Kyverna reports positive one-year SPS data and longer-term gMG follow-up for miv-cel
Kyverna Therapeutics said one-year topline data from its KYSA-8 registrational trial in stiff person syndrome (SPS) and longer-term Phase 2 follow-up data from KYSA-6 in generalized myasthenia gravis (gMG) were positive. The company said it remains on track to complete its rolling BLA submission in Q4 2026, and the filing contains no financial results, guidance, or deal terms.
Key points
- KYSA-8: median timed 25-Foot Walk improvement of 49% at month 12 among 26 SPS patients (p < 0.0001)
- KYSA-6 Phase 2: all 7 gMG patients reached clinically meaningful improvement at 24 weeks; 57% maintained minimal symptom expression at last follow-up
- Rolling BLA submission for miv-cel in SPS is on track for completion in Q4 2026; full data at MS Toronto, October 21-23, 2026
- Conference call set for 8:00 a.m. Eastern Time on September 24, 2026
The filing
Written by AI on Nov 9, 2026, 11:46 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 24, 2026.
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