other material
confidence high
sentiment neutral
materiality 0.75
Kyverna completes SPS Phase 2 enrollment; BLA filing now 1H 2026; Q1 net loss $44.6M
Kyverna Therapeutics, Inc.
- Enrollment completed in KYSA-8 pivotal Phase 2 trial of KYV-101 in stiff person syndrome; topline data 1H 2026.
- BLA filing for KYV-101 in SPS accelerated to 1H 2026 (from prior 2026 guidance).
- FDA aligns on registrational Phase 3 for myasthenia gravis; interim Phase 2 data expected 2H 2025.
- Cash and equivalents $242.6M; runway into 2027 supports first BLA, Phase 3 MG, and pre-launch activities.
- Workforce reduced ~16% in Q1 2025; Q1 net loss $44.6M ($1.03/shr) vs $26.7M ($1.12/shr) in Q1 2024.