other material
confidence high
sentiment neutral
materiality 0.75
Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation
FRACTYL HEALTH, INC.
- Net loss of $17.2M vs $30.2M in Q2 2023; cash and equivalents $102.4M as of June 30, 2024.
- FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 discontinuation.
- REMAIN-1 pivotal study for Revita initiated; open label data expected Q4 2024; midpoint analysis Q2 2025.
- REVITALIZE-1 on track to report topline data mid-2025 in expanded T2D population (protocol amendment approved).
- Chairman Allan Will stepped down; Ajay Royan appointed new Chair effective August 2024.