---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-061539"
form_type: "8-K"
ticker: "FNCHQ"
cik: "0001733257"
company_name: "Finch Therapeutics Group, Inc."
filed_at: "2022-03-01T23:59:59+00:00"
generated_at: "2026-06-27T03:06:38.976682+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Finch Therapeutics pauses Phase 3 PRISM4 trial; FDA clinical hold on CP101; dosing occurred while hold in effect

## Summary
- FDA clinical hold letter Feb 24, 2022 requesting additional info on SARS-CoV-2 donor screening protocols.
- Company paused enrollment in PRISM4 Phase 3 trial of CP101 for recurrent C. difficile infection.
- Company informed FDA that participants were dosed while clinical hold was in effect; conducting a review of the matter.
- FDA letter did not reference any adverse clinical outcomes in Finch's trials.
- Company evaluating impact on timing of expected topline data readout from PRISM4.

## SEC filing metadata
- accession: 0001193125-22-061539
- form_type: 8-K
- ticker: FNCHQ
- cik: 0001733257
- company_name: Finch Therapeutics Group, Inc.
- filed_at: 2022-03-01T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/0001193125-22-061539-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/d292195d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-061539
- JSON: https://secwatch.observer/filing/0001193125-22-061539.json
- Plain text: https://secwatch.observer/filing/0001193125-22-061539.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.