RegulatoryMay 12, 2026, 04:05 PM
Kyverna Initiates Rolling BLA for miv-cel in SPS After Positive FDA Meeting
AI Summary
Kyverna Therapeutics initiated a rolling Biologics License Application (BLA) submission for miv-cel in Stiff Person Syndrome (SPS) after a positive pre-BLA meeting with the FDA, gaining alignment on the regulatory path, including the sufficiency of the single-arm KYSA-8 trial. The company anticipates completing the submission in Q4 2026, seeking priority review. Additionally, Kyverna reported Q1 2026 financial results, including a net loss of $39.7 million and $236.4 million in cash, with a runway into 2028. Progress was also noted in gMG and PMS clinical trials, and Nadia Dac was appointed Chief Commercial Officer.
Key Highlights
- FDA alignment reached for miv-cel BLA submission in Stiff Person Syndrome (SPS) based on KYSA-8 single-arm trial.
- Rolling BLA submission for miv-cel in SPS initiated, targeting completion in Q4 2026 with priority review.
- KYSA-8 trial showed 100% of SPS patients remained free of immunotherapies through Week 16.
- Cash, cash equivalents, and marketable securities totaled $236.4 million as of March 31, 2026.
- Net loss for Q1 2026 was $39.7 million, or $0.66 per common share.
- R&D expenses for Q1 2026 were $30.1 million.
- Nadia Dac appointed Chief Commercial Officer to strengthen commercial expertise.