What happened
Shares of Finch Therapeutics Group (FNCH -8.47%) were skyrocketing 35.7% higher as of 11:32 a.m. ET on Friday. The huge gain came after the company announced that the U.S. Food and Drug Administration (FDA) has removed a clinical hold on the investigational new drug (IND) application for CP101. Finch Therapeutics is evaluating the experimental drug in preventing recurrent C. difficile infection (CDI).
So what
Finch Therapeutics and the FDA have gone back and forth for a while about SARS-CoV-2 screening protocols with the clinical testing of CP101. The agency first placed a partial clinical hold on the CP101 program in 2020.
The clinical hold was like a dark cloud hovering over Finch. The biotech stock had fallen more than 80% from its peak over the past 12 months prior to today's news.
Image source: Getty Images.
Now what
Finch Therapeutics now plans to move forward with patient enrollment in its Prism4 phase 3 clinical study of CP101 in recurrent CDI. However, it must first complete manufacturing activities and quality system updates connected with the resolution of the clinical hold. Finch also must submit additional documentation to the FDA before proceeding with enrollment in the study.
The company expects to provide an update on the timing for this clinical trial when it reports first-quarter results in a couple of months. Finch also intends to give an update at that time on its planned Auspire phase 1b clinical study evaluating FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms.