Fractyl Health Announces Heightened Focus On Advancing Revita Toward Potential FDA Marketing Authorization And Commercialization In Post-GLP-1 Weight Maintenance
Benzinga Newsdesk 1 week ago
FDANews
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 2027Workforce reduction aligns
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