By Chris Wack

 

INmune Bio Inc. shares were down 28% to $5.20 in premarket trading Tuesday after the company said the U.S. Food and Drug Administration requested additional information for chemistry manufacturing and controls of the newly manufactured XPro1595.

The company said that as part of the communication, the agency placed its investigational new drug application to initiate its Phase 2 clinical trial of XPro in patients with Alzheimer's Disease in the U.S. on clinical hold.

The FDA indicated it will provide an official clinical hold letter to INmune in about 30 days, the company said.

INmune said it plans to provide additional updates pending discussion with the FDA, and its Phase 2 trial of XPro remains open in Australia and continues to enroll patients.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

May 24, 2022 08:05 ET (12:05 GMT)

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