Kyverna Therapeutics Stock Up 41% in a Month: Here's Why

Kyverna Therapeutics’ KYTX lead CAR T-cell therapy candidate, mivocabtagene autoleucel (“miv-cel”, formerly KYV-101), is being developed in a pivotal phase II study for stiff person syndrome (SPS), a rare, debilitating and progressive autoimmune disease with no FDA-approved therapies and significant unmet medical need. The candidate has the potential to become the first FDA-approved CAR T therapy for an autoimmune disease.

In mid-December, Kyverna announced positive top-line data from the SPS study. Data from the study showed that miv-cel, with a single dose, achieved highly statistically significant and sustained improvements in overall disability, mobility, and stiffness in patients with SPS, while allowing them to stay free from immunotherapies, which carry high safety risks.

The study met the primary and all secondary endpoints with high statistical significance. The median improvement in the timed 25-foot walk (T25FW) test — the study’s primary endpoint — was 46% in patients treated with miv-cel. The T25FW test is a validated tool to assess walking ability as well as to evaluate stiffness and loss of mobility.

Kyverna plans to file a biologics license application (BLA) for SPS in the first half of 2026. If approved by the FDA, miv-cel will become the first approved therapy for SPS.

Kyverna’s success in the phase II study in SPS led the stock to rise 41% in a month, outperforming the industry’s increase of 2.7%.

More on KYTX’s Miv-cel’s Progress

Miv-cel has received both Regenerative Medicine Advanced Therapy and Orphan Drug designations in the SPS indication.

Another phase II/III registrational study is evaluating miv-cel in generalized myasthenia gravis (gMG). Interim data from the phase II portion of the study demonstrated miv-cel’s potential to deliver durable, drug-free, disease-free remission. Kyverna expects to initiate patient enrollment in the phase III portion of the study soon and provide updated data from the phase II portion in 2026.  

Miv-cel is also being evaluated in phase I/II investigator-initiated studies, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the company to advance into late-stage development.

In November, Kyverna closed a loan facility for up to $150 million with Oxford Finance, which has strengthened its financial flexibility to support continued development of its pipeline candidates.

Zacks Rank and Stocks to Consider

Kyverna has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL. ANIP, CRMD and CSTL currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 adjusted EPS have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 47.1% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while estimates for 2026 have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 57.3% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents for 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 47.4% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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