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Visual22 Oct 2025
Epiroc's cash spent on M&A
Kyverna Therapeutics (KYTX) investor relations material
Kyverna Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary9 Sep, 2025
Company overview and clinical progress
Focused on autologous CAR-T cell therapies for autoimmune diseases, with late-stage development in Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG), having treated over 100 patients.
Achieved first-mover advantage in neuroimmunology, aiming for BLA filings and commercialization.
SPS pivotal Phase 2 study fully enrolled, with data readout and BLA filing planned for the first half of next year.
MG pivotal Phase 3 study underway, with interim Phase 2 data expected in Q4 this year.
Early data in multiple sclerosis (MS) and rheumatoid arthritis (RA) to be shared in Q4, with plans to expand into these indications.
Therapeutic innovation and differentiation
KYV-101 features a CD19 CAR with a CD28 co-stimulatory domain, designed for improved safety and durable efficacy.
Demonstrated long-term, drug-free remission in compassionate use patients, with some out to 24 months.
Unique construct enables deep B cell depletion in targeted tissues, differentiating from mRNA CARs and other therapies.
No high-grade CRS or ICANS observed in over 100 treated patients.
KYV-102, a next-generation construct, will use rapid manufacturing and whole blood, reducing turnaround time and cost.
Clinical trial design and strategy
Phase 3 MG study includes patients with prior immunosuppressant or biologic exposure, aiming to demonstrate superiority over standard of care.
60-patient KYSA 6 trial randomizes patients to KYV-101 or standard of care, with 24-week co-primary endpoints (MGADL and QMG score reduction).
Crossover allowed at 24 weeks for standard of care arm, with long-term follow-up to 18 months and beyond.
SPS chosen as first indication for rapid enrollment and first-mover advantage, creating a foundation for broader commercialization.
SPS: How does it set up future market access?
How does KYV-101 compete vs. chronic biologics?
KYV-102: How does it expand market reach?
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Next Kyverna Therapeutics earnings date
Study Update29 Oct, 2025
Next Kyverna Therapeutics earnings date
Study Update29 Oct, 2025
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Frequently asked questions
Kyverna Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies for autoimmune diseases. The company focuses on chimeric antigen receptor (CAR) T-cell therapies, which are designed to reset the immune system and potentially offer sustained treatment-free remission for patients. Kyverna’s main product candidate, KYV-101, is an autologous CD19 CAR T-cell therapy currently in clinical trials for various autoimmune conditions such as lupus nephritis, systemic sclerosis, myasthenia gravis, and multiple sclerosis. Additionally, Kyverna is developing KYV-201, an allogeneic CAR T-cell therapy, and exploring treatments for other autoimmune diseases including inflammatory bowel diseases like Crohn's disease and ulcerative colitis. The company is headquartered in Emeryville, California, and its shares are listed on the NASDAQ.
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