other material
confidence high
sentiment negative
materiality 0.85
Kezar halts lupus trial after 4 deaths; IDMC recommends stop
Kezar Life Sciences, Inc.
- Voluntary cessation of enrollment and dosing in PALIZADE Phase 2b trial of zetomipzomib in lupus nephritis.
- IDMC recommendation after review of 4 Grade 5 (fatal) serious adverse events in Philippines and Argentina.
- Three fatalities showed common symptom pattern and proximity to dosing; additional non-fatal SAEs with similar pattern.
- Kezar remains blinded to treatment arms; no prior deaths or serious opportunistic infections in earlier trials.
- PORTOLA trial in autoimmune hepatitis continues enrollment; no Grade 4 or 5 SAEs observed there to date.