--- title: "Fractyl shares fall 48% even as Revita meets six-month REMAIN-1 endpoint" url: "https://aibio.space/news/fractyl-shares-fall-48-percent-even-revita-meets-six-month-remain-1/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-10-16" section: "Distress" tickers: "NASDAQ:GUTS" source: "https://www.rttnews.com/story.aspx?Id=3699844" summary: "Patients kept about 80% of their tirzepatide weight loss after one Revita procedure versus 67% after sham. Fractyl plans a De Novo filing in late fourth qu" --- By the aibio.space news desk. Sources - [RTTNews](https://www.rttnews.com/story.aspx?Id=3699844) - [Fractyl press release (SEC 8-K exhibit)](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-ex99_1.htm) - [Fractyl 8-K](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-20261016.htm) - [HCPLive](https://www.hcplive.com/view/revita-reduces-weight-regain-after-glp-1-discontinuation-in-remain-1) - [Benzinga via KuCoin](https://www.kucoin.com/news/flash/fractyl-health-shares-drop-47-6-amid-clinical-results-and-legal-action) - [TheFly via TipRanks](https://www.tipranks.com/news/the-fly/fractyl-health-announces-remain-1-study-met-3-month-efficacy-endpoint-thefly) [GUTS](https://aibio.space/companies/fractyl-health/) 2026-10-16 # Fractyl shares fall 48% even as Revita meets six-month REMAIN-1 endpoint Tickers [GUTS](https://aibio.space/companies/fractyl-health/) Patients kept about 80% of their tirzepatide weight loss after one Revita procedure versus 67% after sham. Fractyl plans a De Novo filing in late fourth quarter 2026. ## Key facts - **Company**: Fractyl Health, Inc. (NASDAQ: GUTS) - **News type**: Distress - **Primary source**: [RTTNews](https://www.rttnews.com/story.aspx?Id=3699844) *A supreme court building with lit columns. CC0, via rawpixel. The picture shows the field, not the companies named.* Fractyl Health said on October 16 that the registrational cohort of its REMAIN-1 study [met its six-month co-primary endpoint](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-ex99_1.htm). Patients who had a single Revita procedure after stopping tirzepatide kept about 80% of their drug-induced weight loss, against 67% for patients who had a sham procedure. Investors did not reward the result. According to [RTTNews](https://www.rttnews.com/story.aspx?Id=3699844), Fractyl shares fell about 48% to around $2.14 on October 16, from a prior close of $4.16, on volume of 10.59 million shares against an average of about 147,000. ## The details REMAIN-1 is randomized, double-blind and sham-controlled, at more than 30 US sites. It enrolled 308 adults with a BMI of 30 to 45, without type 2 diabetes and with no prior GLP-1 use. Everyone took tirzepatide until they lost at least 15% of body weight, then stopped and was randomized 2:1 to Revita or sham, [HCPLive reported](https://www.hcplive.com/view/revita-reduces-weight-regain-after-glp-1-discontinuation-in-remain-1). At six months, least-squares mean weight regain was 5.1% of body weight with Revita and 8.2% with sham (p=0.0023), [according to the company's 8-K](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-20261016.htm). In a post hoc look, 32% of Revita patients were weight-stable or still losing versus 18% on sham, and patients with 20 cm or more of treated duodenum regained 3.8%. The second co-primary endpoint is read at 12 months: the share of Revita patients who keep at least 5% total body weight loss from their pre-tirzepatide weight, measured against an [FDA-set performance goal of more than 50%](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-ex99_1.htm). Through a September 24 data cutoff, there were no device- or procedure-related serious adverse events, and 94% of related adverse events occurred within seven days of the procedure. ## Context The stock was already down sharply this year. In January, Fractyl reported 4.5% six-month regain with Revita versus 7.5% for control, and a class action complaint says shares fell more than 68%, according to a [Benzinga report reposted by KuCoin](https://www.kucoin.com/news/flash/fractyl-health-shares-drop-47-6-amid-clinical-results-and-legal-action). The same report said Fractyl faces a securities class action covering buyers from January 13, 2025, to January 29, 2026, and that Morgan Stanley cut its estimated probability of success for Revita from 50% to 35%. The regulatory plan has also changed. In September 2025, Fractyl talked about a [potential PMA filing in the second half of 2026](https://www.tipranks.com/news/the-fly/fractyl-health-announces-remain-1-study-met-3-month-efficacy-endpoint-thefly). It now plans a De Novo application. "We intend to initiate our De Novo marketing application to the FDA in late Q4 2026," chief executive Harith Rajagopalan said in the [release](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-ex99_1.htm). Revita holds FDA Breakthrough Device designation and is CE marked in the EU and UK, [per HCPLive](https://www.hcplive.com/view/revita-reduces-weight-regain-after-glp-1-discontinuation-in-remain-1). ## What it means for investors The trial won on its first test, but the gap was [3.1 percentage points of body weight](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-20261016.htm) at six months. RTTNews gave no reason for the selloff. Most of the eye-catching numbers, such as the dose-response by ablation length, are post hoc. The larger test comes next. The 12-month responder endpoint is a fixed bar of more than 50%, and the company has not yet reported how many patients are on track to clear it. Other risks are the pending class action, FDA review of a De Novo request, and payment: a [Category III CPT code takes effect January 1, 2027](https://www.hcplive.com/view/revita-reduces-weight-regain-after-glp-1-discontinuation-in-remain-1), and the company is aiming for a US launch in early 2028. ## What to watch Fractyl plans to file its De Novo application in late fourth quarter 2026. Topline one-year data, including the second co-primary endpoint, are [expected in the first quarter of 2027](https://www.sec.gov/Archives/edgar/data/0001572616/000119312526423377/guts-ex99_1.htm). [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story GUTS Fractyl Health, Inc. NASDAQ ยท United States Open the desk ## More in Distress Distress ### [Mineralys takes ownership of lorundrostat patents but keeps Tanabe milestone debts](https://aibio.space/news/mineralys-takes-ownership-lorundrostat-patents-but-keeps-tanabe/) Oct 29, 2026 Distress ### [Bristol Myers Squibb drops Prothena's PRX019, ending up to $617.5 million in milestones](https://aibio.space/news/bristol-myers-squibb-drops-prothenas-prx019-ending-up-617-5-million/) Oct 29, 2026 Distress ### [LENZ Therapeutics reorganizes to cut 2027 operating expenses by more than 50%](https://aibio.space/news/lenz-therapeutics-reorganizes-cut-2027-operating-expenses-more-50/) Oct 28, 2026 --- Source page: https://aibio.space/news/fractyl-shares-fall-48-percent-even-revita-meets-six-month-remain-1/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Fractyl shares fall 48% even as Revita meets six-month REMAIN-1 endpoint", 2026-10-16, https://aibio.space/news/fractyl-shares-fall-48-percent-even-revita-meets-six-month-remain-1/