Vera reports positive ORIGIN 3 results and plans expanded FDA filing
Vera Therapeutics reported on October 22 that TRUTAKNA met the primary endpoint and all prespecified endpoints in the ORIGIN 3 Phase 3 study for adults with primary IgA nephropathy. Proteinuria fell significantly at 36 weeks, while the final analysis also showed statistically significant results for kidney-function measures and disease-progression risk. Vera plans to submit a supplemental BLA to the FDA in Q4 2026, seeking full approval in 2027.
Why it matters
The filing would seek to convert TRUTAKNA's accelerated approval into full approval for the broader efficacy data package. Vera expects a potential full-approval decision in 2027, while one report specifies mid-2027; the timing remains uncertain.
Key facts
- 1ORIGIN 3 achieved its primary endpoint of statistically significant proteinuria reduction at 36 weeks and was statistically significant across all prespecified endpoints in the final analysis. stocktitan.net
- 2Serious adverse events occurred in 7% of patients receiving TRUTAKNA and 15% of those receiving placebo. rttnews.com
- 3The overall adverse-event rates were 75% with TRUTAKNA and 78% with placebo. rttnews.com
- 4Vera intends to submit a supplemental BLA to the U.S. FDA in Q4 2026 for potential full approval in 2027. stocktitan.net
- 5The trial results were presented at ASN Kidney Week 2026 and published in The New England Journal of Medicine. rttnews.com
Open questions
- Vera's full-approval timing is described as 2027 in materials 1-4, while material 5 specifies mid-2027.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.