GUTSGlobeNewsWireFractyl Health Sharpens Focus on Revita Following Positive Pivotal Results, Advancing Toward Planned FDA De Novo Submission in Post-GLP-1 Weight Maintenance
Following positive topline six-month REMAIN-1 pivotal results, Revita advancing toward planned FDA De Novo submission in late Q4 2026 and anticipated 12-month pivotal data readout in Q1 2027 Workforce reduction aligns organization behind Revita's near-term clinical and commercial opportunity Company discontinuing development of Rejuva candidates and seeking strategic alternatives to maximize the value of its Rejuva gene therapy program Cash runway extended into Q2 2027; quarterly operating cash burn expected to be reduced by ~50% to approximately $8 million by end of Q2 2027 BURLINGTON, Mass., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it is sharpening its focus and concentrating its financial and operational resources on advancing Revita®, its lead product candidate, toward potential U.S. Food and Drug Administration (FDA) marketing authorization and commercialization in post-GLP-1 weight maintenance.