Fractyl Health Inc. (NASDAQ:GUTS) stock plunged on Thursday after the company hinted at a change in its U.S. regulatory strategy for Revita.
Fractyl Health sotck hit its 52-week low with a session volume of 78.07 million compared to the average volume of 3.31 million, according to Benzinga Pro data.
Revita is the company’s lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease.
Revita has received FDA Breakthrough Device designation for weight maintenance in patients who discontinue GLP-1 therapies.
Based on ongoing interactions with the U.S. Food and Drug Administration (FDA) and the safety and tolerability data observed to date, Fractyl requested FDA feedback on potentially reclassifying Revita under the De Novo pathway, rather than a Premarket Approval (PMA).
The De Novo pathway is intended for novel medical devices with low-to-moderate risk profiles and may enable a more efficient, risk-based regulatory review process.
The company expects FDA feedback regarding the potential for use of the De Novo pathway in the second quarter of 2026.
The update follows six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort evaluating Revita for weight maintenance following GLP-1 drug discontinuation. 12-month randomized data is expected in the third quarter of 2026.
Weight maintenance benefit
Across the prespecified efficacy population, Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months (p=0.07, one-sided), consistent with meaningful and sustained attenuation of the expected post-GLP-1 rebound trajectory.
An exploratory analysis of patients who achieved above median weight loss during GLP-1 run-in (n=20) showed that Revita-treated participants experienced 4.2% weight regain versus 13.3% with sham at 6 months, corresponding to an approximately 70% relative reduction in post-GLP-1 weight regain.
Revita-treated patients demonstrated improvements in cardiometabolic lipid parameters versus sham at 6 months, including increased HDL cholesterol (15.5 vs 3.9 mg/dL) and reduced triglyceride-to-HDL ratio (-0.2 vs +0.4), suggesting improved metabolic regulation following GLP-1 discontinuation.
Patient-reported outcomes showed meaningful reductions in sweet-food craving versus sham (1.8 vs 3.4).
Safety Profile
Revita continued to demonstrate favorable safety and tolerability results through six months, with no treatment-emergent serious adverse events related to the device or procedure, and no study discontinuations due to adverse events.
No new related adverse events were observed between 3- and 6-month follow-up.
Price Action: GUTS stock is down 64.81% at $0.644 during the premarket session at the last check on Thursday.
Photo by Tada Images via Shutterstock
Recent Comments