USFDAAug 13, 2026, 07:10 AM
Zenas BioPharma's Obexelimab BLA Accepted by FDA; PDUFA May 27, 2027
AI Summary
Zenas BioPharma announced that the FDA accepted its Biologics License Application (BLA) for obexelimab for the treatment of IgG4-RD, setting a PDUFA target action date of May 27, 2027. The company also appointed Christy J. Oliger to its Board of Directors, effective September 1, 2026, bringing over 30 years of biopharmaceutical commercial experience. For Q2 2026, Zenas reported a net loss of $111.5 million, an increase from $52.2 million in Q2 2025, with R&D expenses rising to $62.9 million. The company held $673.9 million in cash, cash equivalents, and investments as of June 30, 2026, and its CFO will transition to a strategic advisor role.
Key Highlights
- Obexelimab BLA for IgG4-RD accepted by FDA with a PDUFA target action date of May 27, 2027.
- Christy J. Oliger appointed to the Board of Directors as a Class II director, effective September 1, 2026.
- Ms. Oliger will receive an initial award of 37,000 stock options and cash compensation for her board service.
- Net loss for Q2 2026 was $111.5 million, compared to $52.2 million for Q2 2025.
- Research and development expenses increased to $62.9 million in Q2 2026 from $43.0 million in Q2 2025.
- Cash, cash equivalents, and investments totaled $673.9 million as of June 30, 2026.
- Revenue for Q2 2026 was $1.0 million, up from $0 in Q2 2025.
- CFO Jennifer Fox will transition to Strategic Advisor to the Board Chair effective September 30, 2026.
Price Impact
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