AgomAb Therapeutics（AGMB）株式概要AgomAb Therapeutics NVは臨床段階にあるバイオ医薬品企業で、米国において免疫学および炎症性疾患の新規疾患修飾療法を開発している。 詳細AGMB ファンダメンタル分析スノーフレーク・スコア評価1/6将来の成長0/6過去の実績0/6財務の健全性6/6配当金0/6報酬アナリストらは、株価が142.2%上昇するだろうとほぼ一致している。 リスク分析今後3年間の収益は年平均15.5%減少すると予測されている。 収益が 100 万ドル未満 ( €0 )現在は利益が出ておらず、今後3年間で利益が出る見込みはない US市場と比較した過去 3 か月間の株価の変動すべてのリスクチェックを見るAGMB Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW499,106 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG499,106 investors already sharing narrativesYour Fair ValueUS$Current PriceUS$13.52該当なし内在価値ディスカウントEst. Revenue$PastFuture-78m12016201920222025202620282031Revenue €1.0Earnings €0.1AdvancedSet Fair ValueView all narrativesAgomAb Therapeutics NV 競合他社SpyGlass PharmaSymbol: NasdaqGS:SGPMarket cap: US$640.2mRelmada TherapeuticsSymbol: NasdaqCM:RLMDMarket cap: US$658.7mCorMedixSymbol: NasdaqGM:CRMDMarket cap: US$686.5mContineum TherapeuticsSymbol: NasdaqGS:CTNMMarket cap: US$564.5m価格と性能株価の高値、安値、推移の概要AgomAb Therapeutics過去の株価現在の株価US$13.5252週高値US$17.8252週安値US$8.75ベータ01ヶ月の変化36.29%3ヶ月変化28.64%1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化-7.71%最新ニュースお知らせ • Jun 24Agomab Therapeutics NV Announces Design Of NOV-ERA Phase 2b Study With Ontunisertib In Fibrostenosing Crohn’s DiseaseAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-ß RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. The Company has aligned with the FDA on the study design of NOV-ERA, including the study’s primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. In addition, the study has received approval by Health Canada. The Company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The Company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD). Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24. Key secondary efficacy endpoints include: Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52. Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52. Change from baseline in total SES-CD at Week 24 and Week 52. Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline. Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score at Week 24 and Week 52. Time to an FSCD-related event (including surgery and endoscopic balloon dilation). The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD. Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-ß RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-ß is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-ß in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation. Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.Seeking Alpha • Jun 04AgomAb Therapeutics: High Risk, High Reward StockSummary AgomAb Therapeutics offers high-risk, high-reward potential driven by two late-stage immunology drugs targeting large addressable markets. AGMB-129 (Crohn's disease) and AGMB-447 (IPF) have Fast Track and Orphan Drug designations, indicating significant unmet need and regulatory advantages. Strong backing from major pharma players and a high institutional ownership position, AGOM is a potential acquisition target upon successful trial outcomes. Successful phase 2/3 trials could unlock billions in revenue, but risks include low insider ownership and lock-up period expiry. Read the full article on Seeking Alphaお知らせ • Apr 27AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026, at 16:00 Romance Standard Time. Location: posthoflei 1 box 6, 2600, antwerp (berchem), BelgiumBoard Change • Feb 18High number of new and inexperienced directorsThere are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Non-Executive Independent Director Ohad Hammer is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Feb 06AgomAb Therapeutics NV has completed an IPO in the amount of $200 million.AgomAb Therapeutics NV has completed an IPO in the amount of $200 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 12,500,000 Price\Range: $16 Discount Per Security: $1.12最新情報をもっと見るRecent updatesお知らせ • Jun 24Agomab Therapeutics NV Announces Design Of NOV-ERA Phase 2b Study With Ontunisertib In Fibrostenosing Crohn’s DiseaseAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-ß RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. The Company has aligned with the FDA on the study design of NOV-ERA, including the study’s primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. In addition, the study has received approval by Health Canada. The Company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The Company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD). Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24. Key secondary efficacy endpoints include: Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52. Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52. Change from baseline in total SES-CD at Week 24 and Week 52. Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline. Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score at Week 24 and Week 52. Time to an FSCD-related event (including surgery and endoscopic balloon dilation). The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD. Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-ß RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-ß is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-ß in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation. Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.Seeking Alpha • Jun 04AgomAb Therapeutics: High Risk, High Reward StockSummary AgomAb Therapeutics offers high-risk, high-reward potential driven by two late-stage immunology drugs targeting large addressable markets. AGMB-129 (Crohn's disease) and AGMB-447 (IPF) have Fast Track and Orphan Drug designations, indicating significant unmet need and regulatory advantages. Strong backing from major pharma players and a high institutional ownership position, AGOM is a potential acquisition target upon successful trial outcomes. Successful phase 2/3 trials could unlock billions in revenue, but risks include low insider ownership and lock-up period expiry. Read the full article on Seeking Alphaお知らせ • Apr 27AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026, at 16:00 Romance Standard Time. Location: posthoflei 1 box 6, 2600, antwerp (berchem), BelgiumBoard Change • Feb 18High number of new and inexperienced directorsThere are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Non-Executive Independent Director Ohad Hammer is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Feb 06AgomAb Therapeutics NV has completed an IPO in the amount of $200 million.AgomAb Therapeutics NV has completed an IPO in the amount of $200 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 12,500,000 Price\Range: $16 Discount Per Security: $1.12株主還元AGMBUS PharmaceuticalsUS 市場7D-24.1%-1.3%0.8%1Yn/a47.9%20.2%株主還元を見る業界別リターン: AGMBがUS Pharmaceuticals業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: AGMB US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is AGMB's price volatile compared to industry and market?AGMB volatilityAGMB Average Weekly Movement15.7%Pharmaceuticals Industry Average Movement9.2%Market Average Movement7.3%10% most volatile stocks in US Market16.7%10% least volatile stocks in US Market3.2%安定した株価: AGMBの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のAGMBのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト201762Tim Knotneruswww.agomab.comAgomAb Therapeutics NVは臨床段階にあるバイオ医薬品企業で、米国において免疫学および炎症性疾患の新規疾患修飾療法を開発しています。同社の製品パイプラインには、第2a相臨床試験段階にある線維性クローン病治療用の経口消化管制限型低分子ALK5またはTGFßR1阻害剤Ontunisertib（AGMB-129）、第1相臨床試験段階にある特発性肺線維症治療用の吸入型低分子ALK5またはTGFßR1阻害剤AGMB-447などがある。また、MET受容体の作動または刺激により作用するHGF模倣モノクローナル抗体AGMB-101も開発しており、前臨床モデルで抗線維化活性と再生活性を実証している。同社は2017年に法人化され、ベルギーのアントワープに本社を置いている。もっと見るAgomAb Therapeutics NV 基礎のまとめAgomAb Therapeutics の収益と売上を時価総額と比較するとどうか。AGMB 基礎統計学時価総額US$622.99m収益（TTM）-US$88.67m売上高(TTM)n/a0.0xP/Sレシオ-7.5xPER（株価収益率AGMB は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計AGMB 損益計算書（TTM）収益€0売上原価€0売上総利益€0その他の費用€77.50m収益-€77.50m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-1.57グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0%AGMB の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/06 07:02終値2026/07/06 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋AgomAb Therapeutics NV 3 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。4 アナリスト機関Patrick TrucchioH.C. Wainwright & Co.Anupam RamaJ.P. MorganThomas SmithLeerink Partners LLC1 その他のアナリストを表示
お知らせ • Jun 24Agomab Therapeutics NV Announces Design Of NOV-ERA Phase 2b Study With Ontunisertib In Fibrostenosing Crohn’s DiseaseAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-ß RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. The Company has aligned with the FDA on the study design of NOV-ERA, including the study’s primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. In addition, the study has received approval by Health Canada. The Company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The Company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD). Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24. Key secondary efficacy endpoints include: Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52. Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52. Change from baseline in total SES-CD at Week 24 and Week 52. Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline. Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score at Week 24 and Week 52. Time to an FSCD-related event (including surgery and endoscopic balloon dilation). The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD. Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-ß RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-ß is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-ß in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation. Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.
Seeking Alpha • Jun 04AgomAb Therapeutics: High Risk, High Reward StockSummary AgomAb Therapeutics offers high-risk, high-reward potential driven by two late-stage immunology drugs targeting large addressable markets. AGMB-129 (Crohn's disease) and AGMB-447 (IPF) have Fast Track and Orphan Drug designations, indicating significant unmet need and regulatory advantages. Strong backing from major pharma players and a high institutional ownership position, AGOM is a potential acquisition target upon successful trial outcomes. Successful phase 2/3 trials could unlock billions in revenue, but risks include low insider ownership and lock-up period expiry. Read the full article on Seeking Alpha
お知らせ • Apr 27AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026, at 16:00 Romance Standard Time. Location: posthoflei 1 box 6, 2600, antwerp (berchem), Belgium
Board Change • Feb 18High number of new and inexperienced directorsThere are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Non-Executive Independent Director Ohad Hammer is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Feb 06AgomAb Therapeutics NV has completed an IPO in the amount of $200 million.AgomAb Therapeutics NV has completed an IPO in the amount of $200 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 12,500,000 Price\Range: $16 Discount Per Security: $1.12
お知らせ • Jun 24Agomab Therapeutics NV Announces Design Of NOV-ERA Phase 2b Study With Ontunisertib In Fibrostenosing Crohn’s DiseaseAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-ß RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. The Company has aligned with the FDA on the study design of NOV-ERA, including the study’s primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. In addition, the study has received approval by Health Canada. The Company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The Company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD). Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24. Key secondary efficacy endpoints include: Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52. Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52. Change from baseline in total SES-CD at Week 24 and Week 52. Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline. Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score at Week 24 and Week 52. Time to an FSCD-related event (including surgery and endoscopic balloon dilation). The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD. Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-ß RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-ß is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-ß in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation. Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.
Seeking Alpha • Jun 04AgomAb Therapeutics: High Risk, High Reward StockSummary AgomAb Therapeutics offers high-risk, high-reward potential driven by two late-stage immunology drugs targeting large addressable markets. AGMB-129 (Crohn's disease) and AGMB-447 (IPF) have Fast Track and Orphan Drug designations, indicating significant unmet need and regulatory advantages. Strong backing from major pharma players and a high institutional ownership position, AGOM is a potential acquisition target upon successful trial outcomes. Successful phase 2/3 trials could unlock billions in revenue, but risks include low insider ownership and lock-up period expiry. Read the full article on Seeking Alpha
お知らせ • Apr 27AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026, at 16:00 Romance Standard Time. Location: posthoflei 1 box 6, 2600, antwerp (berchem), Belgium
Board Change • Feb 18High number of new and inexperienced directorsThere are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Non-Executive Independent Director Ohad Hammer is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Feb 06AgomAb Therapeutics NV has completed an IPO in the amount of $200 million.AgomAb Therapeutics NV has completed an IPO in the amount of $200 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 12,500,000 Price\Range: $16 Discount Per Security: $1.12
