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Form 6-K Agomab Therapeutics NV For: Jun 23

Tue, 23 Jun 2026 16:14:00 -0400

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Agomab outlines Phase 2b trial design for Crohn's disease drug

Tue, 23 Jun 2026 16:05:15 -0400

Agomab Therapeutics NV (Nasdaq: AGMB) has announced the design of its NOV-ERA Phase 2b study evaluating ontunisertib in patients with Fibrostenosing Crohn's Disease (FSCD), according to a company press release.

The company said it has aligned with the U.S. Food and Drug Administration on key elements of the study design, including a primary efficacy endpoint of endoscopic passability at Week 24, assessed by the SES-CD narrowing score. The protocol has been submitted to the FDA and has cleared central Institutional Review Board approval in the U.S. Health Canada has also approved the study, and Clinical Trial Applications have been submitted in

Agomab Announces Design of NOV-ERA Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease

Tue, 23 Jun 2026 16:05:00 -0400

-- Regulatory alignment with U.S. Food and Drug Administration (FDA) on key elements of NOV-ERA Phase 2b study design, including novel primary endpoint of endoscopic passability --

-- Study initiation on track, with first participants expected to be dosed in the second half of 2026 --

Antwerp, Belgium, June 23, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab” or the “Company”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today 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

Agomab Announces Design of NOV-ERA Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease

Tue, 23 Jun 2026 16:05:00 -0400

-- Regulatory alignment with U.S. Food and Drug Administration (FDA) on key elements of NOV-ERA Phase 2b study design, including novel primary endpoint of endoscopic passability --

-- Study initiation on track, with first participants expected to be dosed in the second half of 2026 --

H.C. Wainwright Starts Agomab Therapeutics (AGMB) at Buy

Mon, 22 Jun 2026 06:11:58 -0400

(Updated - June 22, 2026 6:11 AM EDT)

H.C. Wainwright analyst Patrick Trucchio initiates coverage on Agomab Therapeutics (NASDAQ: AGMB) with a Buy rating and a price target of $35.00.

The analyst commented: "Pipeline includes multiple organ-restricted inhibitors of the TGF-β/ALK5 axis, a well-validated antifibrotic target that has historically been undruggable due to dose-limiting cardiac valve toxicity. Both of Agomab's clinical programs are engineered to achieve high local concentrations in the diseased organ while being rapidly inactivated upon systemic absorption, capturing the antifibrotic potential of ALK5 in both fibrostenosing Crohn's disease (FSCD) and idiopathic pulmonary fibrosis (IPF) while avoiding the systemic safety

H.C. Wainwright Starts Agomab Therapeutics (AGMB) at Buy

Mon, 22 Jun 2026 06:11:58 -0400

(Updated - June 22, 2026 6:11 AM EDT)

H.C. Wainwright analyst Patrick Trucchio initiates coverage on Agomab Therapeutics (NASDAQ: AGMB) with a Buy rating and a price target of $35.00.

Form 6-K Agomab Therapeutics NV For: May 27

Wed, 27 May 2026 07:12:00 -0400

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Agomab Announces Results of Annual General Meeting

Wed, 27 May 2026 05:00:00 -0400

Antwerp, Belgium, May 27, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced the results of its Annual General Meeting (AGM) held on Tuesday, May 26, 2026.

All items on the agenda were approved, including:

Approval of the statutory financial statements for the financial year ended December 31, 2025.
Discharge to the current and former members of the Board of Directors and the statutory auditor in respect of the performance of their respective duties during the financial year ending on December 31, 2025.
Reappointment of Mr. Ohad

Agomab Announces Results of Annual General Meeting

Wed, 27 May 2026 05:00:00 -0400

Approval of the statutory financial statements for the financial year ended December 31, 2025.
Discharge to the current and former members of the Board of Directors and the statutory auditor in respect of the performance of their respective duties during the financial year ending on December 31, 2025.
Reappointment of Mr. Ohad

Agomab Announces Results of Annual General Meeting

Wed, 27 May 2026 05:00:00 -0400

Approval of the statutory financial statements for the financial year ended December 31, 2025.
Discharge to the current and former members of the Board of Directors and the statutory auditor in respect of the performance of their respective duties during the financial year ending on December 31, 2025.
Reappointment of Mr. Ohad Hammer as

Agomab Announces Results of Annual General Meeting

Wed, 27 May 2026 05:00:00 -0400

Approval of the statutory financial statements for the financial year ended December 31, 2025.
Discharge to the current and former members of the Board of Directors and the statutory auditor in respect of the performance of their respective duties during the financial year ending on December 31, 2025.
Reappointment of Mr. Ohad Hammer as

Form SCHEDULE 13G Agomab Therapeutics NV Filed by: Redmile Group, LLC

Fri, 15 May 2026 16:49:00 -0400

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Form SCHEDULE 13G Agomab Therapeutics NV Filed by: Cormorant Asset Management, LP

Fri, 15 May 2026 13:15:00 -0400

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Agomab to Participate in Upcoming Conferences

Thu, 14 May 2026 07:30:00 -0400

Antwerp, Belgium, May 14, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that members of the management team will participate in the following upcoming industry and investor conferences:

ATS International Conference 2026. Poster Board #904 titled ‘AGMB-447, an Inhaled Lung-Restricted TGFβR1/ALK5 Inhibitor Intended for the Treatment of Idiopathic Pulmonary Fibrosis, Shows Robust Anti-Fibrotic Activity and Target Engagement in Preclinical Species and Healthy Subjects’ on Wednesday, May 20, 2026 at 8:15 AM ET in Orlando, FL.
H.C. Wainwright 4th Annual BioConnect Investor Conference at

Agomab to Participate in Upcoming Conferences

Thu, 14 May 2026 07:30:00 -0400

Antwerp, Belgium, May 14, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that members of the management team will participate in the following upcoming industry and investor conferences:

ATS International Conference 2026. Poster Board #904 titled ‘AGMB-447, an Inhaled Lung-Restricted TGFβR1/ALK5 Inhibitor Intended for the Treatment of Idiopathic Pulmonary Fibrosis, Shows Robust Anti-Fibrotic Activity and Target Engagement in Preclinical Species and Healthy Subjects’ on Wednesday, May 20, 2026 at 8:15 AM ET in Orlando, FL.

H.C. Wainwright 4th Annual BioConnect Investor Conference at

Form SCHEDULE 13G Agomab Therapeutics NV Filed by: Sanofi

Wed, 06 May 2026 06:08:00 -0400
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Form 6-K Agomab Therapeutics NV For: Apr 24

Fri, 24 Apr 2026 16:22:00 -0400
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Form 20-F Agomab Therapeutics NV For: Dec 31

Thu, 23 Apr 2026 18:56:00 -0400

http://archive.fast-edgar.com/20260423/AOB23G2C8Z22EZZZ279D2ZZZTWCOR2X2Z282

Filed on: April 23, 2026

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Agomab Reports Full Year 2025 Financial Results and Confirms 2026 Outlook

Thu, 23 Apr 2026 18:14:00 -0400

-- Cash and Cash Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --

-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD) --

-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --

-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA

Form SCHEDULE 13G Agomab Therapeutics NV Filed by: Pontifax Management 4 G.P. (2015) Ltd.

Thu, 16 Apr 2026 09:14:00 -0400
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