Agomab Therapeutics NV filings document the company's foreign private issuer reports, ADS public offering disclosures, governance materials, and clinical-stage biopharmaceutical updates. Form 6-K reports have included the closing of the company's initial public offering of American Depositary Shares, amended and restated articles of association, press releases, annual meeting materials, proxy forms, and voting documentation.
AGMB's regulatory record also discloses capital-structure matters tied to ADSs and common shares, incorporation of materials into a Form S-8 registration statement, financial results, business updates, shareholder voting matters, and clinical or regulatory disclosures related to its fibro-inflammatory disease programs.
AgomAb Therapeutics NV (AGMB) reported topline results from the 48-week open-label extension (OLE) of its Phase 2a STENOVA study of ontunisertib in fibrostenosing Crohn’s disease. 49 participants entered the OLE, representing 94% of eligible Part A participants, and 37 completed it. Participants received ontunisertib 200 mg twice daily for up to 48 additional weeks, with treatment reported for up to 60 weeks overall.
The company reported one FSCD-related endoscopic balloon dilation, a 3% annualized event rate, and no surgeries. At Week 48, 97% of evaluable patients were in clinical remission by CDAI. Five serious adverse events occurred in four patients and were considered unrelated or unlikely related to treatment. Imaging assessments suggested stabilization of fibrotic strictures; the company said optional Week 48 endoscopy data were too limited for reliable interpretation. AgomAb plans to initiate the global NOV-ERA Phase 2b study in the coming months, testing three doses or placebo. Ontunisertib is investigational and not approved; its efficacy and safety have not been established.
Agomab Therapeutics NV (AGMB) reported that director Garcia Marino received a grant of 57,482 stock options on September 11, 2026. The options have an exercise price of $13.94 per common share, expire on January 15, 2036, and relate to common shares that may be represented by American Depositary Shares.
According to the vesting terms, 33% of the shares underlying this option vest on September 11, 2027, with the remaining options vesting in 24 equal monthly installments thereafter, subject to continued service. No Rule 10b5-1 trading plan is reported for this award.
AgomAb Therapeutics NV (AGMB) reported that director Naimish Patel received a grant of stock options on September 11, 2026. The award covers 56,328 options to purchase common shares at an exercise price of $13.94 per share, expiring on January 15, 2036.
Each option relates to one common share, which may be represented by an American Depositary Share. According to the vesting schedule, 33% of the shares underlying this option vest on September 11, 2027, with the remaining shares vesting in 24 equal monthly installments thereafter, subject to Mr. Patel’s continued service. The exercise price is shown in U.S. dollars based on a $1.1616 per EUR 1.00 exchange rate as of September 10, 2026, and no Rule 10b5-1 trading plan is reported for this grant.
Agomab Therapeutics NV (AGMB) has a new Form 3 on file for director Garcia Marino, serving as an initial statement of beneficial ownership of securities. The filing reports no transactions and no reportable equity holdings by the director at this time and includes a Power of Attorney as an exhibit.
Agomab Therapeutics NV (AGMB) filed an initial ownership report for Naimish Patel, who is identified as a director of the company. The Form 3 does not report any equity holdings or transactions by the director, and the only additional item referenced is an Exhibit 24 Power of Attorney.
Agomab Therapeutics NV (AGMB) reported positive Phase 1 results for its inhaled ALK5 inhibitor AGMB-447 in patients with idiopathic pulmonary fibrosis (IPF) and described the design of the Phase 2 INSPIRIA study. In 10 IPF patients, AGMB-447 showed a generally favorable safety and tolerability profile at 4.5 mg twice daily, with low systemic and high lung exposure and no systemic safety signals detected. Target engagement was demonstrated by >50% reduction of pSMAD3 in bronchoalveolar lavage cells. Agomab has submitted a Clinical Trial Application for INSPIRIA, a 24-week randomized, double-blind, placebo-controlled Phase 2 trial in approximately 120 IPF patients, with change in forced vital capacity at Week 24 as the primary endpoint and trial initiation anticipated in the second half of 2026.
Agomab Therapeutics NV (AGMB) reports that shareholders approved all resolutions at its Special and Extraordinary General Shareholders' Meeting held on September 11, 2026. Key items included appointing Marino Garcia and Naimish Patel, M.D. as non-executive directors and approving a consolidation and split adjustment of outstanding pre-IPO warrants to align them with the share split implemented in connection with Agomab's IPO in February 2026.
Agomab describes itself as a clinical-stage biopharmaceutical company developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need.
Agomab Therapeutics NV is calling a special and extraordinary general shareholders’ meeting on September 11, 2026 at 2:30pm CEST in Antwerp. The board proposes appointing Marino Garcia and Dr. Naimish Patel as non-executive directors for four-year terms ending after the 2030 annual meeting, subject to shareholder approval.
The notice sets out Belgian-law procedures for participation, including a Record Date of September 4, 2026, advance notification or proxy/voting form submission by September 9, 2026, and clarifies that holders of subscription rights and ADS holders may attend or act through specific channels with defined rights.
Agomab Therapeutics, a clinical-stage biopharmaceutical company focused on fibro-inflammatory diseases, reported half year 2026 results for the period ended June 30, 2026. The company recorded a net loss of €30,971 thousand on total operating expenses of €35,138 thousand, including research and development expenses of €22,967 thousand and general and administrative expenses of €12,171 thousand.
Agomab strengthened its balance sheet through a Nasdaq initial public offering, raising $208 million in gross proceeds. Cash and cash investments totaled €252 million at June 30, 2026, including €221,588 thousand of cash and cash equivalents, which management expects to support the cash runway into the first half of 2029.
Clinically, Agomab reported regulatory alignment with the U.S. FDA on key elements of the NOV-ERA Phase 2b study of ontunisertib in Fibrostenosing Crohn’s Disease, and plans to initiate this trial and a Phase 2 study of AGMB-447 in idiopathic pulmonary fibrosis in the second half of 2026. Topline data from the OLE part of the STENOVA study with ontunisertib and from the Phase 1b IPF cohort with AGMB-447 are expected in the coming months.
Agomab Therapeutics outlined the design of its NOV-ERA Phase 2b trial of ontunisertib for fibrostenosing Crohn’s disease (FSCD), a form of Crohn’s that affects an estimated 46% of patients and currently has no approved drug treatments. The company has aligned with the FDA on a novel primary endpoint: endoscopic passability of the ileal index stricture at Week 24, assessed by the SES-CD narrowing score.
The randomized, double-blind, placebo-controlled study will enroll up to 320 adults worldwide. Participants will receive ontunisertib 400 mg, 200 mg, 100 mg, or placebo twice daily over a 52-week treatment period, after a 6-week screening and before a 2-week follow-up. Agomab plans to dose the first participants in the second half of 2026, following remaining regulatory and ethics approvals. Ontunisertib is an oral, GI-restricted ALK5/TGF-β RI inhibitor with FDA Fast Track designation.