Kyverna Therapeutics, a clinical-stage biopharmaceutical company, provided a corporate update outlining its strategic priorities for 2026.
The company solidified its leadership position in autoimmune CAR T therapies with positive clinical trial results for stiff person syndrome (SPS) and myasthenia gravis in 2025.
Kyverna initiated a Phase 3 registrational trial in generalized myasthenia gravis (gMG) in December 2025, enrolled the first patient, and strengthened its financial position with a follow-on offering in the same month.
BLA Submission for SPS
Kyverna plans to submit its Biologics License Application (BLA) for miv-cel in SPS to the FDA anticipated in 1H 2026.
Executive Leadership Update
Christi Shaw appointed as Executive Chairperson of Kyverna's Board, bringing valuable CAR T commercialization experience to the company.
Financial Position
Kyverna raised approximately $105 million in gross proceeds from a follow-on offering, extending its cash runway into 2028 with around $279 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
Phase 3 gMG Trial
The company continues to advance enrollment for the Phase 3 portion of the KYSA-6 clinical trial in gMG, building on positive interim Phase 2 data and expecting updated Phase 2 data in 2026.
Pipeline Expansion
Kyverna aims to evaluate additional pipeline opportunities in a capital-efficient manner in 2026.
- Kyverna's achievements in 2025 strengthen its position in the autoimmune CAR T space, with a clear path towards BLA submission for SPS and ongoing advancements in the gMG trial.
- The appointment of Christi Shaw as Executive Chairperson and the successful follow-on offering demonstrate the company's commitment to leadership continuity and financial stability, supporting its strategic goals for 2026.
Kyverna Therapeutics is on a promising trajectory for 2026, with key milestones like the BLA submission for SPS, progress in the gMG trial, and strategic leadership updates. The company's financial strength and focus on innovation position it well for continued growth in the autoimmune therapy market.