Zenas BioPharma reports Q2 2026 results, obexelimab BLA now accepted by FDA

Zenas BioPharma said on August 13, 2026 that the FDA had accepted its Biologics License Application for obexelimab in IgG4-Related Disease. The agency's acceptance in August came with a Prescription Drug User Fee Act target action date of May 27, 2027.¹ The company also said it plans to file a Marketing Authorization Application with the European Medicines Agency in the second half of 2026.¹

The filing rests on the Phase 3 INDIGO trial. Obexelimab hit its primary endpoint, showing a statistically significant 56% reduction in the risk of IgG4-RD flare versus placebo over the 52-week randomized placebo-controlled period, with a hazard ratio of 0.44.¹ Some 73.2% of obexelimab patients stayed flare-free through week 52, compared with 45.4% on placebo.¹ Safety findings showed similar treatment-emergent adverse events between arms, with lower rates of severe events and infections on obexelimab.¹

In Japan, partner Bristol Myers Squibb filed a marketing authorization application with Japan's PMDA in August, based on the INDIGO data, under BMS's exclusive rights covering Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia.¹

Elsewhere in the pipeline, the Phase 2 SunStone trial in lupus is expected to report topline results in the fourth quarter of 2026,¹ and dosing continues in the Phase 1 study of ZB021, with initial data expected by year-end.¹

Financially, cash, cash equivalents and investments stood at $673.9 million as of June 30, 2026.¹ Net loss for the quarter was $111.5 million, versus $52.2 million a year earlier.¹ R&D spending rose to $62.9 million from $43.0 million.¹ The company also disclosed a leadership change: CFO and Chief Business Officer Jennifer Fox will move to a new role as Strategic Advisor to the Board Chair effective September 30.¹