Kyverna Therapeutics, Inc. (KYTX) Form 8-K — May 12, 2026
Kyverna Therapeutics announced the initiation of a rolling Biologics License Application (BLA) submission for miv-cel in stiff person syndrome (SPS) following a positive pre-BLA meeting where the FDA aligned on the single-arm KYSA-8 pivotal trial design. The company anticipates completing the submission in the fourth quarter of 2026 and is seeking priority review under the RMAT designation. The company reported robust primary analysis data from the KYSA-8 trial, demonstrating statistically significant and durable clinical benefit where 100% of patients remained free of immunotherapies for SPS.
Key figures
- Eps
- -0.66
- Cash Position
- 236446000
- Cash Runway
- into 2028
- Ga Expenses
- 11294000
- Rd Expenses
- 30073000
- Total Assets
- 257024000
- Weighted Avg Shares
- 60434200
- Stockholders Equity
- 195580000
Price after filing
Close on the filing date to close N calendar days later (from $10.23). Historical, not a forecast.
AI analysis
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