Kyverna Raises $279M Cash to Fund 2026 SPS BLA Filing and Phase 3 gMG Trial
Kyverna ended 2025 with $279 million in cash and equivalents, funding operations through 2028 and supporting its anticipated first-half 2026 SPS BLA filing. Positive miv-cel data include 83% improvement in disability scores in progressive MS trials and ongoing enrollment at 14 sites in the Phase 3 gMG study.
1. Financial Position
Kyverna ended 2025 with $279 million in cash and equivalents, bolstered by $147.5 million in follow-on financing and ATM sales. This liquidity supports operations, the SPS BLA filing and planned commercial launch through 2028 within current manufacturing capacity.
2. SPS Trial and BLA Submission
The Phase 2 KYSA-8 trial in stiff person syndrome demonstrated statistically significant benefit across all primary and secondary endpoints with no high-grade CRS or ICANS observed. Kyverna plans to submit the BLA in the first half of 2026 and is advancing launch-readiness through site activations and key leadership hires.
3. gMG Phase 3 Enrollment
Positive interim Phase 2 data for generalized myasthenia gravis showed durable, drug-free remission and a strong safety profile after a single miv-cel dose. The FDA-aligned Phase 3 KYSA-6 trial has enrolled its first patient and is active at 14 sites across three regions, with additional data due at the April AAN meeting.
4. Progressive MS Data
Investigator-initiated Phase 1 trials in progressive multiple sclerosis treated eight patients at 33M or 100M CAR T doses, achieving 83% improvement in EDSS scores and 100% of evaluable patients showing fatigue score gains. Miv-cel was well-tolerated with no high-grade CRS or ICANS, and all patients remained off other immunomodulatory therapies.