KYTX Stock Just Surged 11% Today – What Is The Connection With Stiff Person Syndrome?

• According to the topline data, patients experienced statistical gains in mobility and function.
• All enrolled subjects remained free from ongoing immunotherapies at the last follow-up, and none needed rescue interventions. 
• Based on this data, Kyverna plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the first half of 2026.

Kyverna Therapeutics, Inc. (KYTX) shares drew significant investor attention on Monday morning after the company announced promising outcomes from its registrational Phase 2 study of the experimental CAR T-cell therapy mivocabtagene autoleucel (miv-cel) in patients with stiff person syndrome.

Stiff person syndrome is a rare and disabling autoimmune condition with no approved treatments.

Positive Trial Outcomes

In the KYSA-8 trial, a single infusion of miv-cel delivered sustained improvements in both primary and secondary disease measures. The 26 participants enrolled in the study were followed through the main analysis at 16 weeks, with additional observations continuing thereafter.

According to the topline data, patients experienced statistical gains in mobility and function. For the primary timed 25-foot walk endpoint, median performance improved 46% compared with baseline, with 81% surpassing a clinically meaningful threshold. 

Following the trial outcome, Kyverna’s stock traded over 11% higher in Monday’s premarket. On Stocktwits, retail sentiment around the stock improved to ‘extremely bullish’ from ‘bullish’ territory the previous day. Message volume changed to ‘extremely high’ from ‘high’ levels in 24 hours. 

Secondary disability and stiffness indices also improved markedly. Among those who needed walking aids before therapy, two-thirds no longer required assistance by week 16.

Elimination Of Chronic Treatments

All enrolled subjects remained free from ongoing immunotherapies at the last follow-up, and none needed rescue interventions. 

“Today’s topline data represent a significant breakthrough in the treatment of stiff person syndrome, demonstrating miv-cel’s ability to reverse progressive disability in a debilitating disease that has no approved therapies,” said Naji Gehchan, Chief Medical and Development Officer of Kyverna Therapeutics. 

Based on this data, Kyverna plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the first half of 2026.

KYTX shares have surged nearly 124% this year.

Also See: Why Did Goldman Sachs Downgrade Arm Holdings Stock?

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