Viking Therapeutics Down After FDA Clinical Hold

By Michael Dabaie

Viking Therapeutics Inc. shares were down 8.3% to $3.50 in morning trading after the company said the U.S. Food and Drug Administration placed a clinical hold its trial of VK0214 in rare metabolic disorder X-linked adrenoleukodystrophy.

The company was recently informed the FDA considers the ongoing trial to be a Phase 2 trial rather than a Phase 1b. As a Phase 2 trial, a rodent genotoxicity study is required prior to continuation. Viking said it expects to provide the information to the FDA in the second quarter.

"The current request is in keeping with industry guidance for Phase 2 studies and is not based on data from previously submitted or ongoing studies. We are confident in the overall safety and potential efficacy profile of VK0214 and expect to submit a response with a goal to resume dosing in the study later this year," Chief Executive Brian Lian said.

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(END) Dow Jones Newswires

01-24-22 1055ET