secwatch.observer — SEC 8-K summary
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Issuer:     Finch Therapeutics Group, Inc. (FNCHQ)
CIK:        0001733257
Form:       8-K
Filed at:   2022-04-28T23:59:59+00:00
Accession:  0000950170-22-006581
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Finch Therapeutics announces FDA removal of clinical hold on CP101 IND; prepares to resume PRISM4 Phase 3 trial
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- FDA lifted clinical hold on CP101 IND after Finch provided SARS-CoV-2 screening data and revised consent language.
- CP101 is an oral microbiome therapeutic for recurrent C. difficile infection, in late-stage development.
- PRISM4 enrollment to resume after manufacturing activities, quality updates, and FDA agreement on protocol amendment and validation package.
- Timing update for PRISM4 and AUSPIRE Phase 1b trial of FIN-211 expected with Q1 2022 results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1733257/000095017022006581/0000950170-22-006581-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1733257/000095017022006581/fnch-20220428.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-006581

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