AgomAb Therapeutics NVAGMB

NasdaqHealthcareBiological Products, (No Diagnostic Substances)

Price (close)

$10.51

Market cap

$517.6M

P/E

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Revenue (FY)

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Dividend yield

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1-year total return

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What AgomAb Therapeutics NV does.

Agomab is a clinical-stage biopharmaceutical company focused on developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need. Agomab’s product candidates are designed to target established potent pathways and utilize organ-restricted approaches, with the aim of increasing efficacy while minimizing safety liabilities. Fostering a culture of excellence, Agomab’s mission is to pioneer therapeutics that aim to resolve fibro-inflammation and restore organ function to enable people with these disorders to live fuller and healthier lives.

We are advancing a pipeline of novel product candidates for chronic fibro-inflammatory disorders with well-validated targets, significant unmet medical needs and large commercial potential. Our pipeline includes:

● Ontunisertib (AGMB-129): Our lead product candidate, ontunisertib (AGMB-129), is a selective and potent oral, gastrointestinal-restricted small molecule inhibitor of ALK5, or TGFβR1, in development for the treatment of Fibrostenosing Crohn’s Disease, or FSCD. FSCD is a severe complication of Crohn’s Disease, or CD, that is associated with significant morbidity. There are approximately 1.4 million patients under treatment for CD in the seven major markets of the United States, France, Germany, Italy, Spain, the United Kingdom and Japan, and approximately 620,000, or 46%, of these patients have FSCD. The emergence of burdensome symptomatic strictures is considered to be an inevitable consequence of long-term inflammation for the large proportion of patients with CD who progress to FSCD and eventually require surgery. There are no approved pharmacologic therapies for FSCD. We believe ontunisertib has the potential to change the paradigm for treating FSCD patients and provide the first pharmacologic treatment for strictures. Ontunisertib is designed to act locally in the gastrointestinal tract, enabling high exposure in the target tissue. Then, following absorption, ontunisertib is rapidly inactivated in the liver to avoid potential toxicities associated with systemic TGFβ signaling inhibition. In November 2025, we announced topline results of the global randomized, double-blind, placebo-controlled Phase 2a trial of ontunisertib, or the STENOVA trial, in 103 FSCD symptomatic patients with at least one ileal stricture. Part A of the STENOVA study achieved its primary endpoint of assessing the safety and tolerability of ontunisertib 100mg QD and 200mg BID in FSCD patients. The severity and incidence of adverse events were balanced across all treatment arms, including the placebo. Pharmacokinetic results confirmed the GI-restricted profile of ontunisertib with high local and low systemic exposure of ontunisertib in FSCD patients. We also observed positive signals on several exploratory clinical endpoints. The 48-week open-label treatment extension of the STENOVA trial with ontunisertib is currently ongoing and we expect to report the results of such open-label treatment extension in the second half of 2026. Based on the results observed in the STENOVA study to date and our positive interactions with the U.S. Food and Drug Administration, or the FDA, we are preparing to initiate a Phase 2b trial of ontunisertib in patients with symptomatic FSCD in the second half of 2026.

More on AGMB.

Figures from AgomAb Therapeutics NV's filings with the U.S. SEC, standardised automatically; prices are end-of-day closes. Not financial advice.