What Kyverna Therapeutics does

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing engineered T-cell therapies for B-cell-driven autoimmune diseases. The company's lead candidate, mivocabtagene autoleucel (miv-cel, also designated KYV-101), is an autologous CAR-T therapy built on a fully human anti-CD19 chimeric antigen receptor construct designed to reduce immunogenicity compared with murine-based predecessors. The pipeline also extends to allogeneic and next-generation formats (KYV-201 and KYV-102) developed on the company's Ingenui-T manufacturing platform. Kyverna initiated the first rolling Biologics License Application for a CAR-T therapy in an autoimmune indication, targeting stiff person syndrome (SPS), and is running parallel KYSA Phase 1/2 trials in generalized myasthenia gravis, lupus nephritis, multiple sclerosis, systemic sclerosis, and rheumatoid arthritis.

The company is headquartered in Emeryville, California, completed its initial public offering on Nasdaq (ticker KYTX) in 2024, and subsequently raised additional capital through a 2025 follow-on equity offering and a $150 million non-dilutive term loan facility with Oxford Finance. The senior leadership team has been deliberately built with executives drawn from Kite Pharma, the first company to commercialize an autologous CAR-T therapy, signaling preparation for a commercial launch in the United States. A manufacturing automation partnership with Multiply Labs reflects investment in reducing cost-of-goods and scaling treatment-center throughput, both critical to extending CAR-T beyond oncology.

Kyverna's intended business model is a specialty biopharma model in which an autologous cell therapy is delivered through authorized treatment centers under a buy-and-bill reimbursement framework typical of high-cost cell and gene therapies. The company is pre-revenue and pre-commercial, with no approved product; revenue generation is contingent on regulatory approval, manufacturing scale-up, and successful launch execution across multiple rare autoimmune indications.

Name

Kyverna Therapeutics

Legal name

Kyverna Therapeutics, Inc.

Website

https://kyvernatx.com

Company type

Public

Founded year

2020

Operating status

Ipo

Headcount range

101–250 employees

Short description

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing autologous and allogeneic anti-CD19 CAR T-cell therapies for B-cell-driven autoimmune diseases, with lead candidate miv-cel (KYV-101) advancing through registrational trials in stiff person syndrome, myasthenia gravis, lupus nephritis, and multiple sclerosis.

Ownership category

akta.pro rank

Product category

Cell Therapy Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Medical and Diagnostic Laboratories (62151), Medical and Diagnostic Laboratories (6215)

SIC

Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835), Pharmaceutical Preparations (2834)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Autoimmune & Allergy Diagnostics (HLAAALAK), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE), Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

Keywords

• CAR T-cell therapy
• Cell therapy autoimmune
• Anti-CD19 immunotherapy
• Clinical-stage biopharmaceutical
• B-cell depletion therapy

Headquarters

HQ city

Berkeley

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Future cell therapy product sales (miv-cel / KYV-101): Pre-revenue clinical-stage biopharmaceutical company; primary future revenue stream will come from one-time sales of autologous CAR-T cell therapy doses administered at authorized treatment centers. Buy-and-bill reimbursement model is being prepared for in the CAR T Channel Strategy & Operations build-out, with specialty pharmacy and 3PL distribution infrastructure planned. Initial commercial launch targeted in stiff person syndrome with expansion into generalized myasthenia gravis, lupus nephritis, multiple sclerosis, rheumatoid arthritis, and systemic sclerosis.
2. Potential licensing / collaboration revenue (KYV-102 / allogeneic platform): Adjacent revenue optionality from allogeneic platform programs (KYV-201, KYV-102) and external collaborations such as the Multiply Labs pilot to automate CAR-T manufacturing, which could enable licensing or partnership economics as the platform matures.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels8 records

Core offering

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing CAR T-cell therapies (chimeric antigen receptor T-cell therapies) for serious B-cell-driven autoimmune diseases. Its lead candidate, mivocabtagene autoleucel (miv-cel / KYV-101), is a fully human anti-CD19 CAR T-cell therapy designed to deliver deep B-cell depletion and durable immune reset after a single infusion. The pipeline targets stiff person syndrome, generalized myasthenia gravis, multiple sclerosis, lupus nephritis, systemic sclerosis, and treatment-refractory rheumatoid arthritis.

Product overview

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing a single platform-plus-pipeline architecture centered on its proprietary anti-CD19 CAR T-cell therapy platform. The core product candidate mivocabtagene autoleucel (miv-cel / KYV-101) — a fully human autologous anti-CD19 CAR T-cell therapy — is the lead asset and is being evaluated across neurology and rheumatology autoimmune indications (stiff person syndrome, myasthenia gravis, multiple sclerosis, systemic sclerosis, and lupus nephritis). Building on the KYV-101 program, the pipeline expands into next-generation candidates including the allogeneic anti-CD19 CAR T-cell therapy KYV-201 and the manufacturing-automated candidate KYV-102 (developed in collaboration with Multiply Labs), supported internally by the rapid whole-blood autologous manufacturing process Ingenui-T. Together these constitute Kyverna's portfolio of B-cell-targeted CAR T-cell therapies intended to deliver durable, drug-free remission after a single infusion in B-cell-driven autoimmune diseases.

Differentiator

Problem solved

Functional benefit

Brands

• mivocabtagene autoleucel: Lead CAR T-cell therapy candidate, also referred to as miv-cel or KYV-101, an autologous anti-CD19 CAR T-cell product targeting B cells in autoimmune diseases.
• KYV-201

Products and services

• Mivocabtagene autoleucel (miv-cel, KYV-101) Fully human anti-CD19 CAR T-cell therapy candidate (autologous) and Kyverna's lead asset, advancing through clinical development in rheumatology and neurology autoimmune indications including stiff person syndrome, myasthenia gravis, multiple sclerosis, systemic sclerosis, and lupus nephritis. Designed to achieve deep B-cell depletion, immune reset, and durable drug-free remission after a single administration.
• KYV-201 Investigational allogeneic (off-the-shelf) anti-CD19 CAR T-cell therapy for the treatment of autoimmune disease, intended to complement Kyverna's autologous KYV-101 by eliminating the need for patient-specific manufacturing.
• KYV-102 CAR-T cell therapy candidate whose manufacturing is being automated in a pilot collaboration with Multiply Labs (initiated mid-2025), using cloud-controlled robotic systems to reduce manufacturing cost and increase throughput.

Quantifiable outcome

• 46% median improvement in walking ability (T25FW) at week 16 in KYSA-8 SPS registrational trial
• +4 more outcomes

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Multiply LabsmoderateTechnology or Integration · 1 June 2025Pilot collaboration initiated mid-2025 to automate manufacturing of Kyverna's CAR-T candidate KYV-102 using Multiply Labs' cloud-controlled robotic systems. Multiply Labs has demonstrated 74% reduction in manufacturing costs and up to 100x more patient doses per square foot of cleanroom versus manual processes. Kyverna is among Multiply Labs' strategic partners alongside AstraZeneca, NVIDIA, Thermo Fisher Scientific, Legend Biotech, WuXi STA, Charles River Laboratories, and Cytiva.

Scale indicators15 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Cabaletta Bio: Clinical-stage biotech developing CD19 CAR-T cell therapies (e.g., CABA-201) for autoimmune diseases including lupus, myositis, and pemphigus. Direct competitor to Kyverna in the autoimmune CAR-T space with overlapping anti-CD19 mechanism and B-cell depletion thesis.
• Cartesian Therapeutics: Clinical-stage company developing mRNA-engineered cell therapies for autoimmune diseases, including Cartesian's lead program in myasthenia gravis. Directly competes with Kyverna's miv-cel in gMG and pursues a similar cell-therapy-for-autoimmune repositioning strategy.

Broad incumbents

• Bristol Myers Squibb: Large pharmaceutical company with approved CD19 CAR-T therapy Breyanzi (lisocabtagene maraleucel) in oncology and active autoimmune pipeline. Represents both a competitor and potential acquirer/partner for Kyverna given overlapping CD19 CAR-T modality and autoimmune ambitions.
• Gilead Sciences (Kite Pharma): Owns Kite Pharma, the leading commercial CAR-T franchise (Yescarta, Tecartus) and a Series B investor in Kyverna. Kite is the most established CAR-T commercial organization and a direct comparator for Kyverna's commercial buildout, while also being a potential strategic acquirer.
• Novartis: Pioneer of CAR-T therapy with Kymriah (tisagenlecleucel) and a major biopharmaceutical incumbent with deep cell therapy manufacturing infrastructure. Multiple Kyverna executives (e.g., CTO Mayo Pujols) came from Novartis cell and gene therapy operations.
• Johnson & Johnson: Co-developer of Carvykti (BCMA CAR-T) with Legend Biotech, giving J&J deep CAR-T commercial and manufacturing capability relevant to Kyverna's launch model. Broad biopharma incumbent exploring autoimmune applications of cell therapy.

Emerging players

• Allogene Therapeutics: Clinical-stage biotech developing allogeneic (off-the-shelf) CAR-T therapies with a platform that mirrors Kyverna's allogeneic KYV-201 ambitions. Comparable on modality and pipeline breadth, with deeper oncology focus but adjacent autoimmune relevance.
• Atara Biotherapeutics: Clinical-stage allogeneic T-cell therapy company with a comparable leadership connection (Kyverna CBO Dan Maziasz was formerly Atara's CBO). Atara's tabelecleucel and allogeneic platform overlap with Kyverna's KYV-201 in modality and target indications.
• Caribou Biosciences: Clinical-stage allogeneic CAR-T developer using CRISPR-edited cell therapies (CB-010, CB-012). Comparable to Kyverna on next-generation engineered cell therapy platform though focused primarily on oncology, with potential autoimmune expansion.

Others

• CRISPR Therapeutics: Gene-editing cell therapy company with Casgevy (exa-cel) approval and an active autoimmune pipeline (CTX112, CTX131). Thematically aligned as a next-generation cell therapy platform, with overlapping modality but differentiated gene-editing versus CAR-T approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kyverna

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds5 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kyverna Therapeutics