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ZBIO News
ZBIO Events
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.
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."
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.
Zenas BioPharma Doses First Subject in Phase 1 Trial of ZB021
Zenas BioPharma announced that the first subject has been dosed in the Phase 1 trial of ZB021, a novel potentially best-in-class oral IL-17AA/AF inhibitor. The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetic properties of ZB021 in healthy volunteers and to establish proof-of-concept in patients with plaque psoriasis. Phase 1 SAD and MAD data expected by year-end 2026, with proof-of-concept data in psoriasis patients anticipated in 2027.
Zenas Reports Q1 Revenue of $0, Cash Reserves at $718.5M
Reports Q1 revenue $0 vs. $10M last year. As of March 31 the Company's cash, cash equivalents and investments were $718.5M. "This quarter we continued to execute across our portfolio and made 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," said Lonnie Moulder, Founder and CEO of Zenas. "Over the next three quarters, we expect to achieve important clinical and regulatory milestones, including the presentation of INDIGO study results at EULAR, the filing and acceptance of our marketing applications for obexelimab for IgG4-RD in the U.S. and Europe, topline results from the SunStone trial, and initial clinical data for ZB021, our oral IL-17 AA/AF inhibitor. With our balance sheet strengthened by recent financings, Zenas remains focused on preparing for the potential commercialization of obexelimab while continuing to advance our broader pipeline."
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