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Zenas BioPharma
Zenas BioPharma (ZBIO) investor relations material
Zenas BioPharma Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Result summary5 Jan, 2026
INDIGO Phase III Trial Design and Objectives
The INDIGO Phase III trial was a multicenter, randomized, double-blind, placebo-controlled study evaluating obexelimab in IgG4-RD, enrolling 194 patients globally with balanced baseline characteristics.
The primary endpoint was time to first disease flare through week 52; key secondary endpoints included flare rate, remission, and rescue medication use.
Weekly subcutaneous dosing was used, and all participants could enter an open-label extension.
Efficacy Results
Obexelimab reduced the risk of IgG4-RD flare by 56% versus placebo (HR=0.443, p=0.0005), with 27% of obexelimab patients experiencing flares versus 55% on placebo.
All four key secondary endpoints were met, including time to flare, flare rate, complete remission, and reduced glucocorticoid rescue therapy use.
Over 70% of patients on obexelimab were protected from flares at 52 weeks.
Safety, Tolerability, and Subgroup Insights
Obexelimab showed a favorable safety profile, with lower rates of serious adverse events (10% vs. 19%) and infections compared to placebo; injection site reactions were similar between groups.
No new safety signals or increased risk of malignancy were observed.
No correlation was found between B-cell count and infection rates.
Flare events in the obexelimab arm leveled off after steroid taper, with separation from placebo seen post-taper.
Detail obexelimab's B-cell inhibition advantage
Explain the IgG4-RD commercial opportunity
What is the strategy for obexelimab beyond IgG4-RD?
Reconcile HR with KOL first-line enthusiasm
Clarify Royalty Pharma Phase III milestone
How do INDIGO results impact SLE expectations?
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Next Zenas BioPharma earnings date
Q4 202512 Mar, 2026
Zenas BioPharma
Next Zenas BioPharma earnings date
Q4 202512 Mar, 2026
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Frequently asked questions
Zenas BioPharma Inc is a biopharmaceutical company dedicated to the development and commercialization of immunology-based therapies to treat autoimmune and rare diseases. The company focuses on leveraging its expertise in immunology to create innovative treatments that address significant unmet medical needs. Zenas BioPharma’s portfolio includes a range of product candidates designed to modulate immune system responses, aimed at improving the quality of life for patients with challenging and often underserved conditions. The company is headquartered in Waltham, Massachusetts, and its shares are listed on the Nasdaq.
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