regulatory
confidence high
sentiment negative
materiality 0.85
Cue Health Inc.: restructuring charge — Cue Health lays off 13% of workforce; FDA rejects priority review for Flu+COVID test
Cue Health Inc.
- Workforce reduction of 94 employees (~13% global workforce) as part of new cost reduction plan.
- Estimated restructuring charges of $2.1M-$2.8M cash plus $0.1M non-cash stock-based.
- FDA on Dec 28, 2023 declined to issue EUA for Flu A/B + COVID-19 molecular test; review not a priority.
- FDA cites significant issues, COVID-19 testing landscape, and resource constraints; future EUA submission not precluded.