Kyverna Stock Skyrockets 52% on Positive Autoimmune Disease Trial Data
The clinical-stage biotech plans to seek FDA approval for its CAR T-cell therapy, miv-cel, after it showed significant promise in treating the rare neurological disorder Stiff Person Syndrome.
Shares of Kyverna Therapeutics (NASDAQ: KYTX) surged more than 52% in morning trading after the company announced positive results from a pivotal mid-stage trial of its lead drug candidate, miv-cel (KYV-101), for the treatment of Stiff Person Syndrome (SPS), a rare and debilitating autoimmune disorder.
The Emeryville, California-based company is developing miv-cel as a CAR T-cell therapy, a cutting-edge approach that modifies a patient's own immune cells to combat disease. Following the successful trial, Kyverna announced its intention to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the first half of 2026. An approval would position miv-cel as the first CAR T-cell therapy for any autoimmune disease, marking a major milestone for both the company and the field of medicine.
According to the company's official announcement, the registrational Phase 2 KYSA-8 trial met its primary and secondary endpoints with high statistical significance. The data showed a median 46% improvement in patients' mobility, as measured by the timed 25-foot walk, at 16 weeks compared to baseline (p=0.0002). Furthermore, 81% of patients experienced a clinically meaningful improvement, and all secondary endpoints, which measured other functional outcomes, also showed highly significant benefits (p<0.0001).
The therapy was also well-tolerated. Kyverna reported no instances of high-grade Cytokine Release Syndrome (CRS) or Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS), which are common and potentially dangerous side effects associated with CAR T-cell therapies traditionally used in oncology.
Stiff Person Syndrome is a progressive neurological disorder characterized by severe muscle stiffness and painful spasms. The condition, which affects the central nervous system, can be severely disabling, leading to an inability to walk or perform daily tasks. According to the Cleveland Clinic, the exact cause is unknown, but it is believed to be an autoimmune reaction where the body's immune system attacks its own nerve cells.
The powerful trial results provide a significant de-risking event for Kyverna, a clinical-stage company with no revenue to date. The market's enthusiastic response pushed the stock price to levels approaching its 52-week high. Even before this data, Wall Street analysts were bullish on Kyverna's prospects. Based on six analyst ratings, the stock holds a consensus 'Strong Buy' rating with an average price target of $25.25. The positive data could prompt a wave of revised price targets in the coming days.
This trial success is a crucial validation of Kyverna's platform and its strategy to apply the power of cell therapy beyond cancer and into the vast market for autoimmune diseases. A successful BLA submission and potential FDA approval for miv-cel in Stiff Person Syndrome would not only provide a much-needed treatment for patients but would also establish a clear regulatory and commercial path for its use in other autoimmune conditions that Kyverna is targeting.
Investors will now be closely watching for the formal BLA submission in 2026 and the subsequent FDA review process. With these landmark results, Kyverna Therapeutics has solidified its position as a key player in the next frontier of cell therapy.