RegulatoryMay 12, 2026, 04:12 PM
Kyverna Initiates Rolling BLA for SPS; Q1 Net Loss $39.7M
AI Summary
Kyverna Therapeutics announced the initiation of a rolling Biologics License Application (BLA) submission for miv-cel in Stiff Person Syndrome (SPS) following positive FDA alignment, with completion anticipated in Q4 2026. The company also reported first-quarter 2026 financial results, including a net loss of $39.7 million and $236.4 million in cash, cash equivalents, and marketable securities. Additionally, Kyverna provided updates on advancing its Phase 3 trial in generalized myasthenia gravis (gMG) and positive data in progressive multiple sclerosis (PMS), alongside the appointment of a Chief Commercial Officer.
Key Highlights
- Initiated rolling Biologics License Application (BLA) submission for miv-cel in Stiff Person Syndrome (SPS).
- FDA alignment reached on KYSA-8 single-arm pivotal Phase 2 trial being sufficient for BLA submission.
- Anticipates completing BLA submission in Q4 2026, seeking priority review under RMAT designation.
- Reported Q1 2026 net loss of $39.7 million, an improvement from $44.6 million in Q1 2025.
- Cash, cash equivalents, and marketable securities totaled $236.4 million as of March 31, 2026.
- Research and Development (R&D) expenses were $30.1 million for Q1 2026.
- Net loss per common share was $0.66 for Q1 2026, down from $1.03 in Q1 2025.
- Appointed Nadia Dac as Chief Commercial Officer to strengthen commercial expertise.