BOSTON–Fractyl Health plans to lay off approximately 45% of its workforce as the Burlington-based biotechnology company shifts resources toward its lead obesity treatment, following positive results from a pivotal clinical trial.
The company announced the workforce reduction Oct. 22, saying the cuts are intended to streamline operations and focus spending on Revita, an investigational treatment designed to help people maintain weight loss after discontinuing GLP-1 medications such as Wegovy and Zepbound. The layoffs are expected to be substantially completed by November.
Fractyl also plans to discontinue internal development of its Rejuva gene therapy program and seek strategic alternatives to maximize its value. In addition, Jay Caplan, the company’s co-founder, president and chief product officer, will retire from his executive roles effective Oct. 30 and is expected to remain involved as a senior adviser.
The restructuring comes as Fractyl seeks to advance Revita toward potential U.S. Food and Drug Administration authorization. The company said positive six-month results from its REMAIN-1 pivotal trial support its plans to submit an FDA De Novo application in late 2026.
“We believe this focused strategy will position Fractyl to operate more efficiently and advance Revita toward its clinical and commercial potential,” Chief Executive Harith Rajagopalan said in a statement. He also acknowledged the impact of the changes on employees and thanked departing colleagues for their contributions.
Fractyl expects the workforce reduction and other cost-cutting measures to reduce its quarterly operating cash burn by approximately 50%, to about $8 million, by the end of the second quarter of 2027. The company said its existing cash and cash equivalents are expected to fund operations into the second quarter of next year.
The company’s latest restructuring follows encouraging results for Revita, which met its prespecified six-month co-primary endpoint in the REMAIN-1 pivotal cohort, showing a statistically significant difference in weight regain compared with a sham procedure. The company reported a p-value of 0.0023.
Revita is designed to alter the lining of the duodenum, the first portion of the small intestine, with the aim of addressing metabolic changes associated with obesity. Fractyl is developing the procedure as a potential option for patients who regain weight after stopping GLP-1 drugs, a growing challenge as these medications become more widely used.
The company expects to report 12-month pivotal trial data in the first quarter of 2027. Those results could help inform its regulatory plans and the treatment’s potential path toward commercialization.
Despite the positive trial results, Revita remains investigational and has not received FDA marketing authorization. Its future development and commercial prospects will depend on additional clinical evidence and regulatory review.
Fractyl’s decision to discontinue internal development of Rejuva marks a further narrowing of its research priorities as it directs capital and personnel toward Revita’s upcoming clinical and regulatory milestones.
The company, which trades on the Nasdaq under the ticker GUTS, said the restructuring is intended to align its organization with what it sees as its most immediate opportunity in obesity treatment.
