Zenas BioPharma Announces Positive Phase 3 Obexelimab Results

Zenas BioPharma, Inc. ( (ZBIO) ) has shared an update.

On January 5, 2026, Zenas BioPharma reported positive top-line data from its global, registration-directed Phase 3 INDIGO trial of obexelimab in immunoglobulin G4-related disease (IgG4-RD), in which 194 patients were randomized 1:1 to obexelimab or placebo over 52 weeks. Obexelimab achieved the primary endpoint with a 56% reduction in the risk of IgG4-RD flare requiring rescue therapy versus placebo and showed highly statistically significant benefit across all four key secondary endpoints, while demonstrating a favorable safety profile with lower rates of serious adverse events and infections than placebo and no new safety signals. Building on these results and prior positive Phase 2 MoonStone data in relapsing multiple sclerosis, Zenas plans to submit a Biologics License Application to the U.S. FDA in the second quarter of 2026 and a Marketing Authorization Application to the EMA in the second half of 2026 for obexelimab in IgG4-RD, positioning the drug as a potential first-line, self-administered B cell–inhibiting therapy in a disease with significant unmet need and reinforcing its status as a potential franchise asset underpinning Zenas’ broader autoimmune pipeline and partnership with Bristol Myers Squibb in key Asia-Pacific markets.

The most recent analyst rating on (ZBIO) stock is a Buy with a $55.00 price target. To see the full list of analyst forecasts on Zenas BioPharma, Inc. stock, see the ZBIO Stock Forecast page.

Spark’s Take on ZBIO Stock

According to Spark, TipRanks’ AI Analyst, ZBIO is a Neutral.

Zenas BioPharma’s overall stock score is primarily influenced by its strong technical momentum and positive corporate events, which are offset by poor financial performance and valuation concerns. The company’s recent strategic moves in the autoimmune market provide a promising outlook, but significant financial challenges remain.

To see Spark’s full report on ZBIO stock, click here.

More about Zenas BioPharma, Inc.

Zenas BioPharma, Inc. is a Nasdaq-listed, clinical-stage global biopharmaceutical company focused on developing and commercializing transformative therapies for patients with autoimmune diseases, with a portfolio led by the antibody obexelimab and including multiple sclerosis candidate orelabrutinib and early-stage oral inhibitors ZB021 and ZB022 targeting rheumatic, dermatologic and neurologic indications.

Average Trading Volume: 444,250

Technical Sentiment Signal: Strong Buy

Current Market Cap: $1.85B

For a thorough assessment of ZBIO stock, go to TipRanks’ Stock Analysis page.