- The stock price of Finch Therapeutics Group Inc (NASDAQ: FNCH) increased by over 40% pre-market today. This is why.
The stock price of Finch Therapeutics Group Inc (NASDAQ: FNCH) – a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs – increased by over 40% pre-market today. Investors are responding positively to Finch Therapeutics announcing that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) 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 (CDI). And the FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.
Finch 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. And the PRISM4 protocol amendment will implement changes to the algorithm used to diagnose suspected CDI recurrences and revisions to the planned statistical analysis. In parallel with these activities, Finch will continue to work with its PRISM4 trial sites to prepare for enrollment.
Finch is planning to provide an update on the anticipated timing of both its PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms when the company reports its first quarter 2022 results.
“We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted. We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
— Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics
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