By Chris Wack
INmune Bio Inc. shares were down 24% to $5.51 after the company said the Food and Drug Administration requested additional information for chemistry manufacturing and controls of the newly manufactured XPro1595.
The stock hit its 52-week low of $4.63 earlier in the session.
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.
B. Riley Securities cut its ratings for INmune shares to neutral from buy, while cutting its price target to $7 from $14 a share. BTIG cut its price target to $14 from $31 a share, while maintaining its buy rating on the stock.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires