Fractyl Health Announces Heightened Focus On Advancing Revita Toward Potential FDA Marketing Authorization And Commercialization 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