Zenas Biopharma Inc

Zenas Biopharma Inc (ZBIO) News & Events

$31.270

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ZBIO News

ZBIO Events

8/13 08:00

Jennifer Fox to Transition to Strategic Advisor Role

The company announced that Jennifer Fox will transition from her current role as CFO and chief business officer to serve in a new role as strategic advisor to the board chair effective September 30. Joe Farmer, president and COO, will serve as principal financial officer and principal accounting officer until the appointment of a CFO.

8/13 08:00

Zenas Reports Q2 Revenue of $1M, Below Consensus of $15M

Reports Q2 revenue $1M, consensus $15M. "2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027. Our expanding team is actively preparing for the potential commercialization of our first product," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "The strength of the Phase 3 INDIGO data for obexelimab in IgG4-RD was underscored by its selection as an oral presentation at EULAR and simultaneous publication in the New England Journal of Medicine. Beyond IgG4-RD, we are on track to report Phase 2 topline data for obexelimab in SLE and initial Phase 1 data for ZB021 by year-end. We continue to execute across our portfolio and make meaningful progress toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune and chronic inflammatory diseases."

5/28 07:30

Zenas BioPharma Submits BLA for Obexelimab to FDA

Zenas BioPharma announced the submission of its biologics license application, or BLA, to the FDA for obexelimab in Immunoglobulin G4-Related Disease. IgG4-RD is a debilitating chronic fibro-inflammatory disease affecting multiple organ systems, often resulting in irreversible tissue damage and organ failure. Obexelimab, an investigational therapy, is a bifunctional monoclonal antibody designed to bind both CD19 and FcgRIIb to inhibit B cell function. The BLA submission is supported by the results of the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD. In INDIGO, obexelimab met the 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 placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints and was generally well tolerated. Data from the INDIGO trial will be presented during an oral session at the European Alliance of Associations for Rheumatology 2026 Congress in London, UK, on June 4.

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