regulatory
confidence high
sentiment negative
materiality 0.70
Vivani Medical provides update on FDA clinical hold for NPM-119 diabetes implant
Vivani Medical, Inc.
- FDA placed full clinical hold on NPM-119 Phase 2a LIBERATE-1 study on Aug 18, 2023, due to CMC deficiencies.
- Second complete response submitted Sept 15, 2023; FDA has 30 days to respond.
- If hold lifted, trial start in 2023, interim data 1H2024, full top-line 2H2024.
- If response deemed inadequate, Vivani will provide updated guidance.