AgomAb Therapeutics NV

AGMB

Börsenwert 408 Mio. $

Agomab announced that the first patient has been dosed in NOV-ERA, the Company's Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.

AgomAb Therapeutics NV (AGMB) Discusses Open-Label Extension Results of Phase IIa STENOVA Study in Fibrosing Crohn's Disease Transcript

Agomab Therapeutics NV (NASDAQ:AGMB) reported results from the 48-week open-label extension portion of its Phase 2a STENOVA trial of ontunisertib for fibrostenotic Crohn's disease.

-- Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn's disease (FSCD) patients -- -- Low annualized FSCD-related event rate of 3%, with one endoscopic balloon dilation (EBD) and no surgeries reported over the full treatment period -- -- Radiological assessment shows trend for fibrotic stricture stabilization over treatment course -- -- Sustained disease control observed across symptoms and disease activity scores in Open-Label Extension Study (OLE) -- -- Results support initiation of global NOV-ERA Phase 2b study in FSCD in the coming months -- -- Company to host webcast today at 8:30 a.m. Eastern Time -- Antwerp, Belgium, October 1, 2026 – Agomab Therapeutics NV (‘Agomab') a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures.

Agomab Therapeutics targets fibrotic strictures in Crohn's disease, aiming to create a new treatment category rather than compete with existing therapies. AGMB's ontunisertib showed promising endoscopic results and safety in Phase 2a, with further validation needed in larger, controlled trials. Strong funding runway through 2029 and disciplined R&D execution support AGMB's ability to advance clinical programs without immediate dilution risk.

-- Topline Phase 1 data shows generally favorable safety and tolerability profile of AGMB-447 -- -- Pharmacokinetic profile confirms efficient lung restriction with low systemic exposure and high exposure of AGMB-447 in the lung, in line with prior results observed in healthy participants -- -- Robust target engagement of ALK5 observed with AGMB-447 in IPF patients -- -- Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients submitted; Company intends to initiate study before year-end -- Antwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV (‘Agomab'), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the Phase 1 study of AGMB-447 in IPF patients. AGMB-447 is an investigational inhaled lung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).1 The Phase 1 study of AGMB-447 is a three-part, double-blind, randomized, placebo-controlled single ascending dose (SAD; Part A; dose range: 1 mg QD (once daily) to 20 mg QD) and multiple ascending dose (MAD; Part B; dose range: 1 mg QD to 6 mg BID (twice daily)) study in healthy participants and multiple dose study in IPF patients (Part C; dose range: 4.5 mg BID to 6 mg BID).

Agomab announced shareholders approved all resolutions submitted for consideration at the Company's Special and Extraordinary General Shareholders' Meeting

Antwerp, Belgium, September 3, 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 investor conferences: Citi's 2026 Biopharma Back to School Conference. Thursday, September 10, 2026 in New York, NY.

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-- 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 TGF-β 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.