Recent Updates — ZBIO

Zenas BioPharma announced new clinical data from its Phase 3 INDIGO trial for obexelimab in immunoglobulin G4-related disease (IgG4-RD). Open-label extension findings demonstrated that the 12-month probability of remaining flare-free was 0.93 based on investigator-confirmed flares and 0.87 based on adjudication committee-confirmed flares. The median cumulative glucocorticoid rescue dose was 0 mg, and obexelimab significantly reduced cumulative glucocorticoid toxicity versus placebo at week 52 (p=0.021). Initial sub-study results showed that vaccination during a treatment-free window resulted in seroimmunity to influenza in 86% of participants and COVID-19 in 100%, with no disease flares observed during the window. Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing therapies for autoimmune diseases.

Zenas BioPharma reported a net loss of $111.5 million for the quarter ended June 30, 2026, compared to a $52.2 million loss in the prior year period. The company holds $673.9 million in cash and investments as of June 30, 2026. Key operational highlights include FDA acceptance of the Biologics License Application for obexelimab for IgG4-RD, establishing a PDUFA target action date of May 27, 2027. The Board appointed Christy J. Oliger as a Class II director effective September 1, 2026, increasing the board size by one. Additionally, CFO Jennifer Fox will transition to Strategic Advisor to the Board Chair on September 30, 2026. Zenas BioPharma is a clinical-stage global biopharmaceutical company advancing therapies for autoimmune and inflammatory diseases.