Miv-cel (mivocabtagene autoleucel, KYV-101) - (KYSA-8)
- Indication
- Stiff-person syndrome (SPS)
- Stage
- phase3
- Event
- Conference Presentation
- Details
October 7, 2026: Kyverna Therapeutics (NASDAQ: KYTX) said two miv-cel (mivocabtagene autoleucel; formerly KYV-101) abstracts were selected for presentation at the MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting in Toronto on October 21-23, 2026.
Miv-cel in stiff person syndrome (SPS): full 1-year results from the registrational KYSA-8 pivotal multicenter Phase 2 trial will be presented in a poster on October 21. The company said the data show sustained clinical benefit and a well-tolerated safety profile, with no high-grade CRS or ICANS and no cases of IEC-HS.
Miv-cel in progressive multiple sclerosis: updated data from an investigator-initiated Phase 1 study will be presented orally on October 23. The company said the update continues to show encouraging clinical activity and a well-tolerated safety profile.
Regulatory/upcoming catalyst: Kyverna said it expects to complete its rolling BLA submission for miv-cel in SPS this quarter. The release also notes an ongoing registrational trial of miv-cel in generalized myasthenia gravis and that the product has FDA RMAT designations in SPS, gMG, and non-active secondary progressive multiple sclerosis.
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