Agomab Therapeutics NV shares fell 17.75% to $9.13 after the company reported results from the 48-week open-label extension of its Phase 2a STENOVA trial of ontunisertib in fibrostenosing Crohn’s disease. Among eligible participants from the initial 12-week placebo-controlled study, 94% enrolled in the extension and received 200 mg twice daily alongside standard care. Through as many as 60 weeks of treatment, one patient required an endoscopic balloon dilation and none progressed to surgery, corresponding to a 3% annualized disease-related event rate. Comparable published data for similar patients receiving advanced therapies show annualized event rates of 23% to 35%, although the comparison was not head-to-head. Four patients reported five serious adverse events, all considered unrelated or unlikely related to treatment. The study found no signs of liver toxicity, cardiac injury, thrombotic events, vasculitis or pro-inflammatory effects, while drug exposure remained gut-restricted and plasma levels stayed below IC50 thresholds. Magnetic resonance enterography indicated stabilization of fibrotic strictures, including among patients who switched from placebo, and 97% of evaluable patients were in clinical remission at Week 48 based on Crohn’s Disease Activity Index scores. Agomab has completed regulatory filings for NOV-ERA, a global Phase 2b study expected to evaluate approximately 320 patients receiving 400 mg, 200 mg or 100 mg of ontunisertib twice daily against placebo.