Agomab Therapeutics NV reports news centered on its clinical-stage fibro-inflammatory disease pipeline, public-company financing, and intellectual-property position. Company updates have covered ontunisertib in fibrostenosing Crohn's disease, AGMB-447 in idiopathic pulmonary fibrosis, U.S. patent protection for AGMB-447, and regulatory interactions related to clinical-study design.
Recurring AGMB news also includes financial results, cash runway commentary, Nasdaq ADS trading status, initial public offering activity, and annual meeting or governance materials for the Belgian foreign private issuer.
Agomab (AGMB) has dosed the first patient in NOV-ERA, its global Phase 2b study of ontunisertib for symptomatic fibrostenosing Crohn's disease.
The randomized, double-blind, placebo-controlled study is expected to enroll approximately 320 adults. Participants will receive 400 mg, 200 mg or 100 mg twice daily, or matching placebo, for 52 weeks. The primary endpoint is endoscopic passability—whether an endoscope can pass through the affected bowel—at Week 24. Agomab said positive Phase 2a STENOVA results support continued development, while long-term safety and tolerability findings from its open-label extension support the 400 mg twice-daily arm.
Study initiation triggers a €7 million milestone payment to former Origo Biopharma shareholders under Agomab's 2021 acquisition. That agreement included up to €20 million in potential development and regulatory milestones; €10 million has become payable to date.
Agomab (AGMB) will present STENOVA extension data on ontunisertib at UEG Week on October 20, 2026, in Barcelona, Spain.
The open-label extension, in which treatment was known to participants, evaluated 200 mg twice daily for up to 60 weeks in patients with symptomatic fibrostenosing Crohn’s disease. It assessed long-term safety and drug exposure and explored event rates and disease progression. Agomab plans to advance the global NOV-ERA Phase 2b study in the coming months.
The company will also host a scientific symposium on fibro-inflammation in inflammatory bowel disease on October 19. Ontunisertib remains investigational; its safety and efficacy have not been established.
Agomab (AGMB) reported topline results from the STENOVA open-label extension evaluating ontunisertib in patients with fibrostenosing Crohn’s disease.
The 48-week extension enrolled 49 patients, or 94% of eligible participants, receiving 200 mg twice daily alongside standard care. Agomab described safety and tolerability as generally favorable through up to 60 weeks of treatment; five serious adverse events in four patients were considered unrelated or unlikely related to treatment. The annualized disease-related event rate was 3%, with one endoscopic balloon dilation and no surgeries. Imaging suggested stricture stabilization, and 97% of evaluable patients were in clinical remission at extension Week 48. Systemic drug exposure remained low. Optional Week 48 endoscopy data were too limited for reliable interpretation. Regulatory filings for NOV-ERA Phase 2b are complete; Agomab plans to initiate the approximately 320-patient trial in the coming months.
Agomab Therapeutics (AGMB) reported positive Phase 1 results for inhaled ALK5 inhibitor AGMB-447 in idiopathic pulmonary fibrosis (IPF) patients and outlined its planned Phase 2 INSPIRIA trial.
In Part C of the Phase 1 study, 10 IPF patients received 4.5–6 mg twice daily for 14 days via nebulization. At 4.5 mg BID, AGMB-447 showed a generally favorable safety and tolerability profile, with no systemic safety signals at any dose. Adverse events were more frequent at 6 mg BID; the most common were cough and bronchospasm, with cough episodes short and mainly limited to inhalation, and no worsening of disease-related cough over 14 days.
PK data in IPF confirmed lung-restricted exposure, with 4.5 mg BID achieving bronchoalveolar lavage levels above IC90 for at least 6 hours and above IC50 for 24 hours. pSMAD3 reduction >50% in BAL cells indicated robust ALK5 target engagement. Agomab has submitted a Clinical Trial Application for INSPIRIA, a 24-week, randomized, double-blind, placebo-controlled Phase 2 study in about 120 IPF patients, randomizing 2:1 to AGMB-447 4 mg BID or placebo on top of standard of care, with change in forced vital capacity at Week 24 as the primary endpoint.
Agomab Therapeutics (AGMB) reports that shareholders approved all resolutions at its Special and Extraordinary General Shareholders' Meeting held on September 11, 2026.
Approvals include the appointments of Marino Garcia and Naimish Patel, M.D. as non-executive members of the Board of Directors and the consolidation and split adjustment of outstanding pre-IPO warrants. The warrant changes align these instruments with the share split implemented in connection with Agomab's IPO in February 2026. Meeting materials, including biographies of the new Board members, are available on the company’s website.
Agomab Therapeutics (AGMB) will participate in several investor conferences in New York in September 2026, featuring fireside chats at multiple events.
The company plans to attend Citi's 2026 Biopharma Back to School Conference on September 10, the 2026 Cantor Global Healthcare Conference on September 11, the H.C. Wainwright 28th Annual Global Investment Conference on September 15, and the Morgan Stanley 24th Annual Global Healthcare Conference on September 16.
Agomab Therapeutics (Nasdaq: AGMB) announced that its Board has proposed appointing Marino Garcia and Naimish Patel, M.D. as non-executive directors, subject to shareholder approval at a Special General Meeting on September 11, 2026 in Antwerp, Belgium. Garcia is President, CEO and director of Dianthus Therapeutics (Nasdaq: DNTH), while Dr. Patel is Chief Medical Officer of CRISPR Therapeutics (Nasdaq: CRSP).
Agomab will also hold an Extraordinary General Shareholders’ Meeting the same day at 2:30 PM CEST to seek approval for a proposed consolidation and split of outstanding pre-IPO warrants, adjusting each warrant to reflect the share split implemented with Agomab’s February 2026 IPO. Meeting materials and detailed biographies are available on Agomab’s investor website.
Agomab (Nasdaq: AGMB) reported unaudited half year 2026 results and confirmed its 2026 outlook, highlighting clinical, regulatory and financing progress. Cash, cash equivalents and short-term investments totaled €252.0 million at June 30, 2026, supported by approximately $208 million in gross IPO proceeds, which Agomab expects will fund operations into the first half of 2029.
According to the company, regulatory alignment with the FDA has been achieved on key elements of the NOV-ERA Phase 2b ontunisertib study in fibrostenosing Crohn’s disease, with first dosing planned in the second half of 2026. A Phase 2 study of AGMB-447 in idiopathic pulmonary fibrosis is also targeted to start in the second half of 2026, with multiple topline datasets from ongoing studies expected in the coming months. For the six months ended June 30, 2026, Agomab reported R&D expenses of €23.0 million, G&A expenses of €12.2 million, and a net loss of €31.0 million, compared to €26.9 million a year earlier.
Agomab (Nasdaq: AGMB) outlined the NOV-ERA Phase 2b trial design evaluating oral ALK5 inhibitor ontunisertib in fibrostenosing Crohn’s disease (FSCD).
The randomized, double-blind, placebo-controlled study will enroll up to 320 adults globally, use endoscopic passability at Week 24 as the primary endpoint, and plans first dosing in 2H 2026 following regulatory and ethics approvals.
Agomab (Nasdaq: AGMB)/b) reported results of its Annual General Meeting held May 26, 2026. Shareholders approved all agenda items, including the statutory financial statements for the year ended December 31, 2025, discharge of directors and auditor, and the reappointments of and Tim Knotnerus.
AGM documents and detailed voting results are available on Agomab’s investor relations website.