(RTTNews) - Zenas BioPharma, Inc. (ZBIO) announced that it will present full results from the Phase 3 INDIGO registrational trial of Obexelimab (CD19 monoclonal antibody) in Immunoglobulin G4-Related Disease at the upcoming EULAR 2026 Congress on June 4,2026.
The data will provide additional details ahead of the company's planned Biologics License Application (BLA) submission in Q2 2026.
The INDIGO trial is a global, randomized, double-blind, placebo-controlled study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized period.
Obexelimab also showed significant benefit across all four key secondary endpoints, including time to first flare requiring rescue therapy, number of flares requiring rescue therapy, proportion of patients achieving complete remission, and cumulative glucocorticoid rescue therapy use. The therapy was well tolerated, with fewer Grade =3 adverse events and serious adverse events compared to placebo, and no new safety signals observed.
Immunoglobulin G4-related disease (IgG4-RD), is a chronic, immune-mediated condition that can affect multiple organs, often leading to serious complications if untreated. Obexelimab, designed to selectively deplete B cells, has shown promising efficacy and safety in this rare disease setting.
Wedbush analyst Martin Fan reaffirmed an Outperform rating on ZBIO with a 12-month price target of $45.00. Shares of ZBIO closed Monday's trade at $16.91, down 7.80%. Fan noted that INDIGO's statistically significant efficacy benefit and favorable safety profile versus Uplizna (Amgen) support expectations for approval. He projects Obexelimab could achieve near-term sales of ~$7 million in 2027, rising to ~$450 million by 2030, with upside potential given a larger addressable market than current estimates.
Zenas ended Q1 2026 with $718.5 million in cash, equivalents, and investments, providing runway through Q2 2029. The company is also expecting $45 million from an underwriters' over-allotment option and $150 million contingent upon FDA approval of Obexelimab.
ZBIO has traded between $8.91 and $44.60 over the past year. The stock is currently trading in the pre-market at $18.07, up 7.83%.
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