Efficacy — refractory population held up well
Induction non-responders (the hardest cohort) on continued 50 mg at Week 44: clinical remission 37.2%, clinical response 61.5%, endoscopic improvement 48.0%, HEMI 44.6%, endoscopic remission 34.5% — clean dose-response vs 25 mg across every endpoint.
Part 1 relapsers recaptured: placebo→50 mg gave 45.0% remission / 69.7% response; 25 mg→50 mg escalation gave 45.5% / 66.7%. This is the practical takeaway — dose escalation rescues relapsers, supporting a flexible label.
Safety — the actual point of Part 2
Part 2 existed to fatten the safety database (1,704 patient-years integrated), since the malignancy/NMSC signal was the post-Part 1 overhang. Results:
| Malignancy ex-NMSC (All Active) | EAIR/100 PY | UC background |
| Integrated UC program | 0.35 | 0.30–0.70 |
| Ph3 Maint (P1+P2) | 0.56 | 0.30–0.70 |
| Part 2 only | 0.48 | 0.30–0.70 |
NMSC all-active sits at 0.59 (integrated) / 1.26 (P1+P2) / 0.95 (Part 2), against a 0.70–1.40 background. Note the 25 mg Part 2 NMSC point estimate is 1.52 — above range — but that's two events on small PYs, and all four Part 2 NMSCs had established risk factors (age, thiopurines, prior skin cancer). Two non-NMSC malignancies, both 50 mg, both deemed unrelated.
Bottom line: No new safety pattern, everything ex-25mg-NMSC within background, NDA reaffirmed for Q4 2026. The wide CIs on small event counts remain the bear's handhold, but management got what they needed here — the readout de-risks rather than re-rates the safety question ahead of filing.
Webcast at 10:30pm CEST tonight; detailed exposure-adjusted breakdowns by dose/PY/patient characteristics come there. Next catalysts: H1 results Sept 21, NDA Q4, ENHANCE-CD Crohn's mid-2027.
Want me to fold this into a Fiche Biotech update or draft the La Lettre item?