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atacicept

Vera Therapeutics · $VERA

Priority Review Breakthrough Therapy BLA

PDUFA Date

July 7, 2026

Time Remaining

105 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

IgA nephropathy (IgAN)

Key Notes

BLA submitted via Accelerated Approval Program. FDA granted Priority Review January 2026. PDUFA July 7, 2026. ORIGIN Phase 3 data: 46% reduction in proteinuria from baseline; 42% reduction vs placebo (p<0.0001) at week 36. Would be first B-cell modulator targeting both BAFF and APRIL for IgAN. Sub-$7B cap.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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