{"success":true,"data":{"pressRelease":{"id":"164817","rtpr_id":"nGNX54VVfl-20261008","ticker":"AGMB","exchange":"NASDAQ","all_tickers":["AGMB"],"title":"Agomab to Present STENOVA Open-Label Extension Data of Ontunisertib at UEG Week 2026 and Host Scientific Symposium on Fibro-Inflammation","author":"Globe Newswire","published_at":"2026-10-08T20:05:00.489Z","article_body":"-- Open-Label Extension (OLE) Data of STENOVA Phase 2a study with\nontunisertib in Fibrostenosing Crohn’s disease (FSCD) selected for oral\npresentation at UEG Week 2026 --\n\n-- Results support initiation of global NOV-ERA Phase 2b study in FSCD --\n\n-- Agomab-sponsored symposium to discuss the importance of targeting\nfibro-inflammation in inflammatory bowel disease (IBD) --\n\nAntwerp, Belgium, October 8, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=4dNM_66FryErNoEbi_ik7Hfaq5d6KeSLcFaD7pBkLz76Q8Ps3llMrcvnpHGEH6O-Emm_d1j0eb4cXzlzDCN3YayETdGT7xx4OrShi0tCYIM=)\n(‘Agomab’) a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced that OLE data of the Phase 2a STENOVA\nstudy will be presented in an oral session at United European Gastroenterology\n(UEG) Week 2026, taking place October 17-20 in Barcelona, Spain. The OLE study\n(Part B of STENOVA) evaluated long-term treatment with ontunisertib 200 mg BID\nfor up to 60 weeks in symptomatic FSCD patients. The study assessed the\nlong-term safety and PK profile of ontunisertib and explored the event rate\nand disease progression in FSCD patients.\n\nThe Company also announced that it will host an industry-sponsored scientific\nsymposium focused on the role of fibro-inflammation in IBD. The symposium will\nexplore the evolving understanding of fibro-inflammation in IBD, including the\ninterplay between inflammation and fibrosis in structural disease progression,\nand emerging therapeutic strategies designed to address both inflammatory and\nfibrotic components of disease.\n\nFlorian Rieder, MD, Vice-Chair, Department of Gastroenterology, Hepatology and\nNutrition, Cleveland Clinic, commented: “I am pleased to present the OLE\ndata at UEG Week, which provide important insights into extended treatment\nwith ontunisertib. The findings highlight the potential of ontunisertib to\nprovide a meaningful clinical benefit for people living with FSCD. I also look\nforward to joining leading experts in the symposium on fibro-inflammation and\ndiscussing how a deeper understanding of the crosstalk between inflammation\nand fibrosis may help advance therapeutic approaches for patients facing\ntherapeutic resistance and progressive bowel damage.”\n\nPhilippe Wiesel, Chief Medical Officer of Agomab, added: “The oral\npresentation of the STENOVA OLE data at UEG Week provides an important\nopportunity to share the growing body of evidence supporting ontunisertib in\nFSCD with the global gastroenterology community. The OLE results reinforce our\nconfidence in the potential of ontunisertib as we advance the global Phase 2b\nNOV-ERA study in the coming months. We are also delighted to convene leading\nexperts for a discussion on fibro-inflammation, a rapidly evolving area of\nscience that is reshaping our understanding of disease progression in IBD.”\n\nDetails of the Company’s events are as follows:\n\nAgomab Scientific Symposium(1)\n\nTitle: A New Treatment Paradigm: Addressing Fibro-Inflammation in IBD \nDate & Time: Monday October 19, 17:30-18:30 CET\nPresenters: Florian Rieder, M.D.; Geert D'Haens, M.D.; and Bruce E. Sands,\nM.D., M.S.\nLocation: Room D3\n\nUEG Week Oral Presentation\n\nTitle: STENOVA Trial Update: Open-Label Extension of Ontunisertib in\nFibrostenosing Crohn's Disease with Objective Imaging Efficacy Assessments\nDate & Time: Tuesday October 20, 12:10-12:20 CET\nPresenter: Florian Rieder, M.D.\nSession: Looking into the future; Novel therapeutics in IBD (Part 2)\nLocation: Room B3\n\nOntunisertib is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout STENOVA\nSTENOVA, a first-in-indication study, was a two-part Phase 2a trial in\nCrohn’s patients with symptomatic ileal strictures. Part A was a randomized,\ndouble-blind, placebo-controlled study in a total of 103 participants.\nParticipants were randomized to receive either 100mg QD or 200mg BID of\nontunisertib or placebo for 12 weeks on top of standard of care, including\nanti-inflammatory biologics. The study was conducted in investigational sites\nin the USA, Canada and six European countries. The primary endpoint was the\nevaluation of the safety and tolerability of ontunisertib in FSCD patients.\nSecondary endpoints included pharmacokinetics (PK) and target engagement.\nExploratory endpoints included the Simple Endoscopic Score of Crohn’s\ndisease (SES-CD) and novel FSCD specific endpoints such as the Stricturing\nPatient Reported Outcome (S-PRO) score and MRE. Eligible study participants\nwho completed the double-blind 12-week treatment period could participate in\nthe OLE part of the STENOVA study (Part B) and receive ontunisertib 200mg BID\nfor up to an additional 48 weeks. 49 patients rolled over (94% of eligible\npatients of STENOVA Part A) and 37 patients completed the 48-week OLE Part B\nof STENOVA. The OLE study assessed the long-term safety and PK profile of\nontunisertib and explored the event rate and disease progression in FSCD\npatients.\n\nAbout NOV-ERA\nThe planned NOV-ERA study is a randomized, double-blind, placebo-controlled,\ndose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of\nontunisertib in participants diagnosed with symptomatic FSCD. The trial is\nexpected to enroll up to 320 adult patients globally. To be eligible for the\ntrial, participants must have at least one naive or anastomotic endoscopically\nnon-passable ileal stricture, confirmed by a centrally read Simple Endoscopic\nScore for Crohn’s Disease (SES-CD). Upon study initiation, participants will\nbe randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of\nthree dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo,\nadministered twice daily (BID). The trial will consist of a 6-week screening\nperiod, a 52-week treatment period, and a 2-week follow-up period. The primary\nendpoint is the proportion of patients achieving endoscopic passability of the\nileal index stricture at Week 24. The Company plans to initiate the NOV-ERA\nstudy in the coming months.\n\nAbout Ontunisertib\nOntunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of\nALK5 (or TGF-β RI) currently in clinical development for the treatment of\nFibrostenosing Crohn’s Disease (FSCD). TGF-β is a major driver of fibrosis.\nOntunisertib is specifically designed to inhibit ALK5/TGF-β in the GI-tract.\nRapid first-pass metabolism in the liver prevents clinically relevant systemic\nexposure, potentially delivering an improved safety profile over systemically\navailable inhibitors in this class. Ontunisertib has received U.S. FDA Fast\nTrack Designation.\n\nAbout Agomab\nAgomab is a clinical-stage biopharmaceutical company focused on developing\nnovel disease-modifying therapies for fibro-inflammatory diseases with high\nunmet medical need. Agomab’s product candidates are designed to target\nestablished, potent pathways and utilize organ-restricted approaches, with\nthe aim of increasing efficacy while minimizing safety liabilities. Fostering\na culture of excellence, Agomab’s mission is to pioneer therapeutics that\naim to resolve fibro-inflammation and restore organ function to enable people\nwith these disorders to live fuller and healthier lives.\n\nCautionary Note regarding Forward-Looking Statements\nThis press release includes certain disclosures that contain \"forward-looking\nstatements\" within the meaning of Section 27A of the Securities Act of 1933,\nas amended, and Section 21E of the Securities Exchange Act of 1934, as\namended. Forward-looking statements are often identified by terms such as\n\"continue,\" \"anticipate,\" \"believe,\" \"could,\" \"estimate,\" \"expect,\" \"goal,\"\n\"intend,\" \"look forward to,\" \"may,\" \"plan,\" \"potential,\" \"predict,\" \"project,\"\n\"should,\" \"will,\" \"would\" and similar expressions. “Forward-looking\nstatements” include, without limitation, statements regarding the potential\nof ontunisertib for Fibrostenosing Crohn’s disease, including its potential\nto deliver an improved safety profile over systemically available inhibitors\nin its class, the expected initiation and conduct of the NOV-ERA Phase 2b\nstudy, and our interactions with regulatory authorities. Forward-looking\nstatements are based on Agomab’s current expectations and are subject to\ninherent uncertainties, risks and assumptions that are difficult to predict.\nFactors that could cause actual results to differ include, but are not limited\nto, risks and uncertainties related to the results of our clinical trials,\nincluding the risk that Phase 2a results may not be predictive of Phase 2b or\nlater-stage outcomes; expectations regarding the inherent uncertainties\nassociated with the development of novel drug therapies; preclinical and\nclinical trial and product development activities and regulatory approval\nrequirements for product candidates; the risk that the NOV-ERA Phase 2b study\nmay not be initiated on the anticipated timeline, or at all; the impact of\ngovernmental laws and regulations on our business; competition and potential\nfor technological or therapeutic change in the field; the substantial\nadditional investment required before any product candidate may be\ncommercialized; and disruptions caused by our reliance on third party\nsuppliers and service providers. These and other risks and uncertainties are\ndescribed more fully in our filings and reports with the SEC, including in our\nmost recent annual report on Form 20‐F filed with the SEC and our subsequent\nfilings and reports filed with the SEC. Forward-looking statements contained\nin this announcement are made as of this date, and Agomab undertakes no duty\nto update such information except as required under applicable law. Readers\nshould not rely upon the information in this announcement as current or\naccurate after its publication date.\n\nContacts\nInvestors\nSofie Van Gijsel\nVP of Investor Relations\nE-Mail: sofie.vangijsel@agomab.com\nPhone: +1 781 296 1143\n        \nMedia\nGretchen Schweitzer\nTrophic Communications\nE-Mail: agomab@trophic.eu \nPhone: +49 172 861 8540\n\n(1) This program is independent and is not affiliated with UEG Week 2026. The\nprogram is intended solely for scientific and educational exchange. The\ncontent is non-promotional and is not intended to promote any product or\nindication. The speakers express their own opinion and experience, which do\nnot necessarily reflect the position of Agomab.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/7f797bcb-5d5d-4fb6-a862-b5c861b83e54)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX54VVfl-20261008","title":"Agomab to Present STENOVA Open-Label Extension Data of Ontunisertib at UEG Week 2026 and Host Scientific Symposium on Fibro-Inflammation","author":"Globe Newswire","ticker":"AGMB","created":"2026-10-08T20:05:00.489Z","tickers":["AGMB"],"exchange":"NASDAQ","article_body":"-- Open-Label Extension (OLE) Data of STENOVA Phase 2a study with\nontunisertib in Fibrostenosing Crohn’s disease (FSCD) selected for oral\npresentation at UEG Week 2026 --\n\n-- Results support initiation of global NOV-ERA Phase 2b study in FSCD --\n\n-- Agomab-sponsored symposium to discuss the importance of targeting\nfibro-inflammation in inflammatory bowel disease (IBD) --\n\nAntwerp, Belgium, October 8, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=4dNM_66FryErNoEbi_ik7Hfaq5d6KeSLcFaD7pBkLz76Q8Ps3llMrcvnpHGEH6O-Emm_d1j0eb4cXzlzDCN3YayETdGT7xx4OrShi0tCYIM=)\n(‘Agomab’) a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced that OLE data of the Phase 2a STENOVA\nstudy will be presented in an oral session at United European Gastroenterology\n(UEG) Week 2026, taking place October 17-20 in Barcelona, Spain. The OLE study\n(Part B of STENOVA) evaluated long-term treatment with ontunisertib 200 mg BID\nfor up to 60 weeks in symptomatic FSCD patients. The study assessed the\nlong-term safety and PK profile of ontunisertib and explored the event rate\nand disease progression in FSCD patients.\n\nThe Company also announced that it will host an industry-sponsored scientific\nsymposium focused on the role of fibro-inflammation in IBD. The symposium will\nexplore the evolving understanding of fibro-inflammation in IBD, including the\ninterplay between inflammation and fibrosis in structural disease progression,\nand emerging therapeutic strategies designed to address both inflammatory and\nfibrotic components of disease.\n\nFlorian Rieder, MD, Vice-Chair, Department of Gastroenterology, Hepatology and\nNutrition, Cleveland Clinic, commented: “I am pleased to present the OLE\ndata at UEG Week, which provide important insights into extended treatment\nwith ontunisertib. The findings highlight the potential of ontunisertib to\nprovide a meaningful clinical benefit for people living with FSCD. I also look\nforward to joining leading experts in the symposium on fibro-inflammation and\ndiscussing how a deeper understanding of the crosstalk between inflammation\nand fibrosis may help advance therapeutic approaches for patients facing\ntherapeutic resistance and progressive bowel damage.”\n\nPhilippe Wiesel, Chief Medical Officer of Agomab, added: “The oral\npresentation of the STENOVA OLE data at UEG Week provides an important\nopportunity to share the growing body of evidence supporting ontunisertib in\nFSCD with the global gastroenterology community. The OLE results reinforce our\nconfidence in the potential of ontunisertib as we advance the global Phase 2b\nNOV-ERA study in the coming months. We are also delighted to convene leading\nexperts for a discussion on fibro-inflammation, a rapidly evolving area of\nscience that is reshaping our understanding of disease progression in IBD.”\n\nDetails of the Company’s events are as follows:\n\nAgomab Scientific Symposium(1)\n\nTitle: A New Treatment Paradigm: Addressing Fibro-Inflammation in IBD \nDate & Time: Monday October 19, 17:30-18:30 CET\nPresenters: Florian Rieder, M.D.; Geert D'Haens, M.D.; and Bruce E. Sands,\nM.D., M.S.\nLocation: Room D3\n\nUEG Week Oral Presentation\n\nTitle: STENOVA Trial Update: Open-Label Extension of Ontunisertib in\nFibrostenosing Crohn's Disease with Objective Imaging Efficacy Assessments\nDate & Time: Tuesday October 20, 12:10-12:20 CET\nPresenter: Florian Rieder, M.D.\nSession: Looking into the future; Novel therapeutics in IBD (Part 2)\nLocation: Room B3\n\nOntunisertib is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout STENOVA\nSTENOVA, a first-in-indication study, was a two-part Phase 2a trial in\nCrohn’s patients with symptomatic ileal strictures. Part A was a randomized,\ndouble-blind, placebo-controlled study in a total of 103 participants.\nParticipants were randomized to receive either 100mg QD or 200mg BID of\nontunisertib or placebo for 12 weeks on top of standard of care, including\nanti-inflammatory biologics. The study was conducted in investigational sites\nin the USA, Canada and six European countries. The primary endpoint was the\nevaluation of the safety and tolerability of ontunisertib in FSCD patients.\nSecondary endpoints included pharmacokinetics (PK) and target engagement.\nExploratory endpoints included the Simple Endoscopic Score of Crohn’s\ndisease (SES-CD) and novel FSCD specific endpoints such as the Stricturing\nPatient Reported Outcome (S-PRO) score and MRE. Eligible study participants\nwho completed the double-blind 12-week treatment period could participate in\nthe OLE part of the STENOVA study (Part B) and receive ontunisertib 200mg BID\nfor up to an additional 48 weeks. 49 patients rolled over (94% of eligible\npatients of STENOVA Part A) and 37 patients completed the 48-week OLE Part B\nof STENOVA. The OLE study assessed the long-term safety and PK profile of\nontunisertib and explored the event rate and disease progression in FSCD\npatients.\n\nAbout NOV-ERA\nThe planned NOV-ERA study is a randomized, double-blind, placebo-controlled,\ndose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of\nontunisertib in participants diagnosed with symptomatic FSCD. The trial is\nexpected to enroll up to 320 adult patients globally. To be eligible for the\ntrial, participants must have at least one naive or anastomotic endoscopically\nnon-passable ileal stricture, confirmed by a centrally read Simple Endoscopic\nScore for Crohn’s Disease (SES-CD). Upon study initiation, participants will\nbe randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of\nthree dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo,\nadministered twice daily (BID). The trial will consist of a 6-week screening\nperiod, a 52-week treatment period, and a 2-week follow-up period. The primary\nendpoint is the proportion of patients achieving endoscopic passability of the\nileal index stricture at Week 24. The Company plans to initiate the NOV-ERA\nstudy in the coming months.\n\nAbout Ontunisertib\nOntunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of\nALK5 (or TGF-β RI) currently in clinical development for the treatment of\nFibrostenosing Crohn’s Disease (FSCD). TGF-β is a major driver of fibrosis.\nOntunisertib is specifically designed to inhibit ALK5/TGF-β in the GI-tract.\nRapid first-pass metabolism in the liver prevents clinically relevant systemic\nexposure, potentially delivering an improved safety profile over systemically\navailable inhibitors in this class. Ontunisertib has received U.S. FDA Fast\nTrack Designation.\n\nAbout Agomab\nAgomab is a clinical-stage biopharmaceutical company focused on developing\nnovel disease-modifying therapies for fibro-inflammatory diseases with high\nunmet medical need. Agomab’s product candidates are designed to target\nestablished, potent pathways and utilize organ-restricted approaches, with\nthe aim of increasing efficacy while minimizing safety liabilities. Fostering\na culture of excellence, Agomab’s mission is to pioneer therapeutics that\naim to resolve fibro-inflammation and restore organ function to enable people\nwith these disorders to live fuller and healthier lives.\n\nCautionary Note regarding Forward-Looking Statements\nThis press release includes certain disclosures that contain \"forward-looking\nstatements\" within the meaning of Section 27A of the Securities Act of 1933,\nas amended, and Section 21E of the Securities Exchange Act of 1934, as\namended. Forward-looking statements are often identified by terms such as\n\"continue,\" \"anticipate,\" \"believe,\" \"could,\" \"estimate,\" \"expect,\" \"goal,\"\n\"intend,\" \"look forward to,\" \"may,\" \"plan,\" \"potential,\" \"predict,\" \"project,\"\n\"should,\" \"will,\" \"would\" and similar expressions. “Forward-looking\nstatements” include, without limitation, statements regarding the potential\nof ontunisertib for Fibrostenosing Crohn’s disease, including its potential\nto deliver an improved safety profile over systemically available inhibitors\nin its class, the expected initiation and conduct of the NOV-ERA Phase 2b\nstudy, and our interactions with regulatory authorities. Forward-looking\nstatements are based on Agomab’s current expectations and are subject to\ninherent uncertainties, risks and assumptions that are difficult to predict.\nFactors that could cause actual results to differ include, but are not limited\nto, risks and uncertainties related to the results of our clinical trials,\nincluding the risk that Phase 2a results may not be predictive of Phase 2b or\nlater-stage outcomes; expectations regarding the inherent uncertainties\nassociated with the development of novel drug therapies; preclinical and\nclinical trial and product development activities and regulatory approval\nrequirements for product candidates; the risk that the NOV-ERA Phase 2b study\nmay not be initiated on the anticipated timeline, or at all; the impact of\ngovernmental laws and regulations on our business; competition and potential\nfor technological or therapeutic change in the field; the substantial\nadditional investment required before any product candidate may be\ncommercialized; and disruptions caused by our reliance on third party\nsuppliers and service providers. These and other risks and uncertainties are\ndescribed more fully in our filings and reports with the SEC, including in our\nmost recent annual report on Form 20‐F filed with the SEC and our subsequent\nfilings and reports filed with the SEC. Forward-looking statements contained\nin this announcement are made as of this date, and Agomab undertakes no duty\nto update such information except as required under applicable law. Readers\nshould not rely upon the information in this announcement as current or\naccurate after its publication date.\n\nContacts\nInvestors\nSofie Van Gijsel\nVP of Investor Relations\nE-Mail: sofie.vangijsel@agomab.com\nPhone: +1 781 296 1143\n        \nMedia\nGretchen Schweitzer\nTrophic Communications\nE-Mail: agomab@trophic.eu \nPhone: +49 172 861 8540\n\n(1) This program is independent and is not affiliated with UEG Week 2026. The\nprogram is intended solely for scientific and educational exchange. The\ncontent is non-promotional and is not intended to promote any product or\nindication. The speakers express their own opinion and experience, which do\nnot necessarily reflect the position of Agomab.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/7f797bcb-5d5d-4fb6-a862-b5c861b83e54)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-08T20:05:00.54044208Z","server_sent_at_ms":1791489900540},"received_at":"2026-10-08T20:05:00.594Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}