Kyverna Initiates Rolling SPS BLA Submission; Phase 2 Shows 100% Immunotherapy-Free at 16 Weeks
KYTX•Kyverna launched rolling BLA submission for its miv-cel CAR T therapy in stiff person syndrome, with FDA alignment on trial design and Q4 2026 completion under RMAT. Phase 2 results showed durable 16-week Timed 25-Foot Walk improvement with 100% of patients immunotherapy-free; Phase 3 gMG enrollment advances following one-year follow-up.
1. FDA Aligns on Rolling SPS BLA Submission
Kyverna secured a positive pre-BLA meeting with the FDA, confirming that its single-arm KYSA-8 Phase 2 trial in stiff person syndrome meets all core BLA requirements. The company initiated its rolling submission under RMAT designation and expects to complete the package by Q4 2026.
2. Phase 2 SPS Trial Demonstrates Durable Efficacy
The primary analysis of KYSA-8 showed statistically significant gains in Timed 25-Foot Walk at 16 weeks, with 100% of participants remaining off chronic immunotherapies. A natural history study and planned one-year follow-up further reinforce the durable effect of miv-cel.
3. gMG Program Advances with Phase 3 Enrollment
Enrollment is underway in the registrational Phase 3 trial of miv-cel for generalized myasthenia gravis at 15 active sites worldwide. Earlier Phase 2 data demonstrated deep, sustained reductions in MG-ADL and QMG scores through one year after a single dose.
4. Leadership Appointment and Launch Preparations
To support a planned 2027 launch of miv-cel, Kyverna appointed Nadia Dac as Chief Commercial Officer and is building its commercial infrastructure. These steps aim to position miv-cel as the first approved CAR T therapy for autoimmune diseases.
