ZBIO Tanks Despite Positive Data From Rare Autoimmune Diseases Study

Zenas BioPharma ZBIO announced that the phase III INDIGO study, which evaluated its lead pipeline candidate, obexelimab, for treating patients with immunoglobulin G4-related disease (IgG4-RD), has met the primary endpoint.

More on ZBIO’s INDIGO Study Data

Data from the same showed that treatment with obexelimab led to 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 — the primary endpoint of the INDIGO study.

Treatment with obexelimab also demonstrated highly statistically significant activity versus placebo across the four key secondary efficacy endpoints of the INDIGO study. These were reductions in investigator-assessed IgG4-RD flare, the number of flares requiring rescue therapy, the proportion of patients achieving complete remission and the cumulative use of IgG4-RD rescue therapy.

Treatment with obexelimab was generally well tolerated, while no new safety concerns were reported.

Despite the positive news, shares of Zenas BioPharma plunged 51.9% on Jan. 5 as the efficacy data might have fallen short of investors' expectations.

Per the company, given its strong clinical activity and favorable safety profile as seen in the INDIGO study, obexelimab could become a first-line, long-term treatment for IgG4-RD.

Zenas BioPharma plans to submit a biologics license application to the FDA seeking approval for obexelimab for the treatment of IgG4-RD in the second quarter of 2026. The company also plans to submit a marketing authorization application to the European Medicines Agency seeking approval for obexelimab for a similar indication in the second half of 2026.

ZBIO's Price Performance

In the past six months, shares of Zenas BioPharma have surged 69.7% compared with the industry’s rise of 21.5%.

ZBIO's Ongoing Development Activities With Obexelimab

Besides IgG4-RD, which is a rare immune-mediated inflammatory condition, Zenas BioPharma is also developing obexelimab for treating other autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective central nervous system (CNS)-penetrant, oral small-molecule BTK inhibitor.

The phase II SunStone study is evaluating obexelimab for the treatment of systemic lupus erythematosus, a chronic autoimmune disease. Top-line data from this study is expected in the fourth quarter of 2026.

A global phase III study is evaluating obexelimab for the treatment of patients with primary progressive multiple sclerosis. Another phase III study evaluating orelabrutinib in patients with non-active secondary progressive multiple sclerosis is expected to be initiated later in the first quarter of 2026.

In the absence of a marketed product, the successful development of obexelimab, along with other pipeline candidates, remains a key focus area for Zenas BioPharma.

Zenas BioPharma, Inc. Price

Zenas BioPharma, Inc. price | Zenas BioPharma, Inc. Quote

ZBIO's Zacks Rank & Stocks to Consider

Zenas BioPharma currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are CorMedix CRMD, Exact Sciences EXAS and ANI Pharmaceuticals ANIP, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CorMedix’s 2026 earnings per share (EPS) have moved up from $2.49 to $2.88. CRMD stock has increased 6.8% in the past six months.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

In the past 60 days, estimates for Exact Sciences’ 2026 EPS have moved up from $1.33 to $1.40. EXAS stock has surged 93.7% in the past six months.

Exact Sciences’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 352.28%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have moved up from $7.81 to $8.08. ANIP stock has rallied 21.2% in the past six months.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.

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This article originally published on Zacks Investment Research (zacks.com).

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