USFDAAug 10, 2026, 04:13 PM
Vera Therapeutics TRUTAKNA FDA Approval, Q2 Net Loss $109.5M
AI Summary
Vera Therapeutics announced the accelerated FDA approval and commercial launch of TRUTAKNA (atacicept-vymj) for adult patients with primary IgA nephropathy (IgAN) at risk for disease progression. This marks a significant milestone as TRUTAKNA is the first and only therapy to inhibit both BAFF and APRIL for IgAN. The company also reported a net loss of $109.5 million for the second quarter ended June 30, 2026, and provided updates on its clinical programs and upcoming milestones, including an earlier ORIGIN 3 final efficacy analysis and anticipated sBLA submission.
Key Highlights
- TRUTAKNA received accelerated FDA approval for primary IgA nephropathy (IgAN).
- U.S. commercial launch of TRUTAKNA, the first BAFF and APRIL inhibitor for IgAN, is underway.
- Q2 2026 net loss was $109.5 million, or $1.52 per share.
- Cash, cash equivalents, and marketable securities totaled $499.2 million as of June 30, 2026.
- Aligned with FDA for earlier ORIGIN 3 final efficacy analysis, with results expected in Q3 2026.
- Anticipated supplemental Biologics License Application (sBLA) submission to the FDA in Q4 2026.
- Nancy Boman, M.D., Ph.D. appointed Chief Regulatory Officer.
Price Impact
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