Kyverna Therapeutics Stock Price, News & Analysis

Kyverna Therapeutics (NASDAQ: KYTX) announced positive interim Phase 2 data from the KYSA-6 study of KYV-101 in generalized myasthenia gravis on October 29, 2025.

In six treated patients (data cutoff Oct 3, 2025) a single 1×10^8 CAR+T dose produced mean MG-ADL -8.0 and QMG -7.7 point changes at 24 weeks; 100% (6/6) met co-primary clinical response thresholds and 100% were free of several background immunosuppressive treatments through 24 weeks. Safety showed no Grade ≥3 CRS and no ICANS; one Grade 4 neutropenia resolved to Grade 1 by cutoff.

Kyverna Therapeutics (Nasdaq: KYTX) reported Phase 1 investigator-initiated trial results for KYV-101 in difficult-to-treat rheumatoid arthritis presented at ACR Convergence 2025.

In six ACPA-positive, treatment-refractory patients given a single 1×108 KYV-101 infusion (follow-up 28–175 days), CAR T cells expanded rapidly (peak 14–21 days), B cells were depleted in all patients, and profound reductions in ACPA and RF-IgM were observed. Four of six achieved ACR20 and two achieved ACR50. Safety showed no high-grade CRS or ICANS. These data supported initiation of the randomized Phase 2 portion, with enrollment completed.

Kyverna Therapeutics (Nasdaq: KYTX) will host a conference call on Wednesday, October 29, 2025 at 8:00 AM ET to discuss interim Phase 2 data from the KYSA-6 study of KYV-101 in generalized myasthenia gravis (gMG). The interim data will also be presented at the American Association of Neuromuscular and Electrodiagnostic Medicine Annual Meeting in San Francisco on October 29–November 1, 2025.

The AANEM presentation, titled "Update on the Phase 2 Part of KYSA-6," will be given by Srikanth Muppidi, M.D. on Wednesday, October 29, 2025 at 11:00 AM PT. The call requires registration to receive dial-in and PIN; a live webcast, presentation materials, and archived replay will be available on Kyverna's Investor Relations "Events & Presentations" page at ir.kyvernatx.com.

Kyverna Therapeutics (Nasdaq: KYTX) announced updated Phase 1 data for KYV-101 in progressive multiple sclerosis (MS) to be presented at the 2025 ECTRIMS Congress. The data comes from investigator-initiated trials at Stanford Medicine and UCSF.

Key findings include: robust CAR T-cell penetration into the central nervous system, improved disability status scores (EDSS), and a tolerable safety profile with no high-grade adverse events. Stanford's trial enrolled 6 patients (4 treated) while UCSF's study included 2 patients, all showing disease stabilization or improvement. The therapy demonstrated successful immune reset potential, evidenced by B-cell reconstitution to a naive phenotype in multiple patients.

Kyverna Therapeutics (Nasdaq: KYTX) announced it will present interim Phase 2 data from its KYSA-6 study of KYV-101 in myasthenia gravis (MG) at the AANEM Annual Meeting in October 2025. The presentation will include topline efficacy and safety data for 6 patients with up to 9 months of follow-up.

The company has successfully transformed the Phase 2 open-label study into a registrational Phase 2/3 trial following FDA alignment. Kyverna plans to initiate the Phase 3 portion by year-end 2025. The study evaluates KYV-101, a CD19 CAR T-cell therapy designed to achieve durable drug-free, disease-free remission with a single dose in patients with generalized myasthenia gravis (gMG).

Kyverna Therapeutics (Nasdaq: KYTX) announced details of its Phase 3 registrational trial design for KYV-101, a CD19-directed CAR T-cell therapy, in myasthenia gravis (MG). The KYSA-6 Phase 2/3 trial will enroll approximately 60 patients randomized 1:1 to receive either KYV-101 or standard-of-care therapy.

The trial aims to demonstrate KYV-101's potential to deliver durable, drug-free, disease-free remission in MG patients. Key endpoints include changes in MG-ADL and QMG scores at 24 weeks. The company expects to initiate Phase 3 enrollment by year-end 2025 and will report interim Phase 2 data in Q4 2025.

The therapy is also being developed for stiff person syndrome (SPS), with positive longer-term follow-up data reported from compassionate use patients in both indications.

Kyverna Therapeutics (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, has announced its participation in three major investor conferences in September 2025.

CEO Warner Biddle will participate in fireside chat presentations at the 2025 Wells Fargo Healthcare Conference (September 3rd, 11:00 a.m. ET), the Morgan Stanley 23rd Annual Global Healthcare Conference (September 8th, 4:05 p.m. ET), and the H.C. Wainwright 27th Annual Global Investment Conference (September 9th, 11:00 a.m. ET).

Investors can access live webcasts through Kyverna's investor relations website, with replays available for 90 days post-events.

Kyverna Therapeutics (Nasdaq: KYTX) reported Q2 2025 financial results and provided key business updates. The company maintains a strong cash position of $211.7 million, expected to fund operations into 2027. Key highlights include completion of patient enrollment in the registrational Phase 2 trial for stiff person syndrome (SPS), with topline data and BLA submission anticipated in 1H 2026.

The company plans to initiate a Phase 3 registrational trial for myasthenia gravis (MG) by year-end 2025, involving approximately 60 patients, with interim Phase 2 data expected in Q4 2025. For Q2 2025, Kyverna reported a net loss of $42.1 million ($0.97 per share), compared to $28.8 million ($0.67 per share) in Q2 2024. R&D expenses increased to $35.8 million from $27.3 million year-over-year.

Kyverna Therapeutics (Nasdaq: KYTX) announced a virtual Key Opinion Leader (KOL) event scheduled for August 28, 2025, from 11:00am to 1:30pm ET. The event will focus on the company's neuroimmunology CAR T franchise, featuring presentations from distinguished medical experts and management team members.

The webcast will highlight KYV-101's potential in treating myasthenia gravis (MG) and stiff person syndrome (SPS), including the Phase 3 registrational trial in MG. Key topics will cover treatment landscapes, patient experiences, unmet needs, and the company's commercial strategy. The event will conclude with a Q&A session and will be accessible through the company's investor relations website.