Agomab IPO Raises $200M to Fund Fibrosis Therapies

Agomab Therapeutics NV has closed its IPO, raising approximately $200 million to support the development of therapies for fibrotic diseases.

The clinical-stage biopharma offered 12.5 million American Depositary Shares (ADS) at $16 per share. The ADSs began trading on the Nasdaq Global Select Market on February 6 under the ticker symbol AGMB, with the offering closing on February 9.

Agomab develops therapies for immunology and inflammatory diseases, with an initial focus on fibrosis. The company is headquartered in Antwerp, Belgium, with chemistry laboratories in Touro, Spain and a US presence in Cambridge, Massachusetts.

Its research programs target biological pathways involved in fibrosis, particularly transforming growth factor beta (TGFβ) signaling, which plays a central role in tissue scarring.

The company’s lead program, ontunisertib, is an oral small-molecule inhibitor of the TGFβ receptor ALK5 being developed for fibrostenosing Crohn’s disease. The condition is a complication of Crohn’s disease characterized by fibrotic narrowing of the intestine that can lead to obstructive symptoms and often requires surgical intervention. 

Ontunisertib is designed to act locally in the gastrointestinal tract while limiting systemic exposure. After absorption, the drug is rapidly metabolized in the liver to reduce potential toxicities linked to broader inhibition of the TGFβ pathway.

The program has been evaluated in the STENOVA Phase IIa trial, a randomized, double-blind, placebo-controlled study involving 103 patients with symptomatic fibrostenosing Crohn’s disease and intestinal strictures.

The trial met its primary endpoint of evaluating safety and tolerability, with adverse events balanced across treatment groups and placebo. Pharmacokinetic results confirmed the drug’s gastrointestinal-restricted profile, with high local exposure in intestinal tissue and low systemic exposure. Signals were also observed across several exploratory clinical endpoints.

A 48-week open-label extension of the STENOVA trial is currently ongoing, with results expected in the second half of 2026. Agomab also plans to initiate a Phase IIb trial of ontunisertib in fibrostenosing Crohn’s disease during the same period.

The FDA granted Fast Track designation to ontunisertib in 2023 for the treatment of fibrostenosing Crohn’s disease.

Agomab’s second clinical-stage candidate, AGMB-447, is an inhaled small-molecule inhibitor of the ALK5 receptor being developed for idiopathic pulmonary fibrosis (IPF). The condition is characterized by progressive scarring of lung tissue that gradually impairs respiratory function.

AGMB-447 is delivered by inhalation to target lung tissue directly. The molecule is designed to be rapidly inactivated after entering the bloodstream to limit systemic exposure while maintaining activity in the lung.

The therapy is currently being evaluated in a randomized Phase I trial assessing safety, pharmacokinetics, pharmacodynamics and target engagement. The study has enrolled 108 healthy participants in single- and multiple-dose cohorts and has begun enrolling patients with IPF. Data from the patient cohort are expected in the second half of 2026.

Agomab is also advancing a discovery pipeline that includes AGMB-101, a monoclonal antibody designed to mimic hepatocyte growth factor and activate the MET receptor. In preclinical studies, the program has demonstrated antifibrotic and regenerative activity and has received regulatory clearance to proceed with a Phase I single ascending dose study in healthy participants and patients with liver cirrhosis.

Ontunisertib and AGMB-447 entered Agomab’s pipeline through the company’s 2021 acquisition of Origo Biopharma, a biotechnology company developing organ-restricted small-molecule drug candidates targeting the TGFβ pathway for fibrotic diseases.

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Across clinical updates in Crohn’s disease, AbbVie revealed positive topline results from the Phase III AFFIRM trial evaluating subcutaneous induction treatment with risankizumab (Skyrizi) in adults with moderately to severely active Crohn’s disease. More patients receiving risankizumab achieved clinical remission and endoscopic response at Week 12 compared with placebo. Eli Lilly shared long-term results from the Phase III VIVID-2 extension study of mirikizumab in Crohn’s disease. Many patients who achieved steroid-free remission maintained remission through three years of treatment.

In the larger fibrotic disease space, PureTech Health said the FDA and European Commission granted Orphan Drug designation to deupirfenidone, an investigational antifibrotic therapy for IPF. Separately, Mirador Therapeutics is advancing multiple clinical programs targeting immune-mediated inflammatory and fibrotic diseases following a $250 million Series B financing completed in 2025.

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