USFDAMay 7, 2026, 07:32 AM
Vera Therapeutics atacicept BLA gets FDA Priority Review; PDUFA July 7
AI Summary
Vera Therapeutics announced its Q1 2026 financial results and significant business updates. The U.S. FDA granted priority review to its Biologics License Application (BLA) for atacicept in IgA Nephropathy (IgAN), setting a PDUFA date of July 7, 2026. The company is on track for a U.S. commercial launch of atacicept in mid-2026, pending regulatory approval, and expects its strong balance sheet to fund operations beyond the launch. The company reported an increased net loss for the quarter.
Key Highlights
- FDA granted Priority Review for atacicept BLA in IgAN; PDUFA date July 7, 2026.
- On track for U.S. commercial launch of atacicept in mid-2026, pending approval.
- Q1 2026 net loss was $121.0 million, compared to $51.7 million in Q1 2025.
- Net loss per diluted share was $1.69 in Q1 2026, versus $0.81 in Q1 2025.
- Cash, cash equivalents, and marketable securities totaled $596.8 million as of March 31, 2026.
- Initial results from PIONEER Phase 2 trial for atacicept expected in Q2 2026.