{"success":true,"data":{"pressRelease":{"id":"168126","rtpr_id":"nGNE2nyywB-20261013","ticker":"AGMB","exchange":"NASDAQ","all_tickers":["AGMB"],"title":"Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease","author":"Globe Newswire","published_at":"2026-10-13T20:05:00.059Z","article_body":"-- NOV-ERA is designed to assess the efficacy and safety of ontunisertib in\napproximately 320 patients with symptomatic Fibrostenosing Crohn's disease\n(FSCD) --\n\n-- Global, randomized, placebo-controlled, dose-ranging study to evaluate\nthree dose levels of ontunisertib, with endoscopic passability at Week 24 as\nprimary endpoint --\n\n-- Study initiation represents an important milestone in the development of\nontunisertib as a potential first targeted anti-fibrotic treatment for FSCD --\n\nAntwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=KXIid1wKoQtljNCQSys1L2yvpOBQhwbO3NvB4mxayrqzRY6Z-fS75HmiH9IMfnKUzfEg3ZH6N606ino9ZiZDMvNSqD8eBHwwVMKK-ES1Xs4=)\n(‘Agomab’), a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced that the first patient has been dosed in\nNOV-ERA, the Company's global Phase 2b study evaluating ontunisertib in\npatients with symptomatic FSCD.\n\nNOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase\n2b study designed to assess the safety and efficacy of ontunisertib. The study\nis expected to enroll approximately 320 adult patients globally. Participants\nwill be randomized to receive either ontunisertib at one of three dose levels\n(400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a\ntreatment duration of 52 weeks.\n\nThe initiation of NOV-ERA follows the positive Phase 2a STENOVA results that\nsupport continued clinical development of ontunisertib in FSCD. The recently\nannounced positive long-term safety and tolerability findings of the\nopen-label extension (OLE) part of the STENOVA Phase 2a study provide strong\nsupport for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.\n\nPhilippe Wiesel, Chief Medical Officer of Agomab, commented: “Dosing the\nfirst patient in NOV-ERA marks the beginning of an exciting next chapter for\nour Company and for the late-stage development of ontunisertib. FSCD is\nassociated with progressive bowel damage and a substantial burden for\npatients; yet there are currently no approved therapies that specifically\naddress the fibrotic component of the disease. NOV-ERA is designed to evaluate\nthe efficacy and safety of ontunisertib and to provide important data across\nmultiple imaging modalities, clinical endpoints, and patient-reported\noutcomes. We are grateful to the patients, investigators and clinical sites\nparticipating in this global study.”\n\nThe initiation of the NOV-ERA study triggers a €7 million milestone payment\nto the former shareholders of Origo Biopharma under the terms of Agomab's 2021\nacquisition of the company. The acquisition included up to €20 million in\npotential development and regulatory milestone payments. To date, €10\nmillion has become payable, including a €3 million milestone paid in 2025,\nreflecting continued progress in the development of the program.\n\nOntunisertib is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout NOV-ERA\nThe 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 patients diagnosed with symptomatic ileal strictures. The\ntrial is expected to enroll approximately 320 adult patients globally. To be\neligible for the trial, participants must have at least one naive or\nanastomotic endoscopically non-passable ileal stricture, confirmed by central\nreading. Upon study initiation, participants will be randomized in a 1:1:1:1\nratio to receive either ontunisertib at one of three dose levels (400 mg, 200\nmg, and 100 mg), or a matching placebo, administered twice daily (BID). The\ntrial will consist of a 6-week screening period, a 52-week treatment period,\nand a 2-week follow-up period. The primary endpoint is the proportion of\npatients achieving endoscopic passability of the ileal index stricture at Week\n24.\n\nKey secondary efficacy endpoints include: \n* Proportion of participants achieving endoscopic passability of the ileal\nindex stricture at Week 52.\n* Time to an FSCD-related event (including bowel surgery and endoscopic\nballoon dilation).\n* Change from baseline in Magnetic Resonance Enterography (MRE) imaging\nfeatures of the index stricture at Week 24 and Week 52.\n* Change from baseline in total SES-CD at Week 24 and Week 52.\n* Proportion of participants with an endoscopic response and remission at Week\n24 and Week 52 compared to baseline.\n* Change from baseline in Patient-Reported Outcome questionnaire for\nstricturing Crohn’s disease (S-PRO 2.0) severity score, Crohn’s disease\nactivity index (CDAI) and quality of life instruments at Week 24 and Week 52.\nThe endpoints assessed in the NOV-ERA study are designed to inform the\nselection of potential registrational endpoints for ontunisertib in FSCD.\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, the expected conduct and\nprogress of the NOV-ERA Phase 2b study, and our interactions with regulatory\nauthorities. Forward-looking statements are based on Agomab’s current\nexpectations and are subject to inherent uncertainties, risks and assumptions\nthat are difficult to predict. Factors that could cause actual results to\ndiffer include, but are not limited to, risks and uncertainties related to the\nresults of our clinical trials; expectations regarding the inherent\nuncertainties associated with the development of novel drug therapies;\npreclinical and clinical trial and product development activities and\nregulatory approval requirements for product candidates; the impact of\ngovernmental laws and regulations on our business; and disruptions caused by\nour reliance on third party suppliers and service providers. These and other\nrisks and uncertainties are described more fully in our filings and reports\nwith the SEC, including in our most recent annual report on Form 20‐F filed\nwith the SEC and our subsequent filings and reports filed with the SEC.\nForward-looking statements contained in this announcement are made as of this\ndate, and Agomab undertakes no duty to update such information except as\nrequired under applicable law. Readers should not rely upon the information in\nthis announcement as current or accurate 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","article_body_html":"","raw_payload":{"data":{"id":"nGNE2nyywB-20261013","title":"Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease","author":"Globe Newswire","ticker":"AGMB","created":"2026-10-13T20:05:00.059Z","tickers":["AGMB"],"exchange":"NASDAQ","article_body":"-- NOV-ERA is designed to assess the efficacy and safety of ontunisertib in\napproximately 320 patients with symptomatic Fibrostenosing Crohn's disease\n(FSCD) --\n\n-- Global, randomized, placebo-controlled, dose-ranging study to evaluate\nthree dose levels of ontunisertib, with endoscopic passability at Week 24 as\nprimary endpoint --\n\n-- Study initiation represents an important milestone in the development of\nontunisertib as a potential first targeted anti-fibrotic treatment for FSCD --\n\nAntwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=KXIid1wKoQtljNCQSys1L2yvpOBQhwbO3NvB4mxayrqzRY6Z-fS75HmiH9IMfnKUzfEg3ZH6N606ino9ZiZDMvNSqD8eBHwwVMKK-ES1Xs4=)\n(‘Agomab’), a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced that the first patient has been dosed in\nNOV-ERA, the Company's global Phase 2b study evaluating ontunisertib in\npatients with symptomatic FSCD.\n\nNOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase\n2b study designed to assess the safety and efficacy of ontunisertib. The study\nis expected to enroll approximately 320 adult patients globally. Participants\nwill be randomized to receive either ontunisertib at one of three dose levels\n(400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a\ntreatment duration of 52 weeks.\n\nThe initiation of NOV-ERA follows the positive Phase 2a STENOVA results that\nsupport continued clinical development of ontunisertib in FSCD. The recently\nannounced positive long-term safety and tolerability findings of the\nopen-label extension (OLE) part of the STENOVA Phase 2a study provide strong\nsupport for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.\n\nPhilippe Wiesel, Chief Medical Officer of Agomab, commented: “Dosing the\nfirst patient in NOV-ERA marks the beginning of an exciting next chapter for\nour Company and for the late-stage development of ontunisertib. FSCD is\nassociated with progressive bowel damage and a substantial burden for\npatients; yet there are currently no approved therapies that specifically\naddress the fibrotic component of the disease. NOV-ERA is designed to evaluate\nthe efficacy and safety of ontunisertib and to provide important data across\nmultiple imaging modalities, clinical endpoints, and patient-reported\noutcomes. We are grateful to the patients, investigators and clinical sites\nparticipating in this global study.”\n\nThe initiation of the NOV-ERA study triggers a €7 million milestone payment\nto the former shareholders of Origo Biopharma under the terms of Agomab's 2021\nacquisition of the company. The acquisition included up to €20 million in\npotential development and regulatory milestone payments. To date, €10\nmillion has become payable, including a €3 million milestone paid in 2025,\nreflecting continued progress in the development of the program.\n\nOntunisertib is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout NOV-ERA\nThe 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 patients diagnosed with symptomatic ileal strictures. The\ntrial is expected to enroll approximately 320 adult patients globally. To be\neligible for the trial, participants must have at least one naive or\nanastomotic endoscopically non-passable ileal stricture, confirmed by central\nreading. Upon study initiation, participants will be randomized in a 1:1:1:1\nratio to receive either ontunisertib at one of three dose levels (400 mg, 200\nmg, and 100 mg), or a matching placebo, administered twice daily (BID). The\ntrial will consist of a 6-week screening period, a 52-week treatment period,\nand a 2-week follow-up period. The primary endpoint is the proportion of\npatients achieving endoscopic passability of the ileal index stricture at Week\n24.\n\nKey secondary efficacy endpoints include: \n* Proportion of participants achieving endoscopic passability of the ileal\nindex stricture at Week 52.\n* Time to an FSCD-related event (including bowel surgery and endoscopic\nballoon dilation).\n* Change from baseline in Magnetic Resonance Enterography (MRE) imaging\nfeatures of the index stricture at Week 24 and Week 52.\n* Change from baseline in total SES-CD at Week 24 and Week 52.\n* Proportion of participants with an endoscopic response and remission at Week\n24 and Week 52 compared to baseline.\n* Change from baseline in Patient-Reported Outcome questionnaire for\nstricturing Crohn’s disease (S-PRO 2.0) severity score, Crohn’s disease\nactivity index (CDAI) and quality of life instruments at Week 24 and Week 52.\nThe endpoints assessed in the NOV-ERA study are designed to inform the\nselection of potential registrational endpoints for ontunisertib in FSCD.\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, the expected conduct and\nprogress of the NOV-ERA Phase 2b study, and our interactions with regulatory\nauthorities. Forward-looking statements are based on Agomab’s current\nexpectations and are subject to inherent uncertainties, risks and assumptions\nthat are difficult to predict. Factors that could cause actual results to\ndiffer include, but are not limited to, risks and uncertainties related to the\nresults of our clinical trials; expectations regarding the inherent\nuncertainties associated with the development of novel drug therapies;\npreclinical and clinical trial and product development activities and\nregulatory approval requirements for product candidates; the impact of\ngovernmental laws and regulations on our business; and disruptions caused by\nour reliance on third party suppliers and service providers. These and other\nrisks and uncertainties are described more fully in our filings and reports\nwith the SEC, including in our most recent annual report on Form 20‐F filed\nwith the SEC and our subsequent filings and reports filed with the SEC.\nForward-looking statements contained in this announcement are made as of this\ndate, and Agomab undertakes no duty to update such information except as\nrequired under applicable law. Readers should not rely upon the information in\nthis announcement as current or accurate 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"},"type":"article","timestamp":"2026-10-13T20:05:00.172870063Z","server_sent_at_ms":1791921900172},"received_at":"2026-10-13T20:05:00.304Z","source_url":null},"analysis":{"id":"156418","press_release_id":"168126","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["milestone payment obligations to former Origo shareholders add cash outflows as the program advances"],"eventType":"clinical_trial","narrative":"Agomab dosed the first patient in NOV-ERA, a global Phase 2b study of ontunisertib in fibrostenosing Crohn's disease, expected to enroll roughly 320 patients.\n\nThe randomized, placebo-controlled, dose-ranging trial tests 400 mg, 200 mg, and 100 mg BID doses over 52 weeks, with endoscopic passability at Week 24 as the primary endpoint.\n\nThe initiation follows positive Phase 2a STENOVA results and triggers a €7 million milestone payment tied to the 2021 Origo Biopharma acquisition; the drug holds FDA Fast Track Designation.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Pipeline progression for lead anti-fibrotic -- enrollment and Week 24 passability data are the catalysts to watch."},"keyFigures":{"drugName":"ontunisertib (AGMB-129)","phaseOfTrial":"Phase 2b","customDimensions":{"planned_enrollment":320,"milestone_payment_eur":"€7 million","treatment_duration_weeks":52,"milestones_paid_to_date_eur":"€10 million","total_potential_milestones_eur":"€20 million"}},"quotedText":"Dosing the first patient in NOV-ERA marks the beginning of an exciting next chapter for our Company and for the late-stage development of ontunisertib.","namedEntities":{"people":[{"name":"Philippe Wiesel","role":"Chief Medical Officer"},{"name":"Sofie Van Gijsel","role":"VP of Investor Relations"}],"products":["ontunisertib (AGMB-129)"],"companies":[{"name":"Agomab Therapeutics NV","ticker":"AGMB"},{"name":"Origo Biopharma","relationship":"acquired company (2021)"}],"dollarAmounts":[{"amount":"€7 million","context":"milestone payment triggered by NOV-ERA initiation"},{"amount":"€20 million","context":"total potential development/regulatory milestones under 2021 Origo acquisition"},{"amount":"€10 million","context":"milestones payable to date"},{"amount":"€3 million","context":"milestone paid in 2025"}]},"materialImpact":{"score":2,"reasoning":"First-patient-dosed milestone for the lead asset's Phase 2b study is a routine pipeline progression event, not a readout or regulatory binary. Data are far off (~52-week treatment plus enrollment time)."},"tickerRelevance":{"others":[],"primary":"AGMB"},"globalImportance":25,"audienceRelevance":20,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap-biotech","eventGravity":"routine-clinical-trial-milestone","dataReadoutTiming":"remote (enrollment + 52-week treatment)"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Agomab dosed the first patient in NOV-ERA, a global Phase 2b study of ontunisertib in fibrostenosing Crohn's disease, expected to enroll roughly 320 patients.\n\nThe randomized, placebo-controlled, dose-ranging trial tests 400 mg, 200 mg, and 100 mg BID doses over 52 weeks, with endoscopic passability at Week 24 as the primary endpoint.\n\nThe initiation follows positive Phase 2a STENOVA results and triggers a €7 million milestone payment tied to the 2021 Origo Biopharma acquisition; the drug holds FDA Fast Track Designation.","key_figures":{"drugName":"ontunisertib (AGMB-129)","phaseOfTrial":"Phase 2b","customDimensions":{"planned_enrollment":320,"milestone_payment_eur":"€7 million","treatment_duration_weeks":52,"milestones_paid_to_date_eur":"€10 million","total_potential_milestones_eur":"€20 million"}},"named_entities":{"people":[{"name":"Philippe Wiesel","role":"Chief Medical Officer"},{"name":"Sofie Van Gijsel","role":"VP of Investor Relations"}],"products":["ontunisertib (AGMB-129)"],"companies":[{"name":"Agomab Therapeutics NV","ticker":"AGMB"},{"name":"Origo Biopharma","relationship":"acquired company (2021)"}],"dollarAmounts":[{"amount":"€7 million","context":"milestone payment triggered by NOV-ERA initiation"},{"amount":"€20 million","context":"total potential development/regulatory milestones under 2021 Origo acquisition"},{"amount":"€10 million","context":"milestones payable to date"},{"amount":"€3 million","context":"milestone paid in 2025"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-13T20:05:05.393Z","global_importance":25,"audience_relevance":20,"importance_components":{"tickerTier":"small-cap-biotech","eventGravity":"routine-clinical-trial-milestone","dataReadoutTiming":"remote (enrollment + 52-week treatment)"}},"durationMs":5051,"modelName":"glm-5.3-flashx"}}