Zenas Receives FDA Acceptance of Obexelimab BLA
The clinical-stage biopharmaceutical company posted a $111.5 million net loss as it prepared for a potential May 27, 2027, PDUFA decision on obexelimab for IgG4-related disease.
Zenas BioPharma (ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for autoimmune and inflammatory diseases, said the U.S. Food and Drug Administration accepted its Biologics License Application for obexelimab to treat immunoglobulin G4-related disease, with a PDUFA target action date of May 27, 2027.
The acceptance converted a filing that had been on target for submission in the prior quarter into a review with a set calendar. Founder and Chief Executive Officer Lonnie Moulder said 2026 continues to be a transformative year and that the expanding team is actively preparing for potential commercialization of the company’s first product.
Obexelimab, a bifunctional antibody that binds CD19 and FcγRIIb to inhibit B-cell activity without depleting cells, met the primary endpoint of the Phase 3 INDIGO trial with a 56% reduction in the risk of IgG4-RD flare versus placebo over a 52-week randomized period. A majority of treated patients (73.2%) remained flare-free through Week 52, compared with 45.4% on placebo. The drug also met all four key secondary endpoints, lowered glucocorticoid use, and was well tolerated. Additional INDIGO data were presented at EULAR and published in the *New England Journal of Medicine* in June 2026.
Partner Bristol Myers Squibb, which holds exclusive rights in Japan, South Korea, Taiwan, Singapore, Hong Kong, and Australia, announced in August that it submitted a marketing authorization application to Japan’s Pharmaceuticals and Medical Devices Agency. Zenas expects to file a Marketing Authorization Application with the European Medicines Agency in the second half of 2026. New study data confirmed bioequivalence between obexelimab delivered by prefilled syringe and a single-dose prefilled autoinjector pen; the company intends to add the pen and those data to a supplemental BLA if approved and to the European MAA.
Beyond IgG4-RD, Zenas anticipates topline results from the Phase 2 SunStone trial of obexelimab in systemic lupus erythematosus in the fourth quarter of 2026. Dosing is ongoing in the Phase 1 trial of ZB021, an oral IL-17AA/AF inhibitor, with initial clinical data expected by year-end; upon completion of single- and multiple-ascending-dose studies, the company plans a proof-of-concept trial in psoriasis in North America, with results anticipated in 2027. Orelabrutinib Phase 3 trials in primary progressive and non-active secondary progressive multiple sclerosis remain ongoing, and four orelabrutinib abstracts were accepted for MSToronto 2026.
Revenue was $1.0 million for the quarter ended June 30, 2026, from a ZB005 development milestone with Tenacia, versus no revenue a year earlier. Research and development expenses were $62.9 million, up from $43.0 million, attributed to clinical trial and regulatory costs and higher personnel costs, including stock-based compensation from increased headcount. General and administrative expenses were $15.7 million. Acquired in-process research and development expense of $30.0 million related to an Xencor milestone for completion of the FDA marketing authorization submission and a near-term regulatory milestone under the InnoCare Agreement.
Net loss was $111.5 million, or $1.77 a share, compared with a net loss of $52.2 million, or $1.25 a share, a year earlier. Other income (expense), net, was $3.7 million of expense, versus $3.0 million of income, primarily because of higher interest expense on the royalty obligation, senior secured term loan, and convertible senior notes, partially offset by interest income on larger cash balances.
Cash, cash equivalents, and investments were $673.9 million as of June 30, 2026, including $43.2 million of April 2026 over-allotment proceeds from the March 2026 convertible notes and common-stock offerings. That balance, together with $48.7 million received to date in the third quarter and, assuming a potential $75 million Royalty Pharma milestone and $75 million drawn from the Pharmakon debt facility upon FDA approval of obexelimab for IgG4-RD, will fund operations at least through the second quarter of 2029.
Christy Oliger was appointed to the Board of Directors in August. Chief Financial Officer Jennifer Fox is set to move to Strategic Advisor to the Board Chair effective September 30, with President and COO Joe Farmer serving as Principal Financial Officer and Principal Accounting Officer until a new CFO is appointed.