regulatory
confidence high
sentiment positive
materiality 0.70
Finch Therapeutics announces FDA removal of clinical hold on CP101 IND; prepares to resume PRISM4 Phase 3 trial
Finch Therapeutics Group, Inc.
- 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.