Zenas BioPharma Touts Phase 3 Win, But Stock Crashes

Zenas BioPharma Inc. (NASDAQ:ZBIO) banal is trading little connected Monday aft the institution released results from the Phase 3 INDIGO proceedings of obexelimab successful Immunoglobulin G4-Related Disease (IgG4-RD).

IgG4-RD is an immune strategy upset wherever the assemblage creates excess IgG4 antibodies, starring to inflammation and dense, tumor-like insubstantial growths (fibrosis) successful aggregate organs.

Obexelimab met the superior endpoint, demonstrating a highly statistically important and clinically meaningful 56% simplification successful the hazard of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period.

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Obexelimab besides met and demonstrated highly statistically important enactment compared to placebo connected each 4 cardinal secondary endpoints, which were simplification successful investigator-assessed IgG4-RD flare, the fig of flares requiring rescue therapy, the proportionality of patients achieving implicit remission, and the cumulative usage of IgG4-RD rescue therapy.

Rates of infections, including Grade 3, were little successful the obexelimab limb compared to placebo, and the incidence of injection tract reactions was akin crossed some survey arms.

The institution expects that afloat information from the INDIGO proceedings volition beryllium presented astatine a aboriginal aesculapian meeting.

Despite touting encouraging information from the pivotal trial, Zenas BioPharma banal is trading lower.

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In April 2025, the U.S. Food and Drug Administration (FDA) approved Amgen Inc.'s (NASDAQ:AMGN) Uplizna (inebilizumab-cdon) arsenic the archetypal and lone attraction for big patients with IgG4-RD.

The support was supported by information from the MITIGATE proceedings that showed an 87% simplification successful the hazard of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period.

10.3% of participants receiving Uplizna experienced a flare compared to 59.7% of participants receiving a placebo.

Amgen added Uplizna via a $27.8 cardinal acquisition of Horizon Therapeutics.

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Zenas anticipates submitting the obexelimab Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for IgG4-RD successful the 2nd 4th of 2026.