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Kyverna Therapeutics (KYTX) investor relations material
Kyverna Therapeutics Study update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study design and patient population
KYSA-8 is a single-arm, multicenter, open-label, phase II trial in Stiff Person Syndrome (SPS) with 26 patients who discontinued immunotherapies before miv-cel dosing.
KYSA-6 is a phase II trial in generalized Myasthenia Gravis (gMG) with seven patients who failed prior immunotherapies and stopped them before miv-cel treatment.
Both studies focus on patients with severe disease and high unmet needs who failed prior therapies.
Over 100 patients have been treated with miv-cel across autoimmune indications, showing consistent safety and efficacy.
Efficacy results in SPS (KYSA-8)
At one year, 95% of SPS patients maintained clinically meaningful improvement in the timed 25-ft walk test, with 24 of 26 remaining off immunotherapies.
Median walk time reduced by 49% from baseline at one year, with over one-third achieving healthy adult walking speed.
Statistically significant improvements were sustained across all primary and secondary endpoints at one year.
67% of patients who previously needed walking aids walked unassisted at one year.
92% of patients remained free of immunomodulatory or immunosuppressant therapies for SPS at one year.
Efficacy results in gMG (KYSA-6)
All seven gMG patients showed rapid and robust improvements in MG-ADL and QMG scores, sustained for at least one year.
Mean MG-ADL improvement was 8.2 points at 52 weeks; QMG improved by 12.8 points at 52 weeks.
100% of patients achieved clinically meaningful responses in MG-ADL, QMG, and MGC; 57% sustained minimal symptom expression at last follow-up.
Nearly all patients remained off chronic immunotherapies, reducing treatment burden.
86% of gMG patients remained off immunosuppressants at last follow-up.
- Miv-cel offers durable remission and strong safety in SPS, with expansion into gMG and PMS planned.KYTX
Investor presentation - Miv-cel shows transformative results in SPS and gMG, with regulatory and commercial milestones ahead.KYTX
H.C. Wainwright 28th Annual Global Investment Conference - Transformative cell therapy shows strong efficacy and safety, targeting near-term approval and launch.KYTX
Morgan Stanley 24th Annual Global Healthcare Conference - Miv-cel shows unprecedented efficacy in SPS, with regulatory and commercial milestones set for 2027.KYTX
Wells Fargo 21st Annual Healthcare Conference - Miv-cel achieved durable, drug-free remission in SPS and gMG with strong safety and commercial outlook.KYTX
Corporate presentation - Q2 2026 net loss narrowed to $38.3M as miv-cel advanced with FDA RMAT and strong cash reserves.KYTX
Q2 2026 - KYV-101 demonstrates transformative efficacy in autoimmune diseases, with pivotal data expected in 2026.KYTX
Jefferies London Healthcare Conference 2025 - Strong clinical data and FDA alignment position for first CAR T launch in autoimmune diseases.KYTX
Jefferies Global Healthcare Conference 2026 - Miv-cel achieved robust efficacy and safety in SPS, supporting a 2026 FDA submission.KYTX
Study Result
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