regulatory
confidence high
sentiment negative
materiality 0.85
Finch Therapeutics pauses Phase 3 PRISM4 trial; FDA clinical hold on CP101; dosing occurred while hold in effect
Finch Therapeutics Group, Inc.
- 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.