secwatch.observer — SEC 8-K summary
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Issuer:     Finch Therapeutics Group, Inc. (FNCHQ)
CIK:        0001733257
Form:       8-K
Filed at:   2022-03-01T23:59:59+00:00
Accession:  0001193125-22-061539
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/0001193125-22-061539-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/d292195d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-061539

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer