IPO and NASDAQ Debut
Fractyl Health completed its IPO, debuting on the NASDAQ under the ticker symbol GUTS, strengthening its financial position.
Regulatory Achievements
Secured FDA IDE approval for a pivotal study of Revita and earned FDA Breakthrough Device designation for weight maintenance after GLP-1 drug discontinuation.
Clinical Study Progress
Initiated the REMAIN-1 pivotal study with a strong patient enrollment, showing demand for an off-ramp to GLP-1 drugs. Over 189 patients enrolled across 13 clinical sites in six months.
Positive Early Patient Results
Initial results from REVEAL-1 showed a patient maintained weight loss during a challenging holiday period, suggesting Revita's potential effectiveness.
Rejuva Platform Advancements
Advanced Rejuva gene therapy platform, with preclinical data showing promise in preventing weight and glycemic rebound.
Financial Stability
Fractyl had $67.5 million in cash and cash equivalents, expected to fund operations through key clinical milestones into 2026.