Fractyl Health ( GUTS ) is developing endoscopic procedures to manage metabolic diseases (obesity and diabetes). The lead candidate is Revita, currently being evaluated in a registrational ph3 trial with topline results expected in 2H 2026, followed byhttps://biotechpharmainvestor.substack.comhttps://x.com/StmkrsBackground: Physician involved in clinical research. Investment style: Clinical-stage biotech stocks, long only, both long-term ideas and event-driven trading. My academic/medical background helps m ...

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

LOS ANGELES--(BUSINESS WIRE)--Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTS. ...

Morgan Stanley has set a new price target for NASDAQ:GUTS at $2, indicating a potential increase of about 245% from its current trading price.The stock has experienced a significant decrease of 68.04%, trading at $0.58, down from its previous levels.GUTS has shown volatility with a yearly high of $3.03 and a low of $0.56, alongside a trading volume of 87.51 million shares, reflecting active investor interest.GUTS, trading on the NASDAQ, is currently under the spotlight following Morgan Stanley's price targe ...

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 ...

Core Viewpoint - Fractyl Health is conducting a conference call to discuss the 6-month REMAIN-1 Midpoint Cohort results, with a focus on the company's developments and future outlook [1][2]. Group 1: Company Overview - The conference is led by Lara Smith-Weber, the Chief Financial Officer, and features Dr. Harith Rajagopalan, the Co-Founder and CEO of Fractyl Health [1][2]. - A press release detailing the topics for discussion has been issued and is available on the company's website under the Investors tab [2]. Group 2: Forward-Looking Statements - The company will make forward-looking statements during the call, which involve risks and uncertainties that could lead to actual results differing from these statements [3]. - A comprehensive list of risk factors is provided in the company's SEC filings, including the quarterly report Form 10-Q filed on November 12, 2025 [3].

Fractyl Health (NasdaqGM:GUTS) Update / briefing January 29, 2026 08:00 AM ET Company ParticipantsHarith Rajagopalan - CEOJeffrey Cohen - Director of ResearchJoseph Pantginis - Managing Director of Equity ResearchLara Smith Weber - CFOMichael DiFiore - Managing DirectorMike Ulz - Executive Director of Biotechnology Equity ResearchConference Call ParticipantsWhitney Ijem - Managing Director of Senior Biotechnology AnalystNone - AnalystOperatorGreetings. Welcome to the Fractyl Health six-month REMAIN-1 midpoi ...

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6- ...

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6- ...

Several healthcare and biotech stocks posted solid gains in Tuesday's after-hours session, with most moves occurring without company-specific news.Acumen Pharmaceuticals, Inc. (ABOS) advanced 8.09% to close at $2.94 after hours, adding $0.22 to its share price.Fulgent Genetics, Inc. (FLGT) rose 5.98% to $28.90 as of 6:59 p.m. EST, gaining $1.63 in extended trading.Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23, up $0.11 after hours.Coeptis Therapeutics Holdings, Inc. (COEP) added 4.14% to finish at $13 ...