Fractyl Health, Inc. (Nasdaq: GUTS) announced on October 21, 2026, that it is reprioritizing its operations to sharpen its focus on its Revita program. The company disclosed a plan to reduce its workforce by approximately 45% and discontinue internal development of its Rejuva gene therapy program.
The restructuring is intended to streamline the organization and concentrate resources on advancing Revita toward potential FDA marketing authorization. The company cited positive topline six-month results from the REMAIN-1 pivotal cohort as a key factor in this strategic shift. The REMAIN-1 trial met its prespecified six-month co-primary endpoint with high statistical significance regarding weight regain compared to sham (p=0.0023).
In connection with the workforce reduction, the company estimates it will incur charges of approximately $2 million for severance and other termination-related costs, with the majority of these costs expected in the fourth quarter of 2026. The reduction in force is expected to be completed during the fourth quarter of 2026.
Fractyl also announced the retirement of Jay Caplan, the company’s President and Chief Product Officer, effective October 30, 2026. Mr. Caplan will be entitled to severance benefits as set forth in his employment agreement and is expected to support the company as a senior advisor following his departure.
On October 21, 2026, the Board of Directors appointed Dr. Harith Rajagopalan, the company’s Co-Founder, Chief Executive Officer, and Director, to serve as President, effective as of the Separation Date. Dr. Rajagopalan will continue to serve as the principal executive officer.
Regarding the Rejuva program, the company is discontinuing internal development and is seeking strategic alternatives to maximize the value of the program. The company anticipates its existing cash and cash equivalents to fund operations into the second quarter of 2027. It also expects its quarterly operating cash burn to be reduced by approximately 50% to approximately $8 million by the end of the second quarter of 2027.
Fractyl plans to submit a De Novo marketing application for Revita to the FDA in late 2026 and anticipates topline 12-month pivotal data from the REMAIN-1 Pivotal Cohort in the first quarter of 2027.
