the drugmaker said.

The U.S. Food & Drug Administration, or FDA, placed the partial clinical hold on the initiation of new patients in the Phase 3 study of evobrutinib, Merck KGaA said.

The hold also applies to patients with less than 70 days' exposure to evobrutinib, which is being developed by Merck KGaA as a potential treatment for relapsing multiple sclerosis.

At 0718 GMT, shares were trading 5.1% down at EUR164.10.

The pause follows two cases of apparent drug-induced liver injury identified during the study, Merck KGaA said. Both patients were asymptomatic and required no medical intervention or hospitalization, the company said.

The study will continue as planned, with all participants to remain on the treatment and results expected in the fourth quarter this year, Merck KGaA said.

"Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib," the company said.

Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby

(END) Dow Jones Newswires

April 12, 2023 03:39 ET (07:39 GMT)

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