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Fractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Post-GLP-1 Weight Maintenance Therapeutic Category

GUTS
  • Fractyl Health expects to release 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026.
  • Topline 6-month data from the REMAIN-1 Pivotal Cohort & a potential PMA submission for Revita are anticipated in H2 2026.
  • The Company holds approximately $85.6 million in cash & cash equivalents, supporting operations through early 2027.
  • Fractyl received $23.0 million in gross proceeds from Tranche A warrant exercises completed in August 2025.
  • Early 2026 marks the completion of randomizations for the REMAIN-1 Pivotal Cohort.
  • Q2 2026 will feature 1-year data from the REVEAL-1 Cohort.
  • Q3 2026 is scheduled for 1-year data release from the REMAIN-1 Midpoint Cohort.
  • Fractyl plans to advance the Rejuva gene therapy platform toward first-in-human (FIH) evaluation of RJVA-001 in H2 2026, subject to regulatory authorization.
  • Regulatory feedback on the Clinical Trial Application (CTA) for RJVA-001 is expected in Q2 2026.
  • The Revita program targets post-GLP-1 weight maintenance as a key unmet need in obesity care.
  • Fractyl possesses a robust intellectual property portfolio including 35 granted U.S. patents & approximately 45 pending U.S. applications.
  • RJVA-002, a dual GIP/GLP-1 gene therapy candidate, demonstrated approximately 30% weight loss in preclinical studies.