Catalyst overview
Research summary
This catalyst tracks a Approved update for Atacicept in IgA nephropathy. The expected timing is based on the latest available company guidance and may change.
ORIGIN, PIONEER studies. 4/3/25- Completed full enrollment. 6/2/25- 36wk data, met primary endpoint. 8/5/25- Initial results from PIONEER study in Q4 2025. 11/6/25- ORIGIN data at ASN'25. 11/7/25– Submitted BLA to FDA via accelerated approval. 02/26/26:- Priority review granted; PDUFA July 7, 2026. PIONEER results 1H 2026, ORIGIN 3 eGFR data 2027. Launch mid-2026. 05/07/26:- Priority review reiterated; PIONEER initial results Q2 2026. ORIGIN 3 eGFR data Q1 2027. Launch mid-2026. 06/02/26:- ORIGIN 3 eGFR results expected Q3 2026; plan sBLA Q4 2026. 07/07/26:- FDA accelerated approval granted for TRUTAKNA in primary IgAN. ORIGIN 3 eGFR results expected Q3 2026. 08/10/26:- FDA approval granted; launch underway. ORIGIN 3 efficacy Q3 2026; sBLA Q4 2026; PIONEER results Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.