Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026

Kyverna is laying the groundwork for a commercial launch of miv-cel, subject to approval.

Rhea-AI Summary

Kyverna Therapeutics (KYTX) will present miv-cel trial results in stiff person syndrome and progressive multiple sclerosis at MSToronto2026, October 21–23.

The one-year KYSA-8 Phase 2 results show sustained clinical benefit following a single dose, which Kyverna characterizes as well tolerated. No high-grade cytokine release syndrome or immune-related neurological toxicity, and no cases of immune effector cell-associated hemophagocytic syndrome, an inflammatory complication, were reported. Updated Phase 1 investigator-initiated multiple sclerosis data will cover preliminary efficacy and safety; the company describes clinical activity as encouraging. Kyverna plans to complete its biologics license application for its initial indication this quarter.

5 points · 0 major

PositiveiHow this balance works

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointKYSA-8 results demonstrate sustained clinical benefit at one year following a single dose of miv-cel.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Kyverna plans to complete its biologics license application this quarter for its initial indication.
• Minor pointKYSA-8 safety findings include no high-grade CRS or ICANS and no cases of IEC-HS.
• Minor pointUpdated progressive multiple sclerosis data show encouraging clinical activity and a well-tolerated safety profile, in Kyverna's assessment.
• Minor pointKyverna is laying the groundwork for commercial launch of miv-cel.

Negative

• Minor pointProgressive multiple sclerosis efficacy findings remain preliminary in a Phase 1 investigator-initiated study.
• Minor point. Forward-looking: it has not happened yet and may not happen.Miv-cel's potential commercial launch remains subject to approval.

Key Terms

icans, car t-cell therapy

2 terms

icans medical

"no high-grade CRS or ICANS"

ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) is a range of brain-related side effects that can occur after certain immune-cell cancer therapies, such as CAR-T. Symptoms can include confusion, speech problems, seizures or reduced consciousness, and they are caused by an overactive immune response affecting the brain. Investors care because ICANS can influence patient safety, trial outcomes, regulatory approvals, treatment labeling and adoption, all of which affect a therapy’s commercial prospects and development costs.

car t-cell therapy medical

"CD19 CAR T-Cell Therapy in Stiff Person Syndrome"

Car T-cell therapy is a medical treatment that uses a patient’s own immune cells, modified in a lab to better recognize and attack cancer cells. It is considered a breakthrough because it offers potentially long-lasting effects for certain types of cancer. For investors, its development and approval can signal advances in healthcare innovation and potential growth opportunities in the biotech sector.

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Full one-year results from the KYSA-8 registrational trial in stiff person syndrome to be reported, demonstrating sustained clinical benefit and a well-tolerated safety profile with no high-grade CRS or ICANS and no cases of IEC-HS 

Updated Phase 1 investigator-initiated trial data to be presented, continuing to highlight encouraging clinical activity and a well-tolerated safety profile in progressive multiple sclerosis

EMERYVILLE, Calif., Oct. 07, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced two abstracts selected for presentation at the MSToronto2026 10^th Joint ACTRIMS-ECTRIMS Meeting, taking place from October 21-23, 2026, in Toronto, Canada.

“We are excited to share these data, which demonstrate the sustained clinical benefit achieved following a single dose of miv-cel in our registrational SPS trial, alongside encouraging findings from the updated Phase 1 IIT study in progressive multiple sclerosis,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “Together, these data, combined with a well-tolerated safety profile, reinforce our confidence in miv-cel’s differentiated profile and potential to redefine the treatment paradigm for neurologic autoimmune diseases. As we advance toward completing our BLA in our initial indication this quarter, we are also laying the groundwork for the commercial launch of miv-cel, which, if approved, could become the first CAR T-cell therapy for autoimmune disease and the first approved treatment for SPS.”

Poster Presentation:
Title: 1-Year Analysis of KYSA-8: the Pivotal, Multicenter, Phase 2 Study of Miv-cel (Mivocabtagene Autoleucel; Formerly KYV-101) CD19 CAR T-Cell Therapy in Stiff Person Syndrome
Presenter: Dr. Amanda Piquet, M.D., FAAN, Director of Autoimmune Neurology at the University of Colorado Anschutz School of Medicine
Poster ID: P0364
Date & Time: Wed., Oct. 21, 2026, 4:30 – 6:30 PM ET

Oral Presentation:
Title: Safety and Preliminary Efficacy of CD-19 Directed CAR T-Cell Therapy in Progressive Multiple Sclerosis: A Phase 1 Study
Presenter: Dr. Jeff Dunn, M.D., Lily Sarafan Director of Neuroimmunology and Clinical Professor & Chief of Neuroimmunology in the Department of Neurology & Neurological Sciences at Stanford University
Date & Time: Friday, Oct. 23,2026, 11:05 – 11:15 AM ET

About Stiff Person Syndrome (SPS)
SPS is a rare, progressive neurologic autoimmune disease characterized by muscle stiffness and painful muscle spasms, impacting mobility and gait. Stiffness, rigidity, and spasms in the torso, arms, and legs lead to progressive disability causing up to 80% of patients to lose mobility, requiring walking aid assistance or wheelchair use^1-3. SPS has been shown to lead to permanent disability and increased risk of mortality³. Most patients with SPS have antibodies to glutamic acid decarboxylase 65 (GAD65) or the glycine receptor, which disrupt normal inhibitory neurotransmission, contributing to the hallmark symptoms of SPS. There are currently no FDA-approved treatments for SPS. Current treatment options include symptomatic treatments, off-label immunotherapies, such as intravenous immunoglobulin (IVIg), rituximab and plasmapheresis, as well as supportive care and physical, speech, occupational, and psychiatric therapy; however, the majority of patients have inadequate or no response to these treatment options. An estimated 6,000 patients are diagnosed with SPS in the United States^4-5.

About Multiple Sclerosis
Multiple sclerosis is a chronic autoimmune disease causing neurodegeneration, in which patients can experience a range of symptoms including blurred vision, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, and, in severe cases, the inability to walk or stand. B cells play a significant role in MS by producing autoantibodies that attack the protective sheath around nerves, activating T cells, and increasing inflammation. Current disease-modifying treatments for MS aim to reduce the frequency of disease relapses and delay progression of disability, but the disease remains a chronic condition that will progressively worsen for most patients.

About Miv-cel (mivocabtagene autoleucel, KYV-101)
Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation. It is uniquely designed for potency and tolerability with the potential to achieve deep B-cell depletion, reset the immune system and deliver durable drug-free, disease-free remission in autoimmune diseases with a single dose. Miv-cel is under investigation for B-cell driven autoimmune diseases and is produced using a well-established, validated manufacturing process. To date, more than 100 patients have been treated with miv-cel across a range of autoimmune diseases, and the clinical data demonstrates a consistent and well-tolerated safety profile.

About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical immunology company pioneering differentiated therapies with curative potential for neurologic autoimmune diseases. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome (SPS) and an ongoing registrational trial for generalized myasthenia gravis (gMG).

Miv-cel has received three FDA Regenerative Medicine Advanced Therapy (RMAT) designations, in SPS, gMG, and non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further reinforcing the therapy's potential across neuroimmunology. Additionally, the Company continues to advance new innovations that broaden access and choice for patients, expanding its leadership position in the field. For more information, please visit https://kyvernatx.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential for a single dose of miv-cel to achieve deep B-cell depletion, reset the immune system, and deliver durable drug-free, disease-free remission in autoimmune diseases; the potential for miv-cel to redefine the treatment paradigm for neurologic autoimmune diseases and to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases; the possibility of a commercial launch of the first CAR T-cell therapy to potentially be approved for autoimmune disease and the first approved treatment for SPS; the anticipated timing of the completion of the rolling BLA submission for miv-cel in SPS; Kyverna’s pipeline opportunities, including in progressive multiple sclerosis; and Kyverna’s potentially first-in-class neuroimmunology franchise. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions; risks related to the timing and outcome of regulatory submissions and interactions with the FDA; the ability to enroll patients in clinical trials on anticipated timelines; the possibility that topline results may change following further analysis or differ from final results; the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com

¹ Rakocevic G, et al. BMC Neurol. 2019;19:1.
² Dalakas MC. Nat Rev Neurol. 2024;20(10):587-601.
³ Duddy ME, Baker MR. Front Neurol Neurosci. 2009;26:147-165.
⁴ Crane PD, et al. Neurology. 2024;103(12):e210078.
⁵ Analysis of 2024 Komodo U.S. Claims Data.

FAQ

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What did Kyverna's one-year KYSA-8 stiff person syndrome results show?

The results demonstrate sustained clinical benefit following a single dose of miv-cel. No high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS) were reported. Kyverna describes the safety profile as well tolerated.

When does Kyverna expect to complete its miv-cel approval application?

Kyverna plans to complete its biologics license application for its initial indication this quarter. The company is also laying the groundwork for commercial launch, subject to approval.