Overview
- The INDIGO trial met its primary endpoint, showing a statistically significant 56% reduction in IgG4-related disease flare risk versus placebo over a 52-week controlled period.
- All four key secondary endpoints were achieved, including fewer investigator-assessed flares, fewer flares requiring rescue therapy, higher complete remission rates, and lower cumulative rescue medication use.
- Safety findings included lower infection rates in the obexelimab group and similar injection-site reaction rates compared with placebo.
- Zenas said it will submit a Biologics License Application to the FDA in the second quarter of 2026 and a Marketing Authorization Application to the EMA in the second half of 2026.
- Shares fell by more than 55% after the readout, as investors weighed the 56% flare reduction against Amgen’s Uplizna 87% result in a separate study, a cross-trial comparison that is not definitive.