By Chris Wack

 

Finch Therapeutics Group Inc. shares rose 44% to $3.04 after the company said the U.S. Food and Drug Administration removed the clinical hold on a investigational new drug application for CP101.

CP101 is the company's investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection.

The FDA lifted the hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.

Finch said it expects to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality system updates related to the recently resolved clinical hold, and submits for the FDA's review and agreement the validation package for one of its release tests and a PRISM4 protocol amendment.

 

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

 

(END) Dow Jones Newswires

April 29, 2022 10:29 ET (14:29 GMT)

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