Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Obexelimab (CD19xFcyRIIb) in IgG4-related disease. The expected timing is based on the latest available company guidance and may change.
INDIGO trial. 11/12/24- Completed enrollment. 8/12/25- Topline data by YE 2025 and submit BLA in 2026. 11/12/25:- INDIGO Ph3 topline obexelimab IgG4-RD data expected around YE 2025. 01/05/26:- INDIGO Ph3 IgG4-RD trial met primary and key secondary endpoints; BLA planned Q2 2026, EMA MAA H2 2026. 03/16/26:- Reaffirmed INDIGO IgG4-RD BLA filing Q2 2026 and EMA MAA H2 2026; full data at future meeting. 05/13/26:- INDIGO Ph3 IgG4-RD results to be presented orally at EULAR 2026; BLA submission remains planned Q2 2026. 05/19/26:- INDIGO Ph3 IgG4-RD efficacy and safety to be presented at EULAR June 4, 2026. 05/28/26:- BLA submitted to FDA for IgG4-RD; INDIGO data presented at EULAR June 4, 2026. 06/02/26:- Additional INDIGO Ph3 IgG4-RD data published; BLA submitted May 2026; OLE continues. 08/13/26:- FDA accepted the INDIGO Ph3 IgG4-RD BLA. PDUFA action is expected May 27, 2027; EMA MAA is expected H2 2026.
Verification
Confirm timing and program details against the company announcement or filing.