Kyverna Therapeutics, Inc. KYTX
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a CNS/neurology/psychiatry drug developer. Its lead program, miv-cel (KYV-101), is in Phase 3 for Stiff person syndrome. Its next catalyst on record is miv-cel SPS: Complete rolling BLA submission (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: miv-cel SPS — Complete rolling BLA submission (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| miv-cel (autologous anti-CD19 CAR-T) - stiff person syndrome, KYSA-8 registrational Phase 2 (complete); rolling BLA | Stiff person syndrome | cell therapy | Phase 3 |
| miv-cel - generalized myasthenia gravis, registrational Phase 3 | Generalized myasthenia gravis | cell therapy | Phase 3 |
| miv-cel - non-active secondary progressive MS (RMAT) | naSPMS | cell therapy | Phase 2 |
| KYV-102 | Not specified in extract | cell therapy | Phase 1 |
Recent results and decisions
- Sep 24, 2026positive 12-month KYSA-8 data (n=26): T25FW improvement sustained (p<0.0001), median 49% at month 12 vs 46% at Week 16; 92% remain free of chronic immunotherapies; no high-grade CRS/ICANS.
Significant timed 25-Foot Walk (T25FW) improvement sustained at month 12 (p < 0.0001): median improvement from baseline of 46% at week 16 and 49% at month 12
Filing - May 12, 2026submitted Rolling BLA submission initiated for miv-cel in SPS after positive pre-BLA meeting with FDA; completion anticipated Q4 2026 with priority review sought under RMAT.
The Company has initiated its rolling BLA submission, seeking priority review under the program’s Regenerative Medicine Advanced therapy (RMAT) designation, and anticipates completing the submission in Q4 2026.
Filing - May 12, 2026positive Stanford Phase 1 IIT (n=6, up to 12 months): all 5 patients with assessments improved or stable on EDSS, 4/4 improved fatigue, no high-grade CRS or ICANS.
Of the 5 patients with post-treatment assessments, all achieved improvement or stability in their disability scores at last follow up, as measured by the expanded disability status scale scores (EDSS).
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.