Zenas BioPharma (NASDAQ:ZBIO) announced its full-year 2025 financial results on March 16, 2026, marking a pivotal year that has positioned the Waltham, Massachusetts-based biotech for its first potential product launch.
The company’s lead candidate, obexelimab, achieved its primary endpoint in the Phase 3 INDIGO registrational trial for Immunoglobulin G4-related disease (IgG4-RD).
The data revealed a statistically significant 56% reduction in the risk of disease flares compared to placebo, with a compelling safety profile that showed no new signals over the 52-week study period.
Armed with these results, Zenas is moving aggressively toward regulatory filings.
The company confirmed it remains on track to submit a Biologics License Application (BLA) to the FDA in the second quarter of 2026, followed by a Marketing Authorization Application (MAA) to the EMA in the second half of the year.
Obexelimab's unique mechanism—which inhibits B cells via CD19 and FcγRIIb without depleting them—along with its at-home subcutaneous administration, is expected to differentiate it as a first-in-class option for the roughly 20,000 to 40,000 patients in the U.S. currently lacking approved therapies.