Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026
Globe Newswire•07/10/2026•08:00 ET
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Key Highlights
- ➤KYSA-8 one-year SPS data to show sustained clinical benefit after single-dose miv-cel
- ➤KYSA-8 safety profile reported without high-grade CRS, ICANS, or IEC-HS cases
- ➤Updated Phase 1 data continue showing encouraging miv-cel activity in progressive multiple sclerosis
- ➤Kyverna targets completing miv-cel SPS BLA submission this quarter
- ➤Miv-cel could become first approved CAR T-cell therapy for autoimmune disease and SPS treatment
Expert Statements
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“We are excited to share these data, which demonstrate the sustained clinical benefit achieved following a single dose of miv-cel in our registrational SPS trial, alongside encouraging findings from the updated Phase 1 IIT study in progressive multiple sclerosis”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“Together, these data, combined with a well-tolerated safety profile, reinforce our confidence in miv-cel’s differentiated profile and potential to redefine the treatment paradigm for neurologic autoimmune diseases.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“As we advance toward completing our BLA in our initial indication this quarter, we are also laying the groundwork for the commercial launch of miv-cel, which, if approved, could become the first CAR T-cell therapy for autoimmune disease and the first approved treatment for SPS.”
Full one-year results from the KYSA-8 registrational trial in stiff person syndrome to be reported, demonstrating sustained clinical benefit and a well-tolerated safety profile with no high-grade CRS or ICANS and no cases of IEC-HS
Updated Phase 1 investigator-initiated trial data to be presented, continuing to highlight encouraging clinical activity and a well-tolerated safety profile in progressive multiple sclerosis
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