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Fierce Biotech·Sep 23·1 min read
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Kyverna reports year-long efficacy and clean safety for miv-cel CAR-T in autoimmune trials

Sep 23, 2026·read at Fierce Biotech ↗Positive readoutPositive

Kyverna Therapeutics released one-year data for its CAR-T candidate miv-cel in stiff person syndrome and 18-month data in generalized myasthenia gravis.

The single dose showed durable clinical benefit, with remission lasting up to 12 months in SPS and up to 18 months in gMG.

No high-grade cytokine release syndrome, ICANS, or IEC-HS events were observed, indicating a clean safety profile.

The company will add the one-year data to its FDA rolling submission for SPS, keeping the filing on track for completion in the fourth quarter.

source

This writeup was produced by pharmadog from original reporting by Fierce Biotech.

Original headline: “Kyverna ‘resetting conversation’ with 1-year miv-cel data as autoimmune CAR-T peers hit safety snags”

read at Fierce Biotech ↗
1,123 words · retrieved Sep 24
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companies & drugs in this story

companies
NOVARTIS2BRISTOLBRISTOL MYERS SQUIBBBRISTOL MYERS SQUIBB COUNIQUEUltragenyx Pharmaceutical Inc.
drugs
mivocabtagene autoleucel
topics
Immunology15CAR-T12CD195Big Pharma2Gene Therapy (AAV)2Multiple SclerosisOncologyRare Disease

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