KYTX Stock Soars After Hours: What’s Driving The Rally?

• The trial results were presented in a late-breaking oral session at the American Academy of Neurology (AAN) Annual Meeting in Chicago.
• At 16 weeks, mobility improved significantly with eighty-one percent of patients achieving a clinically meaningful improvement, the company said. 
• Kyverna said the data support its plan to submit a biologics license application (BLA) to the FDA for miv-cel in SPS.

Shares of Kyverna Therapeutics, Inc. (KYTX) jumped 24% after hours on Tuesday after the company said that its experimental one-time CAR-T cell therapy delivered rapid, lasting improvements in mobility and reversed disability in patients with stiff person syndrome (SPS) in a trial.

The results were presented in a late-breaking oral session at the American Academy of Neurology (AAN) Annual Meeting in Chicago.

Trial Results

In the phase-2 trial, 26 patients who had not responded well to standard off-label therapies received a single dose of Kyverna’s miv-cel.

At 16 weeks, mobility improved significantly; eighty-one percent of patients achieved a clinically meaningful improvement. Two-thirds of those who needed walking aids at the start no longer required them. All 26 patients were able to stop chronic immunotherapies entirely, the company said. Disability, muscle stiffness, and sensitivity to spasms also improved markedly, it added.

Miv-cel was generally well-tolerated. The most common side effect was a temporary drop in neutrophil cell counts that was manageable, Kyverna said.

What Next?

Kyverna said the data support its plan to submit a biologics license application (BLA) to the FDA for miv-cel in SPS. If approved, it would become the first approved treatment for the condition and the first CAR-T therapy approved for any autoimmune disease.

How Did Retail Traders React?

On Stocktwits, retail sentiment around KYTX stayed within the ‘extremely bullish’ territory over the past 24 hours while message volume jumped from ‘high’ to ‘extremely high’ levels.

A Stocktwits user expressed optimism for the company, highlighting the past experiences of its CEO Warner Biddle who previously worked with Kite Pharma. Kite was bought out by Gilead Sciences for $11.9 billion in 2017.

Another opined that miv-cel has a total addressable market of over $80 billion if its approved across multiple indications.

KYTX stock has gained 11% year-to-date. 

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